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

NCT00101985 | Completed Phase 2

• 1 other identifier: 223412/068
• Study Type: interventional
• Target: 741
• Locations: 10 countries
• Sites: 134

Brief Summary

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

Conditions

Irritable Colon

Keywords

Quality of Life; Irritable bowel syndrome; IBS; SB223412; Qol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• - 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.

Interventions

talnetant DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (135)

GSK Investigational Site

Chandler, Arizona, 85224, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85016, United States

Location

GSK Investigational Site

North Little Rock, Arkansas, 72117, United States

Location

GSK Investigational Site

Carmichael, California, 95608, United States

Location

GSK Investigational Site

Concord, California, 94520, United States

Location

GSK Investigational Site

Garden Grove, California, 92840, United States

Location

GSK Investigational Site

Orange, California, 92868, United States

Location

GSK Investigational Site

Roseville, California, 95661, United States

Location

GSK Investigational Site

Spring Valley, California, 91978, United States

Location

GSK Investigational Site

Torrance, California, 90506, United States

Location

GSK Investigational Site

Boulder, Colorado, 80304, United States

Location

GSK Investigational Site

Centennial, Colorado, 80112, United States

Location

GSK Investigational Site

Wheat Ridge, Colorado, 80033, United States

Location

GSK Investigational Site

Bristol, Connecticut, 06010, United States

Location

GSK Investigational Site

Stamford, Connecticut, 06905, United States

Location

GSK Investigational Site

Torrington, Connecticut, 06790, United States

Location

GSK Investigational Site

Newark, Delaware, 19713, United States

Location

GSK Investigational Site

DeLand, Florida, 32720, United States

Location

GSK Investigational Site

Miami, Florida, 33173, United States

Location

GSK Investigational Site

St. Petersburg, Florida, 33707, United States

Location

GSK Investigational Site

St. Petersburg, Florida, 33709, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30328, United States

Location

GSK Investigational Site

Riverside, Illinois, 60546, United States

Location

GSK Investigational Site

Rockford, Illinois, 61107, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46237, United States

Location

GSK Investigational Site

Florence, Kentucky, 41042, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40202, United States

Location

GSK Investigational Site

Slidell, Louisiana, 70458, United States

Location

GSK Investigational Site

Silver Spring, Maryland, 20901, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02118, United States

Location

GSK Investigational Site

Salisbury, Massachusetts, 01952, United States

Location

GSK Investigational Site

Springfield, Massachusetts, 01107, United States

Location

GSK Investigational Site

Chesterfield, Michigan, 48047, United States

Location

GSK Investigational Site

Saint Joseph, Michigan, 49085, United States

Location

GSK Investigational Site

Chaska, Minnesota, 55318, United States

Location

GSK Investigational Site

St Louis, Missouri, 63141, United States

Location

GSK Investigational Site

Lincoln, Nebraska, 68503, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68144, United States

Location

GSK Investigational Site

Blackwood, New Jersey, 08012, United States

Location

GSK Investigational Site

East Syracuse, New York, 13057, United States

Location

GSK Investigational Site

Fishkill, New York, 12524, United States

Location

GSK Investigational Site

Great Neck, New York, 11021, United States

Location

GSK Investigational Site

Rochester, New York, 14607, United States

Location

GSK Investigational Site

Rochester, New York, 14609, United States

Location

GSK Investigational Site

The Bronx, New York, 10461, United States

Location

GSK Investigational Site

Greensboro, North Carolina, 27403, United States

Location

GSK Investigational Site

Raleigh, North Carolina, 27612, United States

Location

GSK Investigational Site

Wilmington, North Carolina, 28401, United States

Location

GSK Investigational Site

Wilmington, North Carolina, 28412, United States

Location

GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

GSK Investigational Site

Akron, Ohio, 44310, United States

Location

GSK Investigational Site

Kettering, Ohio, 45429, United States

Location

GSK Investigational Site

Oklahoma City, Oklahoma, 73112, United States

Location

GSK Investigational Site

Eugene, Oregon, 97401, United States

Location

GSK Investigational Site

Medford, Oregon, 97504, United States

Location

GSK Investigational Site

Portland, Oregon, 97225, United States

Location

GSK Investigational Site

Newtown, Pennsylvania, 18940, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15224, United States

Location

GSK Investigational Site

Greer, South Carolina, 29651, United States

Location

GSK Investigational Site

Bristol, Tennessee, 37620, United States

Location

GSK Investigational Site

Chattanooga, Tennessee, 37404, United States

Location

GSK Investigational Site

Memphis, Tennessee, 38119, United States

Location

GSK Investigational Site

Memphis, Tennessee, 38120, United States

Location

GSK Investigational Site

Austin, Texas, 78745, United States

Location

GSK Investigational Site

El Paso, Texas, 79905, United States

Location

GSK Investigational Site

San Antonio, Texas, 78209, United States

Location

GSK Investigational Site

Ogden, Utah, 84405, United States

Location

GSK Investigational Site

Charlottesville, Virginia, 22911, United States

Location

GSK Investigational Site

Christiansburg, Virginia, 24073, United States

Location

GSK Investigational Site

Lacey, Washington, 98516, United States

Location

GSK Investigational Site

Garran, Australian Capital Territory, 2606, Australia

Location

GSK Investigational Site

Concord, New South Wales, 2139, Australia

Location

GSK Investigational Site

Newtown, New South Wales, 2042, Australia

Location

GSK Investigational Site

Kippa-Ring, Queensland, 4021, Australia

Location

GSK Investigational Site

Spring Hill, Queensland, 4000, Australia

Location

GSK Investigational Site

Adelaide, South Australia, 5000, Australia

Location

GSK Investigational Site

Bedford Park, South Australia, 5042, Australia

Location

GSK Investigational Site

Port Lincoln, South Australia, 5606, Australia

Location

GSK Investigational Site

Box Hill, Victoria, 3128, Australia

Location

GSK Investigational Site

Fitzroy, Victoria, 3065, Australia

Location

GSK Investigational Site

Malvern, Victoria, 3144, Australia

Location

GSK Investigational Site

Melbourne, Victoria, 3004, Australia

Location

GSK Investigational Site

Edmonton, Alberta, T6G 2X8, Canada

Location

GSK Investigational Site

Halifax, Nova Scotia, B3H 1V7, Canada

Location

GSK Investigational Site

Truro, Nova Scotia, B2N 1L2, Canada

Location

GSK Investigational Site

Greater Sudbury, Ontario, P3E 6B4, Canada

Location

GSK Investigational Site

Mississauga, Ontario, L5A 1N1, Canada

Location

GSK Investigational Site

Toronto, Ontario, M3J 1N2, Canada

Location

GSK Investigational Site

Toronto, Ontario, M3N 2V7, Canada

Location

GSK Investigational Site

Toronto, Ontario, M9W 4L6, Canada

Location

GSK Investigational Site

Montreal, Quebec, H2X 3J4, Canada

Location

GSK Investigational Site

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

GSK Investigational Site

Québec, Quebec, G1S 4L8, Canada

Location

GSK Investigational Site

Sainte Jerome, Quebec, J7Z 5T3, Canada

Location

GSK Investigational Site

Sainte-Foy, Quebec, G1V 1V6, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 5N4, Canada

Location

GSK Investigational Site

Saskatoon, Saskatchewan, S7K 1J5, Canada

Location

GSK Investigational Site

Caen, 14000, France

Location

GSK Investigational Site

Clermont-Ferrand, 63058, France

Location

GSK Investigational Site

Grenoble, 38043, France

Location

GSK Investigational Site

Issoire, 63500, France

Location

GSK Investigational Site

Marseille, 13002, France

Location

GSK Investigational Site

Miramas, 13140, France

Location

GSK Investigational Site

Nice, 06002, France

Location

GSK Investigational Site

Vitry-sur-Seine, 94400, France

Location

GSK Investigational Site

Hamburg, Hamburg, 20249, Germany

Location

GSK Investigational Site

Chemnitz, Saxony, 09120, Germany

Location

GSK Investigational Site

Dresden, Saxony, 01067, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04107, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04229, Germany

Location

GSK Investigational Site

Bad Segeberg, Schleswig-Holstein, 23795, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10117, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 10629, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 13125, Germany

Location

GSK Investigational Site

Stadskanaal, 9501 HE, Netherlands

Location

GSK Investigational Site

Claremont, 7708, South Africa

Location

GSK Investigational Site

N1 City, 7460, South Africa

Location

GSK Investigational Site

Parktown, 2193, South Africa

Location

GSK Investigational Site

Somerset West, 7130, South Africa

Location

GSK Investigational Site

Badalona, 08916, Spain

Location

GSK Investigational Site

Barcelona, 08022, Spain

Location

GSK Investigational Site

Barcelona, 08025, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Oviedo, 33006, Spain

Location

GSK Investigational Site

Gothenburg, SE-413 45, Sweden

Location

GSK Investigational Site

Nacka, SE-131 83, Sweden

Location

GSK Investigational Site

Stockholm, SE-141 86, Sweden

Location

GSK Investigational Site

Stockholm, SE-171 76, Sweden

Location

GSK Investigational Site

Blackpool, Lancashire, FY2 9RS, United Kingdom

Location

GSK Investigational Site

Blackpool, Lancashire, FY4 3AD, United Kingdom

Location

GSK Investigational Site

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

GSK Investigational Site

Leeds, LS12 1JE, United Kingdom

Location

GSK Investigational Site

Portergate, Sheffield, S11, United Kingdom

Location

GSK Investigational Site

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

SB 223412

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2005
• First Posted: January 19, 2005
• Study Start: October 1, 2004
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: April 13, 2015

Record last verified: 2015-04

Locations

CA (16); DE (9); US (70); ES (5); FR (8); GB (5); AU (12); ZA (4); NL (1); SE (4)