Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
| Status: | Completed |
|---|---|
| Conditions: | Constipation, Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/31/2017 |
| Start Date: | August 1, 2005 |
| End Date: | February 1, 2007 |
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
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. Participants will be required to attend
8 clinic visits over approximately 1 year.
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. Participants will be required to attend
8 clinic visits over approximately 1 year.
Inclusion criteria:
- 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).
Exclusion criteria:
- 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.
- Human Immunodeficiency Virus (HIV)-infected, has active hepatitis, or has ever been
infected with hepatitis C.
We found this trial at
124
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