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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00256932
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : September 2, 2015
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Alvimopan

Arms and Interventions
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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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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256932


Locations
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Sponsors and Collaborators
Cubist Pharmaceuticals LLC
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline
More Information
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Publications of Results:

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Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT00256932    
Other Study ID Numbers: SB-767905/012
First Posted: November 22, 2005    Key Record Dates
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:
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Intestinal Diseases
Gastrointestinal Diseases
Constipation
Signs and Symptoms, Digestive
 Digestive System Diseases
Alvimopan
Gastrointestinal Agents