Alvimopan For The 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: | 4/21/2016 |
| Start Date: | August 2005 |
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
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.
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.
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).
- Willing to report daily bowel symptoms.
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.
- HIV-infected, has active hepatitis, or has ever been infected with hepatitis C.
We found this trial at
108
sites
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