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

Study Description

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Brief Summary:

Adults who are taking opioid therapy for persistent non-cancer pain and have resulting opioid-induced bowel dysfunction (OBD) will be randomized (1:1:1) 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 or disease	Intervention/treatment	Phase
Bowel Dysfunction; Constipation	Drug: alvimopan; Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	518 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	August 2005
Actual Study Completion Date :	May 2006

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 200 Study Locations

Sponsors and Collaborators

Cubist Pharmaceuticals LLC

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials, MD	GlaxoSmithKline

More Information

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Publications of Results:

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
First Posted:	November 22, 2005
Last Update Posted:	September 2, 2015
Last Verified:	December 2011

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