Last updated: 11/04/2018 07:59:08
Out-Patient Study in Patients with Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin Only
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A 16-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of Multiple Doses and Multiple Treatment Regimens of GSK716155, with Byetta as an Open Label Active Reference, in Subjects with Type 2 Diabetes Mellitus
Trial description: This study is a placebo-controlled study in patients with Type 2 Diabetes Mellitus who are either taking no diabetes medication or who are taking metformin only. This study will investigate the safety, tolerability, and efficacy of Albiglutide (GSK716155) and will measure the levels of Albiglutide (GSK716155) in the bloodstream when it is given for 16 weeks. As a comparison, some subjects will receive exenatide instead of Albiglutide (GSK716155). The study will involve weekly visits for 17 weeks,and less frequent follow-up visits for an additional 10 weeks. Assessments include repeat blood sampling and monitoring of any side effects.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from Baseline in glycosylated hemoglobin (HbA1c) at Week 16
Timeframe: Baseline and Week 16
Secondary outcomes:
Change from Baseline in HbA1c at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Timeframe: Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Number of participants who achieved target values for HbA1c <6.5% and >=6.5% to <7% at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Timeframe: Weeks (W) 4, 5, 7, 8, 9, 12, 15, and 16
Change from Baseline in waist circumference at Week 16
Timeframe: Baseline and Week 16
Change from Baseline in body weight at Week 16
Timeframe: Baseline and Week 16
Percent change from Baseline in body weight at Week 16
Timeframe: Baseline and Week 16
Change from Baseline in fasting plasma glucose (FPG) at Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Timeframe: Baseline and Weeks 4, 5, 7, 8, 9, 12, 15, and 16
Change from Baseline in fasting fructosamine at Weeks 5, 8, 12, and 16
Timeframe: Baseline and Weeks 5, 8, 12, and 16
Change from Baseline in fasting C-peptide at Weeks 5, 8, 12, and 16
Timeframe: Baseline and Weeks 5, 8, 12, and 16
Change from Baseline in fasting glucagon at Weeks 5, 8, 12, and 16
Timeframe: Baseline and Weeks 5, 8, 12, and 16
Change from Baseline in fasting insulin at Weeks 5, 8, 12, and 16
Timeframe: Baseline and Weeks 5, 8, 12, and 16
Change from Baseline in triglycerides, free fatty acids, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol at Weeks 5, 8, 12, and 16
Timeframe: Baseline and Weeks 5, 8, 12, and 16
Change from Baseline in Functional Living Index – Emesis (FLIE) scores at Week 16
Timeframe: Baseline and Week 16
Number of participants with the indicated response to questions on the Hunger, Craving, and Fullness Questionnaire (HCFQ) at Week 16
Timeframe: Week 16
Mean clearance of albiglutide
Timeframe: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27
Mean volume of distribution of albiglutide
Timeframe: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27
Mean absorption rate of albiglutide
Timeframe: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27
Mean half-maximal effective concentration (EC50) of albiglutide for HbA1c and FPG
Timeframe: Weeks 0, 4, 5, 7, 8, 9, 12, 15, 16, 17 18, 20, 23, and 27
Interventions:
Drug: Albiglutide (GSK716155) or exenatide
Enrollment:
361
Observational study model:
Not applicable
Primary completion date:
2008-28-05
Time perspective:
Not applicable
Clinical publications:
Julio Rosenstock, Jane Reusch, Mark Bush, Fred Yang, Murray Stewart, for the Albiglutide Study Group . The Potential of Albiglutide, a Long-Acting GLP-1 Mimetic, in Type 2 Diabetes: a Randomized Controlled Trial Exploring Weekly, Biweekly and Monthly Dosing. Diabetes Care. 2009;32 (10):1880-1886.
Medical condition
Diabetes Mellitus, Type 2
Product
albiglutide
Collaborators
Not applicable
Study date(s)
April 2007 to May 2008
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18 - 75 years
Accepts healthy volunteers
No
- Has type 2 diabetes mellitus as defined by the criteria of the American Diabetes Association and recognized by World Health Organization Expert Committee on the Diagnosis and Classification of Diabetes Mellitus [American Diabetes Association, 2004a] at least three months preceding screening
- Has concurrent type 2 diabetes mellitus therapy: Must be diet and exercise treated; must not have taken antidiabetic medication for at least three months prior to prescreening or Monotherapy with metformin, with a history of a stable dose for at least three months before prescreening (not taking more than one oral antidiabetic agent)
- Has metabolic disease including but not limited to: 1) Diagnosis of type 1 diabetes mellitus, 2) Uncorrected thyroid dysfunction (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least three months prior to screening, and who have a screening thyroid-stimulating hormone within the limits of normal may participate)
- Has qualitative changes in lifestyle that, in the opinion of the investigator, would affect the subject's weight or disease status
Inclusion and exclusion criteria
Inclusion criteria:
- Has type 2 diabetes mellitus as defined by the criteria of the American Diabetes Association and recognized by World Health Organization Expert Committee on the Diagnosis and Classification of Diabetes Mellitus [American Diabetes Association, 2004a] at least three months preceding screening
- Has concurrent type 2 diabetes mellitus therapy: Must be diet and exercise treated; must not have taken antidiabetic medication for at least three months prior to prescreening or Monotherapy with metformin, with a history of a stable dose for at least three months before prescreening (not taking more than one oral antidiabetic agent)
- Has HbA1c level at screening ≥7 and ≤10%
- Is male or female 18 to 75 years of age, inclusive, at screening
- Has body mass index ≥20 and ≤40 kg/m²
- If subject is a smoker, must be able to abstain while in clinic at each visit
- If female, is eligible to enter and participate throughout the study, including the follow-up period: 1) If of nonchildbearing potential (i.e. physiologically incapable of becoming pregnant {tubal ligation}, including any female who is postmenopausal [>1 year without menstrual period]); or, 2) If of childbearing potential, has negative pregnancy tests at screening (serum) and at baseline (urine) and: 3) Has a male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject, or 4) Uses double-barrier methods of contraception; condoms (with spermicide) and intrauterine devices are acceptable, or 5) Uses hormonal contraceptives (oral, depots, patches, etc) with double-barrier methods of contraception as outlined above, or, 6) Abstains from sexual intercourse, or 7) Is with a same-sex partner and does not participate in bisexual activities where there is any risk of pregnancy
- Signs and dates informed consent before any study-related procedures are performed
Exclusion criteria:
- Has metabolic disease including but not limited to: 1) Diagnosis of type 1 diabetes mellitus, 2) Uncorrected thyroid dysfunction (NOTE: subjects with hypothyroidism on a stable dose of thyroid replacement therapy for at least three months prior to screening, and who have a screening thyroid-stimulating hormone within the limits of normal may participate)
- Has qualitative changes in lifestyle that, in the opinion of the investigator, would affect the subject's weight or disease status
- Had previous use of insulin within one month prior to screening, or more than seven total days of insulin treatment within three months prior to screening
- Has clinically significant cardiovascular and/or cerebrovascular disease including, but not limited to: 1) Previous history of stroke or transient ischemic attack, 2) Active, unstable coronary heart disease within the past six months, 3) Documented myocardial infarction within a year prior to screening 4) Any cardiac surgery including percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery within a year prior to screening 5) Unstable angina 6) Clinically significant arrhythmia or valvular heart disease within the past year 7) Congestive heart failure with New York Heart Association Class II to Class IV symptoms. Class I is acceptable. 8) Untreated hypertension, with systolic pressure greater than 160mm Hg and/or diastolic pressure greater than 95mm Hg. 9) ECG exclusion criteria: Heart rate is <40 and >110 beats per minute, PR Interval is <120 and >210msec, QRS duration is <70 and >120msec, QTc interval (Bazett) is >450msec or >480msec with bundle branch block
- Has fasting serum triglycerides ≥800mg/dL or 9mmol/L at screening (Visit 2). Subjects receiving lipid-lowering therapy must have been on the same dose of therapy for the past three months. Fasting is defined as no food/drink for at least eight hours prior to sampling
- If female, is currently lactating, pregnant, or actively trying to become pregnant
- Has significant renal disease as manifested by one or more of the following: 1) Creatinine clearance <60mL/min. (estimated from serum creatinine and demographic data using the modification of diet in renal disease calculation; refer to the SPM/ISFM), 2) Urine albumin excretion ≥500 µg/mL on a urine spot check, 3) Known loss of a kidney either by surgical ablation, injury, or disease
- Has history of significant comorbid diseases active within the last six months (e.g., gastrointestinal disease)
- Has history of pancreatitis within five years prior to randomization
- Has a documented history of chronic or advanced hepatobiliary disease including a history of, or positive laboratory results for, hepatitis at screening (Visit 2), and/or clinically significant hepatic enzyme elevation including: 1) Any two of the following enzymes greater than 1.5 times the upper limit of normal (ULN) value:
- alanine aminotransferase (ALT),
- aspartate aminotransferase (AST),
- alkaline phosphatase (ALP), 2) Any one of the above enzymes two times greater than the ULN value AND total or direct bilirubin >1.5 times the ULN
- Has a history of alcohol or substance abuse within the past year, as determined by the investigator or a positive urine drug screen at screening (Visit 2) or during treatment: 1) Unwilling to refrain from the use of excessive alcohol or illicit drugs and adhere to other protocol-stated restrictions while participating in the study, 2) History of alcohol abuse defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than two units (females). One unit is equivalent to a half-pint of beer or one measure of spirits or one glass of wine, 2) The investigator should exercise their medical judgment to determine if a urine drug screen is indicated
- Is currently taking prohibited concomitant medications listed in Section 6.6.2
- Has clinically significant anemia (i.e., hemoglobin <12.0g/dL or <120.0g/L for males and <11.0g/dL or <110.0g/L for females) or any other abnormal hematological profile that is considered by the investigator to be clinically significant
- Has known allergy to any formulation excipients, or history of drug or other allergy, which, in the opinion of the responsible study physician, contradicts participation
- Received treatment with an investigational drug or participated in any other clinical trial during the previous 30 days
- Has prior use of investigational agents with long half-lives of greater than seven days within the three months prior to screening
- Has any prior use of a GLP-1 analog, including GSK716155
- In the opinion of the investigator, has a risk of noncompliance with study procedures, or cannot read, understand, or complete study-related materials, particularly the informed consent
- Has any concurrent condition or any clinically significant abnormality identified on the screening physical examination, laboratory tests, ECG, including pulmonary, neurological, or inflammatory diseases, which, in the opinion of the investigator, may affect the interpretation of efficacy and safety data, or which otherwise, contraindicates participation in a clinical trial with a new chemical entity
Trial location(s)
Location
GSK Investigational Site
Van Buys, California, United States, 91405
Status
Will Be Recruiting
Location
GSK Investigational Site
San Antonio, Texas, United States, 78205
Status
Will Be Recruiting
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40504
Status
Will Be Recruiting
Location
GSK Investigational Site
Sacramento, California, United States, 95823
Status
Will Be Recruiting
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 8320268
Status
Will Be Recruiting
Location
GSK Investigational Site
Ventura, California, United States, 93003
Status
Will Be Recruiting
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46256
Status
Will Be Recruiting
Location
GSK Investigational Site
Haverhill, Massachusetts, United States, 01831-2451
Status
Will Be Recruiting
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Will Be Recruiting
Location
GSK Investigational Site
Johnson City, Tennessee, United States, 37604
Status
Will Be Recruiting
Location
GSK Investigational Site
Anderson, Indiana, United States, 46011
Status
Will Be Recruiting
Location
GSK Investigational Site
Tallahassee, Florida, United States, 32308
Status
Will Be Recruiting
Location
GSK Investigational Site
Houston, Texas, United States, 77056
Status
Will Be Recruiting
Location
GSK Investigational Site
Jefferson City, Missouri, United States, 65109
Status
Will Be Recruiting
Location
GSK Investigational Site
Chester, Virginia, United States, 23836
Status
Will Be Recruiting
Location
GSK Investigational Site
Gainesville, Florida, United States, 32601
Status
Will Be Recruiting
Location
GSK Investigational Site
Bend, Oregon, United States, 97701
Status
Will Be Recruiting
Location
GSK Investigational Site
Bull Shoals, Arizona, United States, 72619
Status
Will Be Recruiting
Location
GSK Investigational Site
The Woodlands, Texas, United States, 77381
Status
Will Be Recruiting
Location
GSK Investigational Site
Meridian, Idaho, United States, 83642
Status
Will Be Recruiting
Location
GSK Investigational Site
Augusta, Georgia, United States, 30909
Status
Will Be Recruiting
Location
GSK Investigational Site
Palm Harbor, Florida, United States, 34684
Status
Will Be Recruiting
Location
GSK Investigational Site
Springfield, Missouri, United States, 65807
Status
Will Be Recruiting
Location
GSK Investigational Site
Tampa, Florida, United States, 33603
Status
Will Be Recruiting
Location
GSK Investigational Site
Glendale, Arizona, United States, 85306
Status
Will Be Recruiting
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37203
Status
Will Be Recruiting
Location
GSK Investigational Site
North Platte, Nebraska, United States, 69101
Status
Will Be Recruiting
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89106
Status
Will Be Recruiting
Location
GSK Investigational Site
Winter Haven, Florida, United States, 33881
Status
Will Be Recruiting
Location
GSK Investigational Site
Covington, Louisiana, United States, 70433
Status
Will Be Recruiting
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Will Be Recruiting
Location
GSK Investigational Site
Harrisburg, Arkansas, United States, 72432
Status
Will Be Recruiting
Location
GSK Investigational Site
Denver, Colorado, United States, 80220
Status
Will Be Recruiting
Location
GSK Investigational Site
Trumbull, Connecticut, United States, 06611
Status
Will Be Recruiting
Location
GSK Investigational Site
Dallas, Texas, United States, 75230
Status
Will Be Recruiting
Location
GSK Investigational Site
Clarksville, Tennessee, United States, 37043
Status
Will Be Recruiting
Location
GSK Investigational Site
Asheville, North Carolina, United States, 28801
Status
Will Be Recruiting
Location
GSK Investigational Site
Lewisville, Texas, United States, 75067
Status
Will Be Recruiting
Location
GSK Investigational Site
South Bend, Indiana, United States, 46628
Status
Will Be Recruiting
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Will Be Recruiting
Location
GSK Investigational Site
Miami, Florida, United States, 33144
Status
Will Be Recruiting
Location
GSK Investigational Site
Euless, Texas, United States, 76040
Status
Will Be Recruiting
Location
GSK Investigational Site
Harrisburg, Pennsylvania, United States, 17112
Status
Will Be Recruiting
Location
GSK Investigational Site
Winter Park, Florida, United States, 32789
Status
Will Be Recruiting
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30308
Status
Will Be Recruiting
Location
GSK Investigational Site
Toledo, Ohio, United States, 43606
Status
Will Be Recruiting
Location
GSK Investigational Site
Caro, Michigan, United States, 48723
Status
Will Be Recruiting
Location
GSK Investigational Site
Pearland, Texas, United States, 77584
Status
Will Be Recruiting
Location
GSK Investigational Site
Houston, Texas, United States, 77082
Status
Will Be Recruiting
Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Will Be Recruiting
Location
GSK Investigational Site
Madison, Washington, United States, 53717
Status
Will Be Recruiting
Location
GSK Investigational Site
Columbus, Ohio, United States, 43235
Status
Will Be Recruiting
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
Status
Will Be Recruiting
Location
GSK Investigational Site
Concepcion, Región Del Biobio, Chile, 4070038
Status
Will Be Recruiting
Location
GSK Investigational Site
Plantation, Florida, United States, 33317
Status
Will Be Recruiting
Location
GSK Investigational Site
Mobile, Alabama, United States, 36617
Status
Will Be Recruiting
Location
GSK Investigational Site
San Marcos, Texas, United States, 78666
Status
Will Be Recruiting
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44122
Status
Will Be Recruiting
Location
GSK Investigational Site
Midland, Texas, United States, 79707
Status
Will Be Recruiting
Location
GSK Investigational Site
Kalamazoo, Michigan, United States, 49048
Status
Will Be Recruiting
Location
GSK Investigational Site
Billings, Montana, United States, 59101
Status
Will Be Recruiting
Location
GSK Investigational Site
Clearwater, Florida, United States, 33756
Status
Will Be Recruiting
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28227
Status
Will Be Recruiting
Location
GSK Investigational Site
Missouri City, Texas, United States, 77459
Status
Will Be Recruiting
Location
GSK Investigational Site
Grand Forks, North Dakota, United States, 58201
Status
Will Be Recruiting
Location
GSK Investigational Site
Ft. Lauderdale, Florida, United States, 33316
Status
Will Be Recruiting
Location
GSK Investigational Site
Houston, Texas, United States, 77030
Status
Will Be Recruiting
Location
GSK Investigational Site
Huntington Beach, California, United States, 92646
Status
Will Be Recruiting
Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Will Be Recruiting
Location
GSK Investigational Site
Fargo, North Dakota, United States, 58104
Status
Will Be Recruiting
Location
GSK Investigational Site
Loma Linda, California, United States, 92354
Status
Will Be Recruiting
Location
GSK Investigational Site
Houston, Texas, United States, 77070
Status
Will Be Recruiting
Location
GSK Investigational Site
Aurora, Illinois, United States, 60504
Status
Will Be Recruiting
Location
GSK Investigational Site
Torrance, California, United States, 90503
Status
Will Be Recruiting
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68516
Status
Will Be Recruiting
Location
GSK Investigational Site
Garden Grove, California, United States, 92843
Status
Will Be Recruiting
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89128
Status
Will Be Recruiting
Location
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Status
Will Be Recruiting
Location
GSK Investigational Site
Spring, Texas, United States, 77379
Status
Will Be Recruiting
Location
GSK Investigational Site
Castro Valley, California, United States, 94546
Status
Will Be Recruiting
Location
GSK Investigational Site
Marianna, Florida, United States, 32446
Status
Will Be Recruiting
Location
GSK Investigational Site
Evergreen Park, Illinois, United States, 60805
Status
Will Be Recruiting
Location
GSK Investigational Site
Kansas City, Kansas, United States, 66160
Status
Will Be Recruiting
Location
GSK Investigational Site
Tucker, Georgia, United States, 30084
Status
Will Be Recruiting
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Will Be Recruiting
Location
GSK Investigational Site
Los Angeles, California, United States, 90022
Status
Will Be Recruiting
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30338
Status
Will Be Recruiting
Location
GSK Investigational Site
Pharr, Texas, United States, 78577
Status
Will Be Recruiting
Location
GSK Investigational Site
Suwanee, Georgia, United States, 30024
Status
Will Be Recruiting
Location
GSK Investigational Site
Lake Forest, California, United States, 92630
Status
Will Be Recruiting
Location
GSK Investigational Site
La Grange, Illinois, United States, 60525
Status
Will Be Recruiting
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Will Be Recruiting
Location
GSK Investigational Site
Culver City, California, United States, 90232
Status
Will Be Recruiting
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73104
Status
Will Be Recruiting
Location
GSK Investigational Site
Topeka, Kansas, United States, 66606
Status
Will Be Recruiting
Location
GSK Investigational Site
Huntington Park, California, United States, 90255
Status
Will Be Recruiting
Location
GSK Investigational Site
Fullerton, California, United States, 92835
Status
Will Be Recruiting
Location
GSK Investigational Site
Sugar Land, Texas, United States, 77478
Status
Will Be Recruiting
Location
GSK Investigational Site
Tomball, Texas, United States, 77375
Status
Will Be Recruiting
Location
GSK Investigational Site
Omaha, Nebraska, United States, 68152
Status
Will Be Recruiting
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
Status
Will Be Recruiting
Location
GSK Investigational Site
Round Rock, Texas, United States, 78664
Status
Will Be Recruiting
Location
GSK Investigational Site
Houston, Texas, United States, 77006
Status
Will Be Recruiting
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35233
Status
Will Be Recruiting
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37923
Status
Will Be Recruiting
Location
GSK Investigational Site
Oviedo, Florida, United States, 32765
Status
Will Be Recruiting
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Will Be Recruiting
Location
GSK Investigational Site
St. Peters, Missouri, United States, 63376
Status
Will Be Recruiting
Location
GSK Investigational Site
Lacombe, Louisiana, United States, 70433
Status
Will Be Recruiting
Location
GSK Investigational Site
Picayune, Mississippi, United States, 39446
Status
Will Be Recruiting
Location
GSK Investigational Site
Watertown, South Dakota, United States, 57201
Status
Will Be Recruiting
Location
GSK Investigational Site
Bradenton, Florida, United States, 34205
Status
Will Be Recruiting
Location
GSK Investigational Site
Athens, Georgia, United States, 30606
Status
Will Be Recruiting
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27455
Status
Will Be Recruiting
Location
GSK Investigational Site
Mint Hill, North Carolina, United States, 28227
Status
Will Be Recruiting
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30312
Status
Will Be Recruiting
Location
GSK Investigational Site
Cleburne, Texas, United States, 76033
Status
Will Be Recruiting
Location
GSK Investigational Site
Anniston, Alabama, United States, 36207
Status
Will Be Recruiting
Location
GSK Investigational Site
Glens Falls, New York, United States, 12801
Status
Will Be Recruiting
Location
GSK Investigational Site
Libertyville, Illinois, United States, 60048
Status
Will Be Recruiting
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38119
Status
Will Be Recruiting
Location
GSK Investigational Site
Fargo, North Dakota, United States, 58122
Status
Will Be Recruiting
Location
GSK Investigational Site
Searcy, Arkansas, United States, 72143
Status
Will Be Recruiting
Location
GSK Investigational Site
Oak Brook, Illinois, United States, 60523
Status
Will Be Recruiting
Location
GSK Investigational Site
Longview, Texas, United States, 75605
Status
Will Be Recruiting
Location
GSK Investigational Site
Rochester, New York, United States, 14609
Status
Will Be Recruiting
Location
GSK Investigational Site
Perry, Georgia, United States, 31069
Status
Will Be Recruiting
Location
GSK Investigational Site
Decatur, Georgia, United States, 30032
Status
Will Be Recruiting
Location
GSK Investigational Site
Salem, Virginia, United States, 24153
Status
Will Be Recruiting
Location
GSK Investigational Site
Honolulu, Hawaii, United States, 96813
Status
Will Be Recruiting
Location
GSK Investigational Site
Riverside, California, United States, 92506
Status
Will Be Recruiting
Location
GSK Investigational Site
Watseka, Illinois, United States, 60970
Status
Will Be Recruiting
Location
GSK Investigational Site
Rolling Fork, Mississippi, United States, 39159
Status
Will Be Recruiting
Location
GSK Investigational Site
Victorville, California, United States, 92395
Status
Will Be Recruiting
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72211-3733
Status
Will Be Recruiting
Location
GSK Investigational Site
Bismarck, North Dakota, United States, 58504
Status
Will Be Recruiting
Location
GSK Investigational Site
Williamsville, New York, United States, 14221
Status
Will Be Recruiting
Location
GSK Investigational Site
Uniontown, Pennsylvania, United States, 15401
Status
Will Be Recruiting
Location
GSK Investigational Site
Charlotte, North Carolina, United States, 28204
Status
Will Be Recruiting
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32204
Status
Will Be Recruiting
Location
GSK Investigational Site
Manassas, Virginia, United States, 20110
Status
Will Be Recruiting
Location
GSK Investigational Site
Buin, Región Metro De Santiago, Chile, 9500645
Status
Will Be Recruiting
Location
GSK Investigational Site
Columbus, Georgia, United States, 31904
Status
Will Be Recruiting
Location
GSK Investigational Site
Jonesboro, Arizona, United States, 72401
Status
Will Be Recruiting
Location
GSK Investigational Site
LaPorte, Texas, United States, 77571
Status
Will Be Recruiting
Location
GSK Investigational Site
Buffalo, New York, United States, 14209
Status
Will Be Recruiting
Location
GSK Investigational Site
Milan, Tennessee, United States, 38358
Status
Will Be Recruiting
Location
GSK Investigational Site
Reedley, California, United States, 93654
Status
Will Be Recruiting
Location
GSK Investigational Site
Bensalem, Pennsylvania, United States, 19020
Status
Will Be Recruiting
Location
GSK Investigational Site
Redwood City, California, United States, 94062
Status
Will Be Recruiting
Location
GSK Investigational Site
Dubuque, Iowa, United States, 52002
Status
Will Be Recruiting
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Will Be Recruiting
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85032
Status
Will Be Recruiting
Location
GSK Investigational Site
South Bend, Indiana, United States, 46601
Status
Will Be Recruiting
Location
GSK Investigational Site
Morrisville, Pennsylvania, United States, 19067
Status
Will Be Recruiting
Location
GSK Investigational Site
Pasadena, Texas, United States, 77504
Status
Will Be Recruiting
Location
GSK Investigational Site
Chadbourn, North Carolina, United States, 28431
Status
Will Be Recruiting
Location
GSK Investigational Site
Dearborn, Michigan, United States, 48126
Status
Will Be Recruiting
Location
GSK Investigational Site
Huntington Beach, California, United States, 92648
Status
Will Be Recruiting
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-28-05
Actual study completion date
2008-28-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
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