Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
This study has been completed.
Information provided by:
First received: October 17, 2005
Last updated: March 6, 2009
Last verified: March 2009
Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1) to alvimopan or placebo. The primary objective of this phase 3 long-term safety study is to compare alvimopan with placebo for safety and tolerability in the treatment of OBD. The primary safety endpoint is based on the frequency of reported adverse events. Subjects will be required to attend 8 clinic visits over approximately 1 year.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate Long-Term Safety and Efficacy of Alvimopan 0.5mg Twice Daily for 12 Months for the Treatment of Opioid-Induced Bowel Dysfunction in Adults Taking Opioid Therapy for Persistent Non-Cancer Pain
Primary Outcome Measures:
- To compare alvimopan with placebo for long-term safety and tolerability [ Time Frame: 12 months ]
Secondary Outcome Measures:
- Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data) [ Time Frame: 12 months ]
| Estimated Enrollment:
| Study Start Date:
Other Name: alvimopan
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Consented to participate in this study.
- Taking opioid therapy for persistent non-cancer pain.
- Has bowel dysfunction mainly due to opioids.
- Has bowel dysfunction since starting opioids as defined by infrequent bowel movements and additional bowel-related symptoms.
- Willing to discontinue laxative therapy (will be provided study-specific standardized laxative if needed).
- Pregnant, lactating, or planning to become pregnant.
- Not ambulatory.
- Participated in another trial with an investigational drug in the past 30 days.
- Taking opioids for the management of drug addiction or cancer-related pain.
- Severe constipation whereby the subject is at immediate risk of developing serious complications of constipation.
- Gastrointestinal or pelvic disorders known to affect bowel transit, produce gastrointestinal (GI) obstruction, or contribute to bowel dysfunction.
- HIV-infected, has active hepatitis, or has ever been infected with hepatitis C.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00241722
||GSK Clinical Trials, MD
No publications provided
||Study Director, GSK
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 17, 2005
||March 6, 2009
||United States: Food and Drug Administration
Keywords provided by Cubist Pharmaceuticals:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 15, 2014
Signs and Symptoms, Digestive
Signs and Symptoms
Digestive System Diseases
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Central Nervous System Depressants