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

NCT ID: NCT00101985

Last Updated: 2015-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

741 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Irritable Colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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talnetant

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Chandler, Arizona, United States

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Phoenix, Arizona, United States

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North Little Rock, Arkansas, United States

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Carmichael, California, United States

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Concord, California, United States

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Garden Grove, California, United States

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Orange, California, United States

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Roseville, California, United States

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Spring Valley, California, United States

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Torrance, California, United States

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Boulder, Colorado, United States

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Centennial, Colorado, United States

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Wheat Ridge, Colorado, United States

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Bristol, Connecticut, United States

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Stamford, Connecticut, United States

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Torrington, Connecticut, United States

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Newark, Delaware, United States

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DeLand, Florida, United States

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Miami, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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Atlanta, Georgia, United States

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Riverside, Illinois, United States

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Rockford, Illinois, United States

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Indianapolis, Indiana, United States

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Florence, Kentucky, United States

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Louisville, Kentucky, United States

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Slidell, Louisiana, United States

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Silver Spring, Maryland, United States

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Boston, Massachusetts, United States

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Salisbury, Massachusetts, United States

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Springfield, Massachusetts, United States

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Chesterfield, Michigan, United States

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Saint Joseph, Michigan, United States

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Chaska, Minnesota, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Blackwood, New Jersey, United States

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East Syracuse, New York, United States

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Fishkill, New York, United States

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Great Neck, New York, United States

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Rochester, New York, United States

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Rochester, New York, United States

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The Bronx, New York, United States

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Greensboro, North Carolina, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Akron, Ohio, United States

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Kettering, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Newtown, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Greer, South Carolina, United States

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Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Memphis, Tennessee, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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El Paso, Texas, United States

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San Antonio, Texas, United States

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Ogden, Utah, United States

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Charlottesville, Virginia, United States

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Christiansburg, Virginia, United States

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Lacey, Washington, United States

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Garran, Australian Capital Territory, Australia

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Concord, New South Wales, Australia

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Newtown, New South Wales, Australia

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Kippa-Ring, Queensland, Australia

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Spring Hill, Queensland, Australia

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Adelaide, South Australia, Australia

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Bedford Park, South Australia, Australia

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Port Lincoln, South Australia, Australia

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Box Hill, Victoria, Australia

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Fitzroy, Victoria, Australia

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Malvern, Victoria, Australia

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Melbourne, Victoria, Australia

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Edmonton, Alberta, Canada

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Halifax, Nova Scotia, Canada

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Truro, Nova Scotia, Canada

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Greater Sudbury, Ontario, Canada

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Mississauga, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Québec, Quebec, Canada

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Sainte Jerome, Quebec, Canada

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Sainte-Foy, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Caen, , France

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Clermont-Ferrand, , France

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Grenoble, , France

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Issoire, , France

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Marseille, , France

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Miramas, , France

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Nice, , France

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Vitry-sur-Seine, , France

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Hamburg, City state of Hamburg, Germany

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Chemnitz, Saxony, Germany

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Dresden, Saxony, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Bad Segeberg, Schleswig-Holstein, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Stadskanaal, , Netherlands

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Claremont, , South Africa

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N1 City, , South Africa

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Parktown, , South Africa

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Somerset West, , South Africa

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Badalona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Oviedo, , Spain

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Gothenburg, , Sweden

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Nacka, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Blackpool, Lancashire, United Kingdom

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Blackpool, Lancashire, United Kingdom

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Northwood, Middlesex, United Kingdom

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Leeds, , United Kingdom

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Portergate, Sheffield, , United Kingdom

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, ,

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Countries

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

Other Identifiers

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223412/068

Identifier Type: -

Identifier Source: org_study_id

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