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Sponsored by: |
GlaxoSmithKline |
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00259922 |
Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one of 2 alvimopan arms, or to placebo. The primary objective of this phase 3 confirmatory study is to compare alvimopan with placebo for efficacy in the treatment of OBD. The primary efficacy endpoint is based on frequency of bowel movements. Subjects will be required to: (1) track their bowel movements and other bowel symptoms and (2) attend 6 clinic visits over 4 months.
Condition | Intervention | Phase |
Bowel Dysfunction Constipation |
Drug: alvimopan |
Phase III |
MedlinePlus related topics: | Constipation |
ChemIDplus related topics: | Alvimopan LY246736 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Efficacy and Safety of Alvimopan 0.5mg Once Daily and 0.5mg Twice Daily for 12 Weeks for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Show 188 Study Locations |
GlaxoSmithKline |
Study Director: | GSK Clinical Trial, MD | GlaxoSmithKline |
Study ID Numbers: | SB-767905/013 |
First Received: | November 29, 2005 |
Last Updated: | September 13, 2006 |
ClinicalTrials.gov Identifier: | NCT00259922 |
Health Authority: | United States: Food and Drug Administration |
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