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

NCT ID: NCT00259922

Last Updated: 2015-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

485 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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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 of 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.

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Detailed Description

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Conditions

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Bowel Dysfunction Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Alvimopan 0.5 mg once daily

0.5 mg once daily (QD)

Group Type EXPERIMENTAL

Alvimopan

Intervention Type DRUG

0.5 mg QD

Alvimopan 0.5 mg twice daily

0.5 mg twice daily (BID)

Group Type EXPERIMENTAL

Alviompan

Intervention Type DRUG

0.5 mg BID

Interventions

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Placebo

Placebo

Intervention Type DRUG

Alvimopan

0.5 mg QD

Intervention Type DRUG

Alviompan

0.5 mg BID

Intervention Type DRUG

Other Intervention Names

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Entereg Entereg

Eligibility Criteria

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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).
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Northport, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Scottsdale, Arizona, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Bakersfield, California, United States

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Beverly Hills, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Los Gatos, California, United States

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Northridge, California, United States

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Orange, California, United States

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Palm Springs, California, United States

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Pasadena, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Rafael, California, United States

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Santa Ana, California, United States

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Stamford, Connecticut, United States

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Waterbury, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Chiefland, Florida, United States

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Clearwater, Florida, United States

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Deerfield Beach, Florida, United States

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Destin, Florida, United States

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Fort Myers, Florida, United States

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Hollywood, Florida, United States

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Ocala, Florida, United States

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Saint Cloud, Florida, United States

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Fremantle, Western Australia, Australia

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Coquitlam, British Columbia, Canada

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Moncton, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Saint Romuald, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Boulogne, , France

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Grenoble, , France

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Montpellier, , France

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Athlone, Cape Town, , South Africa

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Erasmuskloof, Pretoria, , South Africa

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Fourways, Johannesburg, , South Africa

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Kempton Park, , South Africa

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Kenilworth, Cape Town, , South Africa

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Lynnwood, Pretoria, , South Africa

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Tygervalley, , South Africa

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Westridge, Mitchells Plain, , South Africa

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Alcorcón, , Spain

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Barcelona, , Spain

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Ferrol, , Spain

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Granada, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Santander, , Spain

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Valencia, , Spain

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Jönköping, , Sweden

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Karlstad, , Sweden

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Linköping, , Sweden

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Stockholm, , Sweden

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Bern, , Switzerland

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Nottwil, , Switzerland

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Countries

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United States Australia Canada France Hungary Netherlands New Zealand Norway South Africa Spain Sweden Switzerland

References

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Irving G, Penzes J, Ramjattan B, Cousins M, Rauck R, Spierings EL, Kleoudis CS, Snidow JW, Pierce A, Wurzelmann J, Mortensen ER. A randomized, placebo-controlled phase 3 trial (Study SB-767905/013) of alvimopan for opioid-induced bowel dysfunction in patients with non-cancer pain. J Pain. 2011 Feb;12(2):175-84. doi: 10.1016/j.jpain.2010.06.013.

Reference Type RESULT
PMID: 21292168 (View on PubMed)

Other Identifiers

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SB-767905/013

Identifier Type: -

Identifier Source: org_study_id

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