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

ID: NCT00241722
Status: Completed
Phase: Phase 3
Start Date: August 01, 2005
First Submitted: October 17, 2005
Last Updated: August 29, 2017
Results: N/A
Sponsors & Collaborators: Cubist Pharmaceuticals LLC, GlaxoSmithKline
Location: Australia, Austria, Canada, Denmark, Finland, Hong Kong, Hungary, Ireland, Netherlands, New Zealand, Poland, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Conditions: Bowel Dysfunction, Constipation
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Bowel Dysfunction

Constipation

Drug: Alvimopan
Other Names
Drug: Placebo
Other Names
Phase 3

Tracking Information

First Submitted DateOctober 17, 2005
Last Update Posted DateAugust 29, 2017
Actual Start DateAugust 01, 2005
Actual Completion DateFebruary 01, 2007
Actual Primary Completion DateFebruary 01, 2007
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • To compare alvimopan with placebo for long-term safety and tolerability [Time Frame: 12 months]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Quality of life, pharmacokinetics, pharmacogenetics (dependent on results from other data) [Time Frame: 12 months]

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleLong-Term Safety Evaluation Of Treatment Of Constipation Due To Opioids Being Taken For Persistent Non-Cancer Pain
Official TitleA 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
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.

Detailed Description

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
805
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 MethodN/A
Study PopulationN/A
Intervention
Drug: Alvimopan

Other Names
Drug: Placebo

Other Names
Study Groups/Cohorts
Alvimopan 0.5 mg Twice Daily (BID)
0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months.

Placebo
Placebo was administered orally BID for 12 months.

Study Arms
Experimental Alvimopan 0.5 mg Twice Daily (BID)
0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months.
Drug : Alvimopan

Placebo Comparator Placebo
Placebo was administered orally BID for 12 months.
Drug : Placebo

Arm Intervention/Treatment
Experimental Alvimopan 0.5 mg Twice Daily (BID)
0.5 milligrams (mg) of alvimopan was administered orally twice daily (BID) for 12 months.
Drug : Alvimopan
Placebo Comparator Placebo
Placebo was administered orally BID for 12 months.
Drug : Placebo

Recruitment Information

Recruitment Status:Completed
Enrollment805
Completion DateFebruary 01, 2007
Eligibility 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.
- Human Immunodeficiency Virus (HIV)-infected, has active hepatitis, or has ever been infected with hepatitis C.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
Australia
Austria
Canada
Denmark
Finland
Hong Kong
Hungary
Ireland
Netherlands
New Zealand
Poland
Spain
Sweden
Switzerland
Taiwan
United Kingdom
United States
France

Administrative Information

NCT Number:NCT00241722
Other Study ID Numbers
3753-013
SB-767905/014
Has Data Monitoring CommitteeNo
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