Last updated: 07/14/2020 15:20:15
Eight-Weeks Of Treatment With Talnetant In Subjects With Irritable Bowel Syndrome (IBS)
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An Eight-week, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate efficacy and safety of talnetant in subjects with irritable bowel syndrome
Trial description: This study will evaluate the effectiveness and safety of the investigational drug talnetant in treating subjects with irritable bowel syndrome (IBS).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Determine whether talnetant provided adequate relief from IBS pain and discomfort for at least one of three talnetant dose groups compared with placebo and to determine the safety and tolerability of talnetant in subjects with IBS.
Timeframe: Week 5 through Week 8
Secondary outcomes:
- Explore response among subgroups IBS. - Evaluate positive treatment effects within bowel subgroups. - Compare treatment groups for global improvement of IBS symptoms. - Improvement of IBS pain or discomfort, Quality of Life.
Timeframe: Week 5 through Week 8.
Interventions:
Enrollment:
741
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Irritable Colon
Product
talnetant
Collaborators
Not applicable
Study date(s)
October 2004 to July 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Subjects will be required to conduct self-assessments of their IBS symptoms using a touch-tone telephone system for the duration of the study (15 weeks).
- Must be diagnosed with IBS consistent with the Rome II criteria.
- Self-assessment of no stool for 7 days during the two-week screening phase.
- Clinically significant abnormal laboratory tests.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects will be required to conduct self-assessments of their IBS symptoms using a touch-tone telephone system for the duration of the study (15 weeks).
- Must be diagnosed with IBS consistent with the Rome II criteria.
- Must have normal results from a colonic procedure within 2 years of randomization.
- Must have conducted self-assessments on at least 12 days and have a documented average IBS pain or discomfort score of greater than or equal to 1.5 during the two-week screening phase.
Exclusion criteria:
- Self-assessment of no stool for 7 days during the two-week screening phase.
- Clinically significant abnormal laboratory tests.
- Current evidence or history of various conditions, comorbidities, or surgeries such as Irritable Bowel Disease (IBD), gastrointestinal surgeries, and diverticulitis.
- Inability to use the touch-tone telephone system.
- Hypersensitivity to quinolone antibiotics or quinolone derivatives.
- Diagnosis of a psychiatric disorder within the past 2 years and not on a stable dose of medication for at least 6 months.
- Women who are pregnant, breast feeding, or planning to become pregnant during the study. Permitted medications: The subject is allowed to take any of the following medications, provided they maintain a stable dose for at least 30 days prior to the Screening visit and throughout the remainder of the study:
- Antidepressants, except REMERON
- Antihypercholesterolemics
- Iron supplements
- Bulking agents
- Fiber supplement
- Thyroid replacement therapy (levothyroxine)
- Antipsychotics
- Cox-2 inhibitors (CELEBREX) Prohibited medications: Subjects must stop taking any medications they are taking to treat their IBS symptoms and must not have taken any of the prohibited medications at least 7 days prior to the Screening visit and must remain off these medications for the duration of the study.
- Anticholinergics (dicyclomine, hyoscyamine, propantheline)
- Cholinomimetic (bethanechol, pyridostigmine, tacrine, physostigmine)
- All narcotics (morphine, codeine, TYLENOL #3, propoxyphene, either alone or in combination)
- Tramadol hydrochloride (ULTRAM)
- Colchicine
- Orlistat (XENICAL)
- Misoprostol, alone or in combination (ARTHROTEC, CYTOTEC)
- 5-HT3 receptor antagonists (ondansetron, tropisetron, dolasetron, granisetron, mirtazapine, cilansetron, alosetron)
- Tegaserod (ZELNORM)
- Gabapentin
- Lupron
- Antacids containing magnesium or aluminium
- Antidiarrheal agents
- Bismuth compounds
- Prokinetic agents (cisapride, metoclopramide)
- Sulfasalazine
- Laxatives
- Cholestyramine
Trial location(s)
Location
GSK Investigational Site
Garden Grove, California, United States, 92840
Status
Study Complete
Location
GSK Investigational Site
Blackwood, New Jersey, United States, 08012
Status
Study Complete
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27403
Status
Study Complete
Location
GSK Investigational Site
Florence, Kentucky, United States, 41042
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Torrington, Connecticut, United States, 06790
Status
Study Complete
Location
GSK Investigational Site
Chandler, Arizona, United States, 85224
Status
Study Complete
Location
GSK Investigational Site
Boulder, Colorado, United States, 80304
Status
Study Complete
Location
GSK Investigational Site
Fishkill, New York, United States, 12524
Status
Study Complete
Location
GSK Investigational Site
Newark, Delaware, United States, 19713
Status
Study Complete
Location
GSK Investigational Site
Northwood, Middlesex, United Kingdom, HA6 2RN
Status
Study Complete
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
Status
Study Complete
Location
GSK Investigational Site
Spring Valley, California, United States, 91978
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14609
Status
Study Complete
Location
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
Status
Study Complete
Location
GSK Investigational Site
Bedford Park, South Australia, Australia, 5042
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40202
Status
Study Complete
Location
GSK Investigational Site
Newtown, New South Wales, Australia, 2042
Status
Terminated/Withdrawn
Location
GSK Investigational Site
San Antonio, Texas, United States, 78209
Status
Study Complete
Location
GSK Investigational Site
Riverside, Illinois, United States, 60546
Status
Study Complete
Location
GSK Investigational Site
Bronx, New York, United States, 10461
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 1J5
Status
Study Complete
Location
GSK Investigational Site
Slidell, Louisiana, United States, 70458
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Spring Hill, Queensland, Australia, 4000
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02118
Status
Terminated/Withdrawn
Location
GSK Investigational Site
North Little Rock, Arkansas, United States, 72117
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15224
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Portergate, Sheffield, United Kingdom, S11
Status
Study Complete
Location
GSK Investigational Site
Chaska, Minnesota, United States, 55318
Status
Study Complete
Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Study Complete
Location
GSK Investigational Site
St. Joseph, Michigan, United States, 49085
Status
Study Complete
Location
GSK Investigational Site
Rockford, Illinois, United States, 61107
Status
Study Complete
Location
GSK Investigational Site
East Syracuse, New York, United States, 13057
Status
Study Complete
Location
GSK Investigational Site
Roseville, California, United States, 95661
Status
Study Complete
Location
GSK Investigational Site
Carmichael, California, United States, 95608
Status
Study Complete
Location
GSK Investigational Site
Bristol, Connecticut, United States, 06010
Status
Terminated/Withdrawn
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33707
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14607
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28412
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Greer, South Carolina, United States, 29651
Status
Study Complete
Location
GSK Investigational Site
Silver Spring, Maryland, United States, 20901
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Newtown, Pennsylvania, United States, 18940
Status
Study Complete
Location
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Status
Study Complete
Location
GSK Investigational Site
Salisbury, Massachusetts, United States, 01952
Status
Study Complete
Location
GSK Investigational Site
Blackpool, Lancashire, United Kingdom, FY2 9RS
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Concord, California, United States, 94520
Status
Study Complete
Location
GSK Investigational Site
St. Petersburg, Florida, United States, 33709
Status
Study Complete
Location
GSK Investigational Site
Lincoln, Nebraska, United States, 68503
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46237
Status
Study Complete
Location
GSK Investigational Site
Pointe-Claire, Québec, Canada, H9R 4S3
Status
Study Complete
Location
GSK Investigational Site
Chesterfield, Michigan, United States, 48047
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
Status
Study Complete
Location
GSK Investigational Site
Phoenix, Arizona, United States, 85016
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90506
Status
Study Complete
Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Study Complete
Location
GSK Investigational Site
Centennial, Colorado, United States, 80112
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Springfield, Massachusetts, United States, 01107
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Akron, Ohio, United States, 44310
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Eugene, Oregon, United States, 97401
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22911
Status
Study Complete
Location
GSK Investigational Site
Concord, New South Wales, Australia, 2139
Status
Study Complete
Location
GSK Investigational Site
Stamford, Connecticut, United States, 06905
Status
Study Complete
Location
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2606
Status
Study Complete
Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Study Complete
Location
GSK Investigational Site
Portland, Oregon, United States, 97225
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38120
Status
Study Complete
Location
GSK Investigational Site
Great Neck, New York, United States, 11021
Status
Study Complete
Location
GSK Investigational Site
SOMERSET WEST, South Africa, 7130
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Sainte Jerome, Québec, Canada, J7Z 5T3
Status
Study Complete
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38119
Status
Study Complete
Location
GSK Investigational Site
Chattanooga, Tennessee, United States, 37404
Status
Study Complete
Location
GSK Investigational Site
Blackpool, Lancashire, United Kingdom, FY4 3AD
Status
Study Complete
Location
GSK Investigational Site
Port Lincoln, South Australia, Australia, 5606
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30328
Status
Study Complete
Location
GSK Investigational Site
Christiansburg, Virginia, United States, 24073
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lacey, Washington, United States, 98516
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2005-21-07
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
Participate in clinical trial
Access to clinical trial data by researchers
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