Long-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Status and phase: Completed; Phase 3

Conditions: Constipation; Bowel Dysfunction

Treatments: Drug: Alvimopan; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00241722

3753-013

SB-767905/014 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 805 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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805 participants in 2 patient groups, including a placebo group

Alvimopan 0.5 mg Twice Daily (BID)

Experimental group

Description:

0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months.

Treatment:

Drug: Alvimopan

Placebo

Placebo Comparator group

Description:

Placebo was administered orally BID for 12 months.

Treatment:

Drug: Placebo