Last updated: 11/04/2018 09:48:01
Intravenous And Oral Casopitant (GW679769) For The Prevention Of Chemotherapy Induced Nausea And Vomiting
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Phase III, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group Study of the Safety and Efficacy of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist Casopitant (GW679769) in Combination with Ondansetron and Dexamethasone for the Prevention of Nausea
Trial description: This is a Phase III trial designed to demonstrate that casopitant (GW679769) plus dexamethasone and ondansetron is more effective in the prevention of vomiting than dexamethasone and ondansetron alone following the administration of moderately emetogenic chemotherapy.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of participants who achieved a complete response over the first 120 hours following the initiation of their first cycle of an anthracycline and cyclophosphamide containing MEC regimen
Timeframe: Overall phase (0-120 Hours) of Cycle 1
Secondary outcomes:
Number of participants who achieved a complete response during the acute (0-24 hours) and the delayed (24-120 hours) phase following the first cycle of MEC.
Timeframe: Acute phase (0-24 hours) and delayed phase (24-120 hours) of Cycle 1
Number of participants who achieved a complete response during overall (0-120 hours) phase following the second cycle of MEC
Timeframe: Overall phase (0-120 Hours) of Cycle 2
Number of participants who achieved a complete response during overall (0-120 hours) phase following the third cycle of MEC
Timeframe: Overall phase (0-120 hours) of Cycle 3
Number of participants who achieved a complete response during overall (0-120 hours) phase following the fourth cycle of MEC
Timeframe: Overall phase (0-120 hours) of Cycle 4
Maximum nausea score (MNS) as assessed by a Visual Analogue Scale (VAS) during the acute (0-24 hours) phase
Timeframe: Acute phase (0-24 hours)
MNS as assessed by a VAS during the delayed (24-120 hours) phase
Timeframe: Delayed phase (24-120 hours)
MNS as assessed by a VAS over the first 120 hours
Timeframe: Overall phase (0-120 hours)
Number of participants with time to first antiemetic rescue medication use during the 120 hour assessment phase of each study cycle
Timeframe: Overall phase (0-120 hour) of each cycle
Number of participants with time to first emetic event (vomiting/retching) during the 120 hour assessment phase of each study cycle
Timeframe: Overall phase (0 to 120 hour) of each cycle
Number of participants who required rescue medication over 0-120 hours following Cycle 1 of MEC
Timeframe: Overall phase (0-120 hours) following Cycle 1 of MEC
Number of participants who experienced vomiting/retching over the first 120 hours, during the acute phase (0-24 hours) and the delayed (24-120 hours) phase following Cycle 1 of MEC
Timeframe: Acute phase (0-24 hours), delayed phase (24-120 hours) and Overall phase (0-120 hours) following Cycle 1 of MEC
Number of participants who reported significant nausea (SN) over the first 120 hours, during the acute phase (0-24 hours) and the delayed (24-120 hours) phase following Cycle 1 of MEC
Timeframe: Acute phase (0-24 hours), delayed phase (24-120 hours) and Overall phase (0-120 hours) following Cycle 1 of MEC
Number of participants who reported nausea over the first 120 hours, during the acute phase (0-24 hours) and the delayed (24-120 hours) phase following Cycle 1 of MEC
Timeframe: Acute phase (0-24 hours), delayed phase (24-120 hours) and Overall phase (0-120 hours) following Cycle 1 of MEC
Number of participants who achieved complete protection (CP) over the first 120 hours, during the acute phase (0-24 hours) and the delayed (24-120 hours) phase following Cycle 1 of MEC
Timeframe: Acute phase (0-24 hours), delayed phase (24-120 hours) and Overall phase (0-120 hours) following Cycle 1 of MEC
Number of participants who achieved total control (TC) over the first 120 hours, during the acute phase (0-24 hours) and the delayed (24-120 hours) phase following Cycle 1 of MEC
Timeframe: Acute phase (0-24 hours), delayed phase (24-120 hours) and Overall phase (0-120 hours) following Cycle 1 of MEC
The impact on participants daily life activities for the first 120 hours as assessed by the Functional Living Index-Emesis (FLIE) questionnaire
Timeframe: Overall phase (0-120 hours)
Participant satisfaction (PS) with the prophylactic antiemetic regimens, and the willingness of participants (WP) to use the same treatment during future chemotherapy, assessed by the PS\WP in the Participant Diary over the first 120 hours
Timeframe: Overall phase (0-120 hours)
Number of participants with nausea as assessed by a categorical scale over the first 120 hours during the acute phase (0-24 hours) and the delayed (24-120 hours) phase
Timeframe: Acute phase (0-24 hours), delayed phase (24-120 hours) and overall phase (0-120 hours)
Number of participants with adverse events (AE) and serious adverse events (SAE)
Timeframe: Upto Day 17 of Cycle 1
Number of participants with chemistry grade shifts from Baseline to toxicity grade 3 and 4
Timeframe: Day 1, Day 6-10 and End of cycle visit (Day 17) for Cycle 1-4
Number of participants with hematology toxicity grade shifts from Baseline to toxicity grade 3 and 4
Timeframe: Day 1, Day 6-10 and End of cycle visit (Day 17) for Cycle 1-4
Summary of vital signs-systolic blood pressure (SBP) and diastolic blood pressure (DBP)
Timeframe: Day 1 and End of cycle visit (Day 17) for Cycle 1-4 and Day 6-10 for Cycle 1
Summary of vital sign-heart rate (HR)
Timeframe: Day 1 and End of cycle visit (Day 17) for Cycle 1-4 and Day 6-10 for Cycle 1
Summary of vital sign respiration rate (RR)
Timeframe: Day 1 and End of cycle visit (Day 17) for Cycle 1-4 and Day 6-10 for Cycle 1
Number of participants with abnormal electrocardiogram (ECG) findings defined by clinical significance
Timeframe: Day 6-10, End of cycle (for cycle 1) and at follow-up 3-month
Interventions:
Enrollment:
1933
Primary completion date:
2007-29-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Herrstedt J, Apornwirat W, Shaharyar A, Aziz Z, Roila F, Van Belle S, Russo MW, Levin J, Ranganathan S, Guckert M, Grunberg SM. Phase III trial of casopitant, a novel neurokinin-1 receptor antagonist, for the prevention of nausea and vomiting in patients receiving moderately emetogenic chemotherapy. 2009;27(32): 5363-9.
Medical condition
Nausea and Vomiting, Chemotherapy-Induced
Product
casopitant, ondansetron
Collaborators
Not applicable
Study date(s)
July 2006 to August 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
- Subject understands the nature and purpose of this study and the study procedures and has signed an informed consent form for this study to indicate this understanding.
- Has previously received cytotoxic chemotherapy. A history of previous biological or hormonal therapy will be permitted.
- Is a female subject who is pregnant or lactating.
Inclusion and exclusion criteria
Inclusion criteria:
- A subject will be considered eligible for inclusion in this study only if all of the following criteria apply:
- Subject understands the nature and purpose of this study and the study procedures and has signed an informed consent form for this study to indicate this understanding.
- At least 18 years of age.
- Is scheduled to receive their first course of an anthracycline and cyclophosphamide containing moderately emetogenic chemotherapy regimen for the treatment of a solid malignant tumor as outlined in Section 8.1.1.
- Has an ECOG performance status of 0, 1, or 2.
- Hematologic and metabolic status must be adequate for receiving a moderately emetogenic regimen and meet the following criteria: ·Total Neutrophils ≥ 1500/mm³(Standard units : ≥1.5 x 10^9/L) ·Platelets ≥ 100,000/mm³ (Standard units: ≥100.0 x 10^9/L) ·Bilirubin ≤ 1.5 x ULN ·Liver enzymes must be below the following limits: o Without known liver metastases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 x upper limit of normal. o With known liver metastases: AST and/or ALT ≤ 5.0 x upper limit of normal.
- Is willing and able to complete daily components of the subject diary for each study cycle.
- Women of childbearing potential; must commit to consistent and correct use of an acceptable method of birth control; GSK acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of a physician, are as follows: a.Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal. For purposes of this study, postmenopausal is defined as one year without menses) b.child-bearing potential: must have a negative serum pregnancy test result or negative urine dipstick pregnancy test within 24 hours prior to the first dose of investigational product of Cycle 1, Day 1 and agrees to one of the following: ·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 ·oral contraceptives (e.g., oral, injectable, or implantable) with double-barrier method of contraception consisting of spermicide with either condom or diaphragm for a period after the trial to account for potential drug interaction (minimum of six weeks) ·double-barrier method of contraception consisting of spermicide with either condom or diaphragm ·intra-uterine device (IUD) with a documented failure rate of less than 1% per year ·complete abstinence from intercourse for two weeks before exposure to the investigational product throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of three days), ·if subjects indicate they will remain abstinent during the period described above, they must agree to follow GSK guidelines for the consistent and correct use of an acceptable method of birth control should they become sexually active.
Exclusion criteria:
- Has previously received cytotoxic chemotherapy. A history of previous biological or hormonal therapy will be permitted.
- Is a female subject who is pregnant or lactating.
- Has received radiation therapy to the brain, abdomen, or pelvis in the ten days prior to the first dose of study medication or casopitant investigational product and/or will receive radiation therapy to the brain, abdomen, or the pelvis in the six days following the first dose of study medication (ZOFRAN and dexamethasone) or casopitant investigational product.
- Is scheduled to receive taxane therapy during cycle 1. Note that subjects will be permitted to receive taxane therapy in conjunction with one of the allowed MEC regimens during subsequent cycles.
- Has experienced emesis (i.e., vomiting and/or retching) or clinically significant nausea in the 24 hours preceding the first dose of study medication or casopitant investigational product.
- Has a known central nervous system primary or metastatic malignancy, unless successfully treated with excision or radiation and has been medically stable for at least 1 week prior to receiving the first dose of study medication or casopitant investigational product.
- Has history of documented peptic ulcer disease (via endoscopy or x-ray), active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, or any uncontrolled medical condition (other than malignancy) which in the opinion of the Investigator may confound the results of the study, represent another potential etiology for emesis and nausea (other than CINV) or pose an unwarranted risk to the subject.
- Has a known hypersensitivity or contraindication to ZOFRAN, another 5-HT3 receptor antagonist, dexamethasone, or any component of casopitant.
- Has previously received an NK-1 receptor antagonist.
- Received an investigational drug in the previous 30 days or is scheduled to receive any investigational drug other than casopitant during the study period.
- Has taken/received any medication of moderate or high emetogenic potential within the 48 hours prior to the first dose of study medication or casopitant investigational product. Opioid narcotics for cancer pain will be permitted if the subject has been on a stable dose and has not experienced emesis or nausea from the narcotics.
- Has taken/received any medication with known or potential antiemetic activity within the 24-hour period prior to receiving study drug. This includes, but is not limited to: ·5-HT3 receptor antagonists (e.g., ondansetron, granisetron, dolasetron, tropisetron, ramosetron). Palonestron is not permitted within 7 days prior to administration of investigational product. ·benzamide / benzamide derivatives (e.g., metoclopramide, alizapride) ·benzodiazepines (except if the subject is receiving such medication for sleep or anxiety and has been on a stable dose for at least seven days prior to the first dose of casopitant investigational product; however, lorazepam is prohibited 24 hours prior to receiving study drug regardless of reason for use) ·phenothiazines (e.g., prochlorperazine, promethazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine) ·butyrophenone (e.g., haloperidol, droperidol) ·corticosteroids (e.g., dexamethasone, methylprednisolone; with the exception of topical steroids for skin disorders, inhaled steroids for respiratory disorders, and prophylactic treatment for taxane therapy during subsequent cycles) ·anticholinergics (e.g., scopolamine, with the exception of inhaled anticholingerics for respiratory disorders e.g., ipratropium bromide) ·antihistamines (e.g., cyclizine, hydroxyzine, diphenhydramine), except for prophylactic use for taxane therapy during cycle 2-4 ·domperidone ·cannabinoids ·mirtazpine ·olanzapine
- Has taken/received strong or moderate inhibitors of CYP3A4 and CYP3A5 for a specified period prior to administration of casopitant investigational product (see Section 8.2.1 “Inhibitors of CYP3A4 and CYP3A5”)
- Has taken/received inducers of CYP3A4 and CYP3A5 within fourteen days prior to the administration of casopitant investigational product. (see Section 8.2.2 “Inducers of CYP3A4 and CYP3A5”)
- Is taking the anti-diabetic agent repaglinide or the diuretic torsemide. Investigators are advised to exercise caution if including patients taking the anti-diabetic agents rosiglitazone or pioglitazone, or antimalarial agents such as chloroquine and amodiaquine, as the metabolite of casopitant is a potential inhibitor of CYP2C8 (See Section 8.2.3 “Substrates for CYP2C8” and Section 8.4 “Necessary Caution with CYP2C8 Substrates”).
- Is currently taking or plans to take the any of the following CYP3A4 substrates: astemizole, cisapride, pimozide, terfenadine.
Trial location(s)
Location
GSK Investigational Site
Galesburg, Illinois, United States, 61401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50677
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sumter, South Carolina, United States, 29150
Status
Study Complete
Location
GSK Investigational Site
Durham, North Carolina, United States, 27710
Status
Study Complete
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33328
Status
Study Complete
Location
GSK Investigational Site
Hershey, Pennsylvania, United States, 17033
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saxonwold, Johannesburg, South Africa, 2196
Status
Study Complete
Location
GSK Investigational Site
Montreal, Québec, Canada, H3T 1E2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Augusta, Georgia, United States, 30912
Status
Study Complete
Location
GSK Investigational Site
Charlottetown, Prince Edward Island, Canada, C1A 8T5
Status
Study Complete
Location
GSK Investigational Site
Bismarck, North Dakota, United States, 58501
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Columbus, Georgia, United States, 31904
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20010
Status
Study Complete
Location
GSK Investigational Site
Poway, California, United States, 92064
Status
Study Complete
Location
GSK Investigational Site
Fayetteville, Arkansas, United States, 72703
Status
Study Complete
Location
GSK Investigational Site
Great Falls, Montana, United States, 59405
Status
Study Complete
Location
GSK Investigational Site
Corpus Christi, Texas, United States, 78412
Status
Study Complete
Location
GSK Investigational Site
Burlington, Vermont, United States, 05401
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 22767
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Alexandria, Louisiana, United States, 71301
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hot Springs, Arkansas, United States, 71913
Status
Study Complete
Location
GSK Investigational Site
Denville, New Jersey, United States, 07834
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greenfield Park, Québec, Canada, J4V 2H1
Status
Study Complete
Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Study Complete
Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Study Complete
Location
GSK Investigational Site
Bethlehem, Pennsylvania, United States, 18015
Status
Study Complete
Location
GSK Investigational Site
Baton Rouge, Louisiana, United States, 70809
Status
Study Complete
Location
GSK Investigational Site
Chelmsford, Essex, United Kingdom, CM1 7ET
Status
Study Complete
Location
GSK Investigational Site
Ostrava - Poruba, Czech Republic, 708 52
Status
Study Complete
Location
GSK Investigational Site
New Port Richey, Florida, United States, 34652
Status
Study Complete
Location
GSK Investigational Site
Glendale, Arizona, United States, 85304
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Tamarac, Florida, United States, 33321
Status
Study Complete
Location
GSK Investigational Site
Norwich, Connecticut, United States, 06360
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Clinton Township, Michigan, United States, 48038
Status
Study Complete
Location
GSK Investigational Site
San Diego, California, United States, 92121
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35233
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Mt. Pleasant, South Carolina, United States, 29464
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21237
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Fort Lauderdale, Florida, United States, 33316
Status
Study Complete
Location
GSK Investigational Site
Worcester, Massachusetts, United States, 01608
Status
Study Complete
Location
GSK Investigational Site
Sayre, Pennsylvania, United States, 18840
Status
Study Complete
Location
GSK Investigational Site
West Palm Beach, Florida, United States, 33401
Status
Study Complete
Location
GSK Investigational Site
Concord, California, United States, 94520
Status
Study Complete
Location
GSK Investigational Site
Boynton Beach, Florida, United States, 33435
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Everett, Washington, United States, 98201
Status
Study Complete
Location
GSK Investigational Site
Spokane, Washington, United States, 99204
Status
Study Complete
Location
GSK Investigational Site
St. Joseph, Michigan, United States, 49085
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Somerville, New Jersey, United States, 08876
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Study Complete
Location
GSK Investigational Site
Los Angeles, California, United States, 90057
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87109
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sparta, New Jersey, United States, 07871
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Newark, New Jersey, United States, 07112
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Richardson, Texas, United States, 75080
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Skokie, Illinois, United States, 60076
Status
Study Complete
Location
GSK Investigational Site
Wuerselen, Nordrhein-Westfalen, Germany, 52146
Status
Study Complete
Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Study Complete
Location
GSK Investigational Site
Greenbrae, California, United States, 94904-2007
Status
Study Complete
Location
GSK Investigational Site
Hazard, Kentucky, United States, 41701
Status
Study Complete
Location
GSK Investigational Site
Moncton, New Brunswick, Canada, E1C 8X3
Status
Study Complete
Location
GSK Investigational Site
Jena, Thueringen, Germany, 07743
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000KZE
Status
Study Complete
Location
GSK Investigational Site
Hattiesburg, Mississippi, United States, 39401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Free Soil, Michigan, United States, 49411
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Billings, Montana, United States, 59101
Status
Study Complete
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69126
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Inverness, Florida, United States, 34452
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40503
Status
Study Complete
Location
GSK Investigational Site
Pittsfield, Massachusetts, United States, 01201
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45122
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Soquel, California, United States, 95073
Status
Terminated/Withdrawn
Location
GSK Investigational Site
London, United Kingdom, EC1A 7BE
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Huntington, West Virginia, United States, 25701
Status
Study Complete
Location
GSK Investigational Site
Mason City, Iowa, United States, 50401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35209
Status
Study Complete
Location
GSK Investigational Site
Tupelo, Mississippi, United States, 38801
Status
Study Complete
Location
GSK Investigational Site
Buffalo, New York, United States, 14215
Status
Study Complete
Location
GSK Investigational Site
Logan, Utah, United States, 84341
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21229-5299
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Evansville, Indiana, United States, 47713
Status
Study Complete
Location
GSK Investigational Site
Jefferson City, Missouri, United States, 65109
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Huntington, West Virginia, United States, 25705
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1425BGV
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lawrenceville, Georgia, United States, 30045
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 20357
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7N 4H4
Status
Study Complete
Location
GSK Investigational Site
Athlone Park, Amanzimtoti, South Africa, 4126
Status
Study Complete
Location
GSK Investigational Site
Terre Haute, Indiana, United States, 47804
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Brooksville, Florida, United States, 34613
Status
Study Complete
Location
GSK Investigational Site
Rolla, Missouri, United States, 65401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1405CUB
Status
Study Complete
Location
GSK Investigational Site
Corpus Christi, Texas, United States, 78463-3069
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 4E6
Status
Study Complete
Location
GSK Investigational Site
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
La Verne, California, United States, 91750
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Centralia, Illinois, United States, 62801
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53717
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93710
Status
Terminated/Withdrawn
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
Study complete
Actual primary completion date
2007-29-08
Actual study completion date
2007-29-08
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
Additional information
Not applicable
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