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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00101985
First received: January 18, 2005
Last updated: October 10, 2013
Last verified: April 2013
  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 Colon
Drug: talnetant
Phase 2

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

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
Intervention Details:
    Drug: talnetant
    Other Name: talnetant
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Arizona
GSK Investigational Site
Chandler, Arizona, United States, 85224
GSK Investigational Site
Phoenix, Arizona, United States, 85016
United States, Arkansas
GSK Investigational Site
North Little Rock, Arkansas, United States, 72117
United States, California
GSK Investigational Site
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
United States, Colorado
GSK Investigational Site
Boulder, Colorado, United States, 80304
GSK Investigational Site
Centennial, Colorado, United States, 80112
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
GSK Investigational Site
Bristol, Connecticut, United States, 06010
GSK Investigational Site
Stamford, Connecticut, United States, 06905
GSK Investigational Site
Torrington, Connecticut, United States, 06790
United States, Delaware
GSK Investigational Site
Newark, Delaware, United States, 19713
United States, Florida
GSK Investigational Site
Deland, Florida, United States, 32720
GSK Investigational Site
Miami, Florida, United States, 33173
GSK Investigational Site
St. Petersburg, Florida, United States, 33707
GSK Investigational Site
St. Petersburg, Florida, United States, 33709
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30328
United States, Illinois
GSK Investigational Site
Riverside, Illinois, United States, 60546
GSK Investigational Site
Rockford, Illinois, United States, 61107
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46237
United States, Kentucky
GSK Investigational Site
Florence, Kentucky, United States, 41042
GSK Investigational Site
Louisville, Kentucky, United States, 40202
United States, Louisiana
GSK Investigational Site
Slidell, Louisiana, United States, 70458
United States, Maryland
GSK Investigational Site
Silver Spring, Maryland, United States, 20901
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02118
GSK Investigational Site
Salisbury, Massachusetts, United States, 01952
GSK Investigational Site
Springfield, Massachusetts, United States, 01107
United States, Michigan
GSK Investigational Site
Chesterfield, Michigan, United States, 48047
GSK Investigational Site
St. Joseph, Michigan, United States, 49085
United States, Minnesota
GSK Investigational Site
Chaska, Minnesota, United States, 55318
United States, Missouri
GSK Investigational Site
St. Louis, Missouri, United States, 63141
United States, Nebraska
GSK Investigational Site
Lincoln, Nebraska, United States, 68503
GSK Investigational Site
Omaha, Nebraska, United States, 68144
United States, New Jersey
GSK Investigational Site
Blackwood, New Jersey, United States, 08012
United States, New York
GSK Investigational Site
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
United States, North Carolina
GSK Investigational Site
Greensboro, North Carolina, United States, 27403
GSK Investigational Site
Raleigh, North Carolina, United States, 27612
GSK Investigational Site
Wilmington, North Carolina, United States, 28412
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
GSK Investigational Site
Akron, Ohio, United States, 44310
GSK Investigational Site
Kettering, Ohio, United States, 45429
United States, Oklahoma
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
GSK Investigational Site
Medford, Oregon, United States, 97504
GSK Investigational Site
Portland, Oregon, United States, 97225
United States, Pennsylvania
GSK Investigational Site
Newtown, Pennsylvania, United States, 18940
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15224
United States, South Carolina
GSK Investigational Site
Greer, South Carolina, United States, 29651
United States, Tennessee
GSK Investigational Site
Bristol, Tennessee, United States, 37620
GSK Investigational Site
Chattanooga, Tennessee, United States, 37404
GSK Investigational Site
Memphis, Tennessee, United States, 38120
GSK Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78745
GSK Investigational Site
El Paso, Texas, United States, 79905
GSK Investigational Site
San Antonio, Texas, United States, 78209
United States, Utah
GSK Investigational Site
Ogden, Utah, United States, 84405
United States, Virginia
GSK Investigational Site
Charlottesville, Virginia, United States, 22911
GSK Investigational Site
Christiansburg, Virginia, United States, 24073
United States, Washington
GSK Investigational Site
Lacey, Washington, United States, 98516
Australia, Australian Capital Territory
GSK Investigational Site
Garran, Australian Capital Territory, Australia, 2606
Australia, New South Wales
GSK Investigational Site
Concord, New South Wales, Australia, 2139
GSK Investigational Site
Newtown, New South Wales, Australia, 2042
Australia, Queensland
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
GSK Investigational Site
Spring Hill, Queensland, Australia, 4000
Australia, South Australia
GSK Investigational Site
Adelaide, South Australia, Australia, 5000
GSK Investigational Site
Bedford Park, South Australia, Australia, 5042
GSK Investigational Site
Port Lincoln, South Australia, Australia, 5606
Australia, Victoria
GSK Investigational Site
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
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T6G 2X8
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3H 1V7
GSK Investigational Site
Truro, Nova Scotia, Canada, B2N 1L2
Canada, Ontario
GSK Investigational Site
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
Canada, Quebec
GSK Investigational Site
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
Canada, Saskatchewan
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 1J5
Canada
GSK Investigational Site
Quebec, Canada, G1S 4L8
France
GSK Investigational Site
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
Germany
GSK Investigational Site
Chemnitz, Sachsen, Germany, 09120
GSK Investigational Site
Dresden, Sachsen, Germany, 01067
GSK Investigational Site
Leipzig, Sachsen, Germany, 04229
GSK Investigational Site
Leipzig, Sachsen, Germany, 04107
GSK Investigational Site
Bad Segeberg, Schleswig-Holstein, Germany, 23795
GSK Investigational Site
Berlin, Germany, 10117
GSK Investigational Site
Berlin, Germany, 10629
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Hamburg, Germany, 20249
Netherlands
GSK Investigational Site
Stadskanaal, Netherlands, 9501 HE
South Africa
GSK Investigational Site
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
Spain
GSK Investigational Site
Badalona, Spain, 08916
GSK Investigational Site
Barcelona, Spain, 08022
GSK Investigational Site
Barcelona, Spain, 08025
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Oviedo, Spain, 33006
GSK Investigational Site
Unknown, Spain
Sweden
GSK Investigational Site
Göteborg, Sweden, SE-413 45
GSK Investigational Site
Nacka, Sweden, SE-131 83
GSK Investigational Site
Stockholm, Sweden, SE-141 86
GSK Investigational Site
Stockholm, Sweden, SE-171 76
United Kingdom
GSK Investigational Site
Blackpool, Lancashire, United Kingdom, FY2 9RS
GSK Investigational Site
Blackpool, Lancashire, United Kingdom, FY4 3AD
GSK Investigational Site
Northwood, Middlesex, United Kingdom, HA6 2RN
GSK Investigational Site
Leeds, United Kingdom, LS12 1JE
GSK Investigational Site
Portergate, Sheffield, United Kingdom, S11
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00101985     History of Changes
Other Study ID Numbers: 223412/068
Study First Received: January 18, 2005
Last Updated: October 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Quality of Life
Irritable bowel syndrome
IBS
SB223412
Qol

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 21, 2014