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

Study Description

Brief Summary

Detailed Description

Condition or disease	Intervention/treatment	Phase
Bowel Dysfunction Constipation	Drug: alvimopan Other Names Entereg Drug: Placebo Other Names	Phase 3

Tracking Information

First Submitted Date	November 21, 2005
Last Update Posted Date	September 01, 2015
Start Date	August 01, 2005
Actual Completion Date	May 01, 2006
Primary Completion Date	N/A
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current Primary Outcome Measures

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

Original Primary Outcome Measures

Current Secondary Outcome Measures

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

Original Secondary Outcome Measures

Study Design

Brief Title	Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
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
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.
Detailed Description
Study Type	Interventional
Study Phase	Phase 3
Estimated Enrollment	518
Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Quadruple
Primary Purpose	Treatment
Conditions	Bowel Dysfunction Constipation
Target Follow-Up Duration	N/A
Biospecimen:	N/A
Sampling Method	N/A
Study Population	N/A
Intervention	Drug: alvimopan 0.5 mg Other Names Entereg Drug: Placebo Other Names
Study Groups/Cohorts	Placebo Alvimopan 0.5 mg once daily alvimopan 0.5 mg twice daily
Study Arms	Experimental Alvimopan 0.5 mg once daily Drug : alvimopan 0.5 mg Experimental alvimopan 0.5 mg twice daily Drug : alvimopan 0.5 mg Placebo Comparator Placebo Drug : Placebo

Arm	Intervention/Treatment
Experimental Alvimopan 0.5 mg once daily	Drug : alvimopan 0.5 mg
Experimental alvimopan 0.5 mg twice daily	Drug : alvimopan 0.5 mg
Placebo Comparator Placebo	Drug : Placebo

Recruitment Information

Recruitment Status:	Completed
Enrollment	518
Completion Date	May 01, 2006
Eligibility 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.
Gender	All
Age	18 Years to N/A
Accepts Healthy Volunteers	No
Contacts	Not Available
Listed Location Countries	Austria Canada Denmark Estonia Finland Germany Ireland Poland United Kingdom United States

Administrative Information

NCT Number:	NCT00256932
Other Study ID Numbers	SB-767905/012
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Not Available
Responsible Party	,
Study Sponsor	Cubist Pharmaceuticals LLC
Collaborators	GlaxoSmithKline
Investigators	Study Director GSK Clinical Trials, MD GlaxoSmithKline