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

Irritable Colon Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00101985
• Other study ID #: 223412/068
• Status: Completed
• Phase: Phase 2
• First received: January 18, 2005
• Last updated: April 10, 2015
• Start date: October 2004
• Est. completion date: July 2005

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 741
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Irritable Colon

Intervention

Drug:
• talnetant

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Adelaide	South Australia
Australia	GSK Investigational Site	Bedford Park	South Australia
Australia	GSK Investigational Site	Box Hill	Victoria
Australia	GSK Investigational Site	Concord	New South Wales
Australia	GSK Investigational Site	Fitzroy	Victoria
Australia	GSK Investigational Site	Garran	Australian Capital Territory
Australia	GSK Investigational Site	Kippa Ring	Queensland
Australia	GSK Investigational Site	Malvern	Victoria
Australia	GSK Investigational Site	Melbourne	Victoria
Australia	GSK Investigational Site	Newtown	New South Wales
Australia	GSK Investigational Site	Port Lincoln	South Australia
Australia	GSK Investigational Site	Spring Hill	Queensland
Canada	GSK Investigational Site	Edmonton	Alberta
Canada	GSK Investigational Site	Halifax	Nova Scotia
Canada	GSK Investigational Site	Mississauga	Ontario
Canada	GSK Investigational Site	Montreal	Quebec
Canada	GSK Investigational Site	Pointe-Claire	Quebec
Canada	GSK Investigational Site	Quebec
Canada	GSK Investigational Site	Sainte Jerome	Quebec
Canada	GSK Investigational Site	Sainte-Foy	Quebec
Canada	GSK Investigational Site	Saskatoon	Saskatchewan
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Sherbrooke	Quebec
Canada	GSK Investigational Site	Sudbury	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Truro	Nova Scotia
France	GSK Investigational Site	Caen
France	GSK Investigational Site	Clermont-Ferrand Cedex
France	GSK Investigational Site	Grenoble Cedex
France	GSK Investigational Site	Issoire
France	GSK Investigational Site	Marseille
France	GSK Investigational Site	Miramas
France	GSK Investigational Site	Nice
France	GSK Investigational Site	Vitry sur Seine
Germany	GSK Investigational Site	Bad Segeberg	Schleswig-Holstein
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Chemnitz	Sachsen
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Netherlands	GSK Investigational Site	Stadskanaal
South Africa	GSK Investigational Site	Claremont
South Africa	GSK Investigational Site	N1 City
South Africa	GSK Investigational Site	Parktown
South Africa	GSK Investigational Site	Somerset West
Spain	GSK Investigational Site	Badalona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Madrid
Spain	GSK Investigational Site	Oviedo
Spain	GSK Investigational Site	Unknown
Sweden	GSK Investigational Site	Göteborg
Sweden	GSK Investigational Site	Nacka
Sweden	GSK Investigational Site	Stockholm
Sweden	GSK Investigational Site	Stockholm
United Kingdom	GSK Investigational Site	Blackpool	Lancashire
United Kingdom	GSK Investigational Site	Blackpool	Lancashire
United Kingdom	GSK Investigational Site	Leeds
United Kingdom	GSK Investigational Site	Northwood	Middlesex
United Kingdom	GSK Investigational Site	Portergate, Sheffield
United States	GSK Investigational Site	Akron	Ohio
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Austin	Texas
United States	GSK Investigational Site	Blackwood	New Jersey
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Boulder	Colorado
United States	GSK Investigational Site	Bristol	Connecticut
United States	GSK Investigational Site	Bristol	Tennessee
United States	GSK Investigational Site	Bronx	New York
United States	GSK Investigational Site	Carmichael	California
United States	GSK Investigational Site	Centennial	Colorado
United States	GSK Investigational Site	Chandler	Arizona
United States	GSK Investigational Site	Charlottesville	Virginia
United States	GSK Investigational Site	Chaska	Minnesota
United States	GSK Investigational Site	Chattanooga	Tennessee
United States	GSK Investigational Site	Chesterfield	Michigan
United States	GSK Investigational Site	Christiansburg	Virginia
United States	GSK Investigational Site	Concord	California
United States	GSK Investigational Site	Deland	Florida
United States	GSK Investigational Site	East Syracuse	New York
United States	GSK Investigational Site	El Paso	Texas
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Fishkill	New York
United States	GSK Investigational Site	Florence	Kentucky
United States	GSK Investigational Site	Garden Grove	California
United States	GSK Investigational Site	Great Neck	New York
United States	GSK Investigational Site	Greensboro	North Carolina
United States	GSK Investigational Site	Greer	South Carolina
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Kettering	Ohio
United States	GSK Investigational Site	Lacey	Washington
United States	GSK Investigational Site	Lincoln	Nebraska
United States	GSK Investigational Site	Louisville	Kentucky
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Memphis	Tennessee
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Newark	Delaware
United States	GSK Investigational Site	Newtown	Pennsylvania
United States	GSK Investigational Site	North Little Rock	Arkansas
United States	GSK Investigational Site	Ogden	Utah
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Omaha	Nebraska
United States	GSK Investigational Site	Orange	California
United States	GSK Investigational Site	Phoenix	Arizona
United States	GSK Investigational Site	Pittsburgh	Pennsylvania
United States	GSK Investigational Site	Portland	Oregon
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	Riverside	Illinois
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	Rockford	Illinois
United States	GSK Investigational Site	Roseville	California
United States	GSK Investigational Site	Salisbury	Massachusetts
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Silver Spring	Maryland
United States	GSK Investigational Site	Slidell	Louisiana
United States	GSK Investigational Site	Spring Valley	California
United States	GSK Investigational Site	Springfield	Massachusetts
United States	GSK Investigational Site	St. Joseph	Michigan
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	St. Petersburg	Florida
United States	GSK Investigational Site	St. Petersburg	Florida
United States	GSK Investigational Site	Stamford	Connecticut
United States	GSK Investigational Site	Torrance	California
United States	GSK Investigational Site	Torrington	Connecticut
United States	GSK Investigational Site	Wheat Ridge	Colorado
United States	GSK Investigational Site	Wilmington	North Carolina
United States	GSK Investigational Site	Wilmington	North Carolina
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Netherlands,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	- 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.