Eight-Weeks Of Treatment With Talnetant In Subjects With Irritable Bowel Syndrome (IBS)

Study Overview
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Brief Summary
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This study will evaluate the effectiveness and safety of the investigational drug talnetant in treating subjects with irritable bowel syndrome (IBS).

Official Title
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An Eight-week, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate Efficacy and Safety of Talnetant in Subjects With Irritable Bowel Syndrome

Conditions
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Irritable Colon

Intervention / Treatment
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* Drug: talnetant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: talnetant|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, Quality of Life, Irritable bowel syndrome, SB223412, Qol