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Status:

COMPLETED

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

Lead Sponsor:

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

Collaborating Sponsors:

GlaxoSmithKline

Conditions:

Bowel Dysfunction

Constipation

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    August 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 1 2007

    Estimated Enrollment :

    805 Patients enrolled

    Trial Details

    Trial ID

    NCT00241722

    Start Date

    August 1 2005

    End Date

    February 1 2007

    Last Update

    August 30 2017

    Active Locations (227)

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    Page 1 of 57 (227 locations)

    1

    GSK Investigational Site

    Birmingham, Alabama, United States, 35215

    2

    GSK Investigational Site

    Birmingham, Alabama, United States, 35242

    3

    GSK Investigational Site

    Birmingham, Alabama, United States, 35244

    4

    GSK Investigational Site

    Huntsville, Alabama, United States, 35801