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

April 10, 2015 updated by: GlaxoSmithKline

An Eight-week, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate Efficacy and Safety of Talnetant in Subjects With Irritable Bowel Syndrome

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

741

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • GSK Investigational Site
  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2606
        • GSK Investigational Site
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • GSK Investigational Site
      • Newtown, New South Wales, Australia, 2042
        • GSK Investigational Site
    • Queensland
      • Kippa Ring, Queensland, Australia, 4021
        • GSK Investigational Site
      • Spring Hill, Queensland, Australia, 4000
        • GSK Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • GSK Investigational Site
      • Bedford Park, South Australia, Australia, 5042
        • GSK Investigational Site
      • Port Lincoln, South Australia, Australia, 5606
        • GSK Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • GSK Investigational Site
      • Fitzroy, Victoria, Australia, 3065
        • GSK Investigational Site
      • Malvern, Victoria, Australia, 3144
        • GSK Investigational Site
      • Melbourne, Victoria, Australia, 3004
        • GSK Investigational Site
  • Canada
      • Quebec, Canada, G1S 4L8
        • GSK Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2X8
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • GSK Investigational Site
      • Truro, Nova Scotia, Canada, B2N 1L2
        • GSK Investigational Site
    • Ontario
      • Mississauga, Ontario, Canada, L5A 1N1
        • GSK Investigational Site
      • Sudbury, Ontario, Canada, P3E 6B4
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M9W 4L6
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M3J 1N2
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M3N 2V7
        • GSK Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H2X 3J4
        • GSK Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • GSK Investigational Site
      • Sainte Jerome, Quebec, Canada, J7Z 5T3
        • GSK Investigational Site
      • Sainte-Foy, Quebec, Canada, G1V 1V6
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • GSK Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 1J5
        • GSK Investigational Site
  • France
      • Caen, France, 14000
        • GSK Investigational Site
      • Clermont-Ferrand Cedex, France, 63058
        • GSK Investigational Site
      • Grenoble Cedex, France, 38043
        • GSK Investigational Site
      • Issoire, France, 63500
        • GSK Investigational Site
      • Marseille, France, 13002
        • GSK Investigational Site
      • Miramas, France, 13140
        • GSK Investigational Site
      • Nice, France, 06002
        • GSK Investigational Site
      • Vitry sur Seine, France, 94400
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10117
        • GSK Investigational Site
      • Berlin, Germany, 13125
        • GSK Investigational Site
      • Berlin, Germany, 10629
        • GSK Investigational Site
      • Hamburg, Germany, 20249
        • GSK Investigational Site
    • Sachsen
      • Chemnitz, Sachsen, Germany, 09120
        • GSK Investigational Site
      • Dresden, Sachsen, Germany, 01067
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04107
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04229
        • GSK Investigational Site
    • Schleswig-Holstein
      • Bad Segeberg, Schleswig-Holstein, Germany, 23795
        • GSK Investigational Site
  • Netherlands
      • Stadskanaal, Netherlands, 9501 HE
        • GSK Investigational Site
  • South Africa
      • Claremont, South Africa, 7708
        • GSK Investigational Site
      • N1 City, South Africa, 7460
        • GSK Investigational Site
      • Parktown, South Africa, 2193
        • GSK Investigational Site
      • Somerset West, South Africa, 7130
        • GSK Investigational Site
  • Spain
      • Badalona, Spain, 08916
        • GSK Investigational Site
      • Barcelona, Spain, 08025
        • GSK Investigational Site
      • Barcelona, Spain, 08022
        • GSK Investigational Site
      • Madrid, Spain, 28040
        • GSK Investigational Site
      • Oviedo, Spain, 33006
        • GSK Investigational Site
  • Sweden
      • Göteborg, Sweden, SE-413 45
        • GSK Investigational Site
      • Nacka, Sweden, SE-131 83
        • GSK Investigational Site
      • Stockholm, Sweden, SE-171 76
        • GSK Investigational Site
      • Stockholm, Sweden, SE-141 86
        • GSK Investigational Site
  • United Kingdom
      • Leeds, United Kingdom, LS12 1JE
        • GSK Investigational Site
      • Portergate, Sheffield, United Kingdom, S11
        • GSK Investigational Site
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY4 3AD
        • GSK Investigational Site
      • Blackpool, Lancashire, United Kingdom, FY2 9RS
        • GSK Investigational Site
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • GSK Investigational Site
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85016
        • GSK Investigational Site
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • GSK Investigational Site
    • California
      • Carmichael, California, United States, 95608
        • GSK Investigational Site
      • Concord, California, United States, 94520
        • GSK Investigational Site
      • Garden Grove, California, United States, 92840
        • GSK Investigational Site
      • Orange, California, United States, 92868
        • GSK Investigational Site
      • Roseville, California, United States, 95661
        • GSK Investigational Site
      • Spring Valley, California, United States, 91978
        • GSK Investigational Site
      • Torrance, California, United States, 90506
        • GSK Investigational Site
    • Colorado
      • Boulder, Colorado, United States, 80304
        • GSK Investigational Site
      • Centennial, Colorado, United States, 80112
        • GSK Investigational Site
      • Wheat Ridge, Colorado, United States, 80033
        • GSK Investigational Site
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • GSK Investigational Site
      • Stamford, Connecticut, United States, 06905
        • GSK Investigational Site
      • Torrington, Connecticut, United States, 06790
        • GSK Investigational Site
    • Delaware
      • Newark, Delaware, United States, 19713
        • GSK Investigational Site
    • Florida
      • Deland, Florida, United States, 32720
        • GSK Investigational Site
      • Miami, Florida, United States, 33173
        • GSK Investigational Site
      • St. Petersburg, Florida, United States, 33709
        • GSK Investigational Site
      • St. Petersburg, Florida, United States, 33707
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • GSK Investigational Site
    • Illinois
      • Riverside, Illinois, United States, 60546
        • GSK Investigational Site
      • Rockford, Illinois, United States, 61107
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • GSK Investigational Site
    • Kentucky
      • Florence, Kentucky, United States, 41042
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 40202
        • GSK Investigational Site
    • Louisiana
      • Slidell, Louisiana, United States, 70458
        • GSK Investigational Site
    • Maryland
      • Silver Spring, Maryland, United States, 20901
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • GSK Investigational Site
      • Salisbury, Massachusetts, United States, 01952
        • GSK Investigational Site
      • Springfield, Massachusetts, United States, 01107
        • GSK Investigational Site
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • GSK Investigational Site
      • St. Joseph, Michigan, United States, 49085
        • GSK Investigational Site
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • GSK Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • GSK Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68503
        • GSK Investigational Site
      • Omaha, Nebraska, United States, 68144
        • GSK Investigational Site
    • New Jersey
      • Blackwood, New Jersey, United States, 08012
        • GSK Investigational Site
    • New York
      • Bronx, New York, United States, 10461
        • GSK Investigational Site
      • East Syracuse, New York, United States, 13057
        • GSK Investigational Site
      • Fishkill, New York, United States, 12524
        • GSK Investigational Site
      • Great Neck, New York, United States, 11021
        • GSK Investigational Site
      • Rochester, New York, United States, 14609
        • GSK Investigational Site
      • Rochester, New York, United States, 14607
        • GSK Investigational Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27403
        • GSK Investigational Site
      • Raleigh, North Carolina, United States, 27612
        • GSK Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • GSK Investigational Site
      • Wilmington, North Carolina, United States, 28412
        • GSK Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Investigational Site
    • Ohio
      • Akron, Ohio, United States, 44310
        • GSK Investigational Site
      • Kettering, Ohio, United States, 45429
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • GSK Investigational Site
      • Medford, Oregon, United States, 97504
        • GSK Investigational Site
      • Portland, Oregon, United States, 97225
        • GSK Investigational Site
    • Pennsylvania
      • Newtown, Pennsylvania, United States, 18940
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15224
        • GSK Investigational Site
    • South Carolina
      • Greer, South Carolina, United States, 29651
        • GSK Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • GSK Investigational Site
      • Chattanooga, Tennessee, United States, 37404
        • GSK Investigational Site
      • Memphis, Tennessee, United States, 38119
        • GSK Investigational Site
      • Memphis, Tennessee, United States, 38120
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78745
        • GSK Investigational Site
      • El Paso, Texas, United States, 79905
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78209
        • GSK Investigational Site
    • Utah
      • Ogden, Utah, United States, 84405
        • GSK Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • GSK Investigational Site
      • Christiansburg, Virginia, United States, 24073
        • GSK Investigational Site
    • Washington
      • Lacey, Washington, United States, 98516
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
- 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

January 18, 2005

First Submitted That Met QC Criteria

January 18, 2005

First Posted (Estimate)

January 19, 2005

Study Record Updates

Last Update Posted (Estimate)

April 13, 2015

Last Update Submitted That Met QC Criteria

April 10, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 223412/068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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