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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00241722

Enrollment

805

Registered

2005-10-19

Start date

2005-08-01

Completion date

2007-02-01

Last updated

2017-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Dysfunction, Constipation

Keywords

bowel dysfunction, constipation, gastrointestinal, opioids, pain, non-cancer pain, opioid-induced

Brief summary

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.

Interventions

DRUGAlvimopan

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
To compare alvimopan with placebo for long-term safety and tolerability	12 months

Secondary

Measure	Time frame
Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)	12 months

Countries

Australia, Austria, Canada, Denmark, Finland, Hong Kong, Hungary, Ireland, Netherlands, New Zealand, Poland, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026