Status:
COMPLETED
Eight-Weeks Of Treatment With Talnetant In Subjects With Irritable Bowel Syndrome (IBS)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Irritable Colon
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the effectiveness and safety of the investigational drug talnetant in treating subjects with irritable bowel syndrome (IBS).
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
741 Patients enrolled
Trial Details
Trial ID
NCT00101985
Start Date
October 1 2004
End Date
July 1 2005
Last Update
April 13 2015
Active Locations (135)
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1
GSK Investigational Site
Chandler, Arizona, United States, 85224
2
GSK Investigational Site
Phoenix, Arizona, United States, 85016
3
GSK Investigational Site
North Little Rock, Arkansas, United States, 72117
4
GSK Investigational Site
Carmichael, California, United States, 95608