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

Completed · Phase 2

Conditions studied: Irritable Colon

In brief

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

Key facts

Study ID

NCT00101985

Run by

GlaxoSmithKline

People needed

741

Starts

2004-10-01

Expected to finish

2005-07-01

Last updated by the study team

2015-04-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — North Little Rock, Arkansas, United States
• GSK Investigational Site — Carmichael, California, United States
• GSK Investigational Site — Concord, California, United States
• GSK Investigational Site — Garden Grove, California, United States
• GSK Investigational Site — Orange, California, United States
• GSK Investigational Site — Roseville, California, United States
• GSK Investigational Site — Spring Valley, California, United States
• GSK Investigational Site — Torrance, California, United States
• GSK Investigational Site — Boulder, Colorado, United States
• GSK Investigational Site — Centennial, Colorado, United States
• GSK Investigational Site — Wheat Ridge, Colorado, United States
• GSK Investigational Site — Bristol, Connecticut, United States
• GSK Investigational Site — Stamford, Connecticut, United States
• GSK Investigational Site — Torrington, Connecticut, United States
• GSK Investigational Site — Newark, Delaware, United States
• GSK Investigational Site — DeLand, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — St. Petersburg, Florida, United States
• GSK Investigational Site — St. Petersburg, Florida, United States
• GSK Investigational Site — Atlanta, Georgia, United States
• GSK Investigational Site — Riverside, Illinois, United States
• GSK Investigational Site — Rockford, Illinois, United States
• GSK Investigational Site — Indianapolis, Indiana, United States
• GSK Investigational Site — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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