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

This study has been completed.

First Received: October 17, 2005 Last Updated: March 6, 2009 History of Changes

Sponsors and Collaborators:	Adolor Corporation GlaxoSmithKline
Information provided by:	Adolor Corporation
ClinicalTrials.gov Identifier:	NCT00241722

Purpose

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.

Condition	Intervention	Phase
Bowel Dysfunction Constipation	Drug: alvimopan	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Constipation

Drug Information available for: LY246736 Alvimopan

U.S. FDA Resources

Further study details as provided by Adolor Corporation:

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:	750
Study Start Date:	August 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.
HIV-infected, has active hepatitis, or has ever been infected with hepatitis C.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241722

Show 227 Study Locations

Sponsors and Collaborators

Adolor Corporation

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SB-767905/014
Study First Received:	October 17, 2005
Last Updated:	March 6, 2009
ClinicalTrials.gov Identifier:	NCT00241722 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Adolor Corporation:

bowel dysfunction
constipation
gastrointestinal
opioids

pain
non-cancer pain
opioid-induced

Study placed in the following topic categories:

Signs and Symptoms
Signs and Symptoms, Digestive
Constipation
Central Nervous System Depressants

Pain
Peripheral Nervous System Agents
Analgesics
Analgesics, Opioid

Additional relevant MeSH terms:

Signs and Symptoms
Signs and Symptoms, Digestive
Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Constipation

Central Nervous System Depressants
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on September 10, 2009