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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00101985

Purpose

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

Condition	Intervention	Phase
Irritable Bowel Syndrome (IBS)	Drug: talnetant	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Drug Information available for: SB 223412

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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:

- 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.

Estimated Enrollment:	670
Study Start Date:	October 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00101985

Show 123 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	223412/068
Study First Received:	January 18, 2005
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00101985 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

IBS
SB223412
Qol
Quality of Life
Irritable bowel syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Digestive System Diseases
Gastrointestinal Diseases
Syndrome

Colonic Diseases
Irritable Bowel Syndrome
Intestinal Diseases
Colonic Diseases, Functional

ClinicalTrials.gov processed this record on February 08, 2010