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
- 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).
Inclusion and exclusion criteria
Inclusion 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
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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
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