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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Irritable Colon

Treatments

Drug: talnetant

Study type

Interventional

Funder types

Industry

Identifiers

NCT00101985

223412/068

Details and patient eligibility

About

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

Enrollment

741 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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