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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00101985 |
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 Bowel Syndrome (IBS) |
Drug: talnetant |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 670 |
Study Start Date: | October 2004 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
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:
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.
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 223412/068 |
Study First Received: | January 18, 2005 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00101985 |
Health Authority: | United States: Food and Drug Administration |
IBS SB223412 Qol Quality of Life Irritable bowel syndrome |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Irritable Bowel Syndrome |
Quality of Life Intestinal Diseases Colonic Diseases, Functional |
Pathologic Processes Disease Syndrome |