Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain

This study has been completed.

Sponsor:

Collaborator:

GlaxoSmithKline

Information provided by (Responsible Party):

Cubist Pharmaceuticals LLC

ClinicalTrials.gov Identifier:

NCT00256932

First received: November 21, 2005

Last updated: September 1, 2015

Last verified: December 2011

History of Changes

Purpose

Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) to one 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.

Condition	Intervention	Phase
Bowel Dysfunction Constipation	Drug: alvimopan Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Constipation

Drug Information available for: Alvimopan

U.S. FDA Resources

Further study details as provided by Cubist Pharmaceuticals LLC:

Primary Outcome Measures:

to compare alvimopan with placebo for efficacy in the treatment of OBD

Secondary Outcome Measures:

Safety and tolerability, quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data)


Enrollment:	518
Study Start Date:	August 2005
Study Completion Date:	May 2006

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: Placebo
Experimental: Alvimopan 0.5 mg once daily	Drug: alvimopan 0.5 mg Other Name: Entereg
Experimental: alvimopan 0.5 mg twice daily	Drug: alvimopan 0.5 mg Other Name: Entereg

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Has 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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256932

Show 200 Study Locations

Sponsors and Collaborators

Cubist Pharmaceuticals LLC

GlaxoSmithKline

Investigators


Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

Publications:

Jansen JP, Lorch D, Langan J, Lasko B, Hermanns K, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, Mortensen ER. A randomized, placebo-controlled phase 3 trial (Study SB-767905/012) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain. J Pain. 2011 Feb;12(2):185-93. doi: 10.1016/j.jpain.2010.06.012.


Responsible Party:	Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier:	NCT00256932 History of Changes
Other Study ID Numbers:	SB-767905/012
Study First Received:	November 21, 2005
Last Updated:	September 1, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cubist Pharmaceuticals LLC:


bowel dysfunction constipation gastrointestinal opioids	pain non-cancer pain Opioid-induced

Additional relevant MeSH terms:


Constipation Intestinal Diseases Gastrointestinal Diseases Signs and Symptoms, Digestive Signs and Symptoms Digestive System Diseases Analgesics, Opioid Alvimopan	Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 23, 2016

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