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Sponsors and Collaborators: |
Adolor Corporation GlaxoSmithKline |
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Information provided by: | Adolor Corporation |
ClinicalTrials.gov Identifier: | NCT00256932 |
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 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 |
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Bowel Dysfunction Constipation |
Drug: alvimopan |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel 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:
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | SB-767905/012 |
Study First Received: | November 21, 2005 |
Last Updated: | March 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00256932 History of Changes |
Health Authority: | United States: Food and Drug Administration |
bowel dysfunction constipation gastrointestinal opioids |
pain non-cancer pain Opioid-induced |
Signs and Symptoms Signs and Symptoms, Digestive Constipation Central Nervous System Depressants |
Pain Peripheral Nervous System Agents Analgesics Analgesics, Opioid |
Signs and Symptoms Signs and Symptoms, Digestive Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Constipation |
Central Nervous System Depressants Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions Analgesics, Opioid |