Study 767905/008 Extension Study: Alvimopan for Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

September 1, 2015 updated by: Cubist Pharmaceuticals LLC

A Double-Blind, Placebo-Controlled, Multicenter Phase IIb Extension Study to Evaluate the Safety and Efficacy of Multiple Alvimopan Dosage Regimens for the Treatment of Opioid-Induced Bowel Dysfunction in Cancer Pain Subjects

Study SB-767905/008 was a multicenter study to evaluate the effectiveness and safety of multiple dosage regimens of an investigational drug for the treatment of constipation due to prescription pain medication in participants with cancer pain.

Study ABD101684 will serve as an extension to Study SB-767905/008 and offer continued access to blinded investigational product to participants who have completed the original study. The purpose of Study ABD101684 is to evaluate the safety and efficacy of alvimopan compared to placebo in subjects who completed Study SB-767905/008 and elected to participate in this extension study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • GSK Investigational Site
    • Newfoundland and Labrador
      • Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
        • GSK Investigational Site
    • Ontario
      • Kitchener, Ontario, Canada, N2G 1G3
        • GSK Investigational Site
      • Sudbury, Ontario, Canada, P3E 5J1
        • GSK Investigational Site
    • Quebec
      • Bonaventure, Quebec, Canada, G0C 1E0
        • GSK Investigational Site
      • Chandler, Quebec, Canada, G0C 1K0
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • GSK Investigational Site
  • Finland
      • Helsinki, Finland, 00029
        • GSK Investigational Site
  • France
      • Bordeaux Cedex, France, 33076
        • GSK Investigational Site
      • Strasbourg, France, 67000
        • GSK Investigational Site
      • Vandoeuvre-Les-Nancy, France, 54511
        • GSK Investigational Site
      • Villejuif Cedex, France, 94805
        • GSK Investigational Site
  • Hong Kong
      • Kwun Tong, Hong Kong
        • GSK Investigational Site
  • New Zealand
      • Wellington, New Zealand, 6002
        • GSK Investigational Site
  • Pakistan
      • Lahore, Pakistan, 54600
        • GSK Investigational Site
  • Peru
      • Lima, Peru, Lima 34
        • GSK Investigational Site
  • Poland
      • Bialystok, Poland, 15-540
        • GSK Investigational Site
      • Lublin, Poland, 20-090
        • GSK Investigational Site
      • Olsztyn, Poland, 10-228
        • GSK Investigational Site
      • Otwock, Poland, 05-400
        • GSK Investigational Site
      • Poznan, Poland, 60-569
        • GSK Investigational Site
  • Portugal
      • Lisboa, Portugal, 1070
        • GSK Investigational Site
      • Lisboa, Portugal, 1800
        • GSK Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 117216
        • GSK Investigational Site
  • Spain
      • Alcorcon, Spain, 28922
        • GSK Investigational Site
  • United Kingdom
      • Nottingham, United Kingdom, NG5 1PB
        • GSK Investigational Site
  • United States
    • California
      • Duarte, California, United States, 91010
        • GSK Investigational Site
      • Fountain Valley, California, United States, 92708
        • GSK Investigational Site
      • La Verne, California, United States, 91750
        • GSK Investigational Site
      • Sacramento, California, United States, 95819
        • GSK Investigational Site
      • San Diego, California, United States, 92103
        • GSK Investigational Site
    • Florida
      • New Port Richey, Florida, United States, 34652
        • GSK Investigational Site
      • Tampa, Florida, United States, 33612-9497
        • GSK Investigational Site
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • GSK Investigational Site
      • Worcester, Massachusetts, United States, 01608
        • GSK Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • GSK Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • GSK Investigational Site
      • Hendersonville, North Carolina, United States, 28793
        • GSK Investigational Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Completed GSK sponsored alvimopan (opioid-induced bowel dysfunction) OBD study for subjects with cancer-related pain, e.g. SB-767905/008.
  • Taking full agonist opioid therapy for cancer related pain.
  • Met entry criteria of OBD in original study and per investigator continues to require therapy for management of OBD.
  • Capable of completing paper questionnaires at the study visits.

Exclusion Criteria:

  • Unable to eat or drink.
  • Taking opioids for management of drug addiction.
  • Unable to use only rescue laxatives provided.
  • Inappropriately managed severe constipation that puts subject at risk of complications.
  • Has gastrointestinal (GI) or pelvic disorder known to affect bowel transit.
  • Concomitant medication(s), medical condition, or clinically significant laboratory abnormality that could jeopardize subject and also contraindicate study participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alvimopan 0.5 mg Twice Daily (BID)
0.5 milligrams (mg) of alvimopan was administered orally once in the morning and once in the evening.
Drug: alvimopan
Experimental: Alvimopan 1 mg Once Daily (QD)

Participants who did not have an interruption in blinded investigational product between the original study and the extension study received Alvimopan 1 mg in the morning and received placebo in the evening.

Participants who had an interruption in blinded investigational product between studies received 0.5 mg of alvimopan in the morning and placebo in the evening for 3 days, then 1 mg of alvimopan in the morning and placebo in the evening for the remaining 3 weeks.
Drug: placebo
Drug: alvimopan
Experimental: Alvimopan 1 mg Twice Daily (BID)

Participants who did not have an interruption in blinded investigational product between the original study and the extension study received Alvimopan 1 mg once in the morning and once in the evening.

Participants who had an interruption in blinded investigational product between studies received 0.5 mg of alvimopan once in the morning and once in the evening for 3 days, then 1 mg of alvimopan once in the morning and once in the evening.
Drug: alvimopan
Placebo Comparator: Placebo
Placebo was administered orally once in the morning and once in evening.
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of reported adverse events, including serious adverse events

Secondary Outcome Measures

Outcome Measure
Incidence of treatment-limiting toxicities, changes in pain intensity, patient satisfaction, health outcome measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cubist Pharmaceuticals LLC

Collaborators

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

August 24, 2005

First Submitted That Met QC Criteria

August 24, 2005

First Posted (Estimate)

August 26, 2005

Study Record Updates

Last Update Posted (Estimate)

September 2, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABD101684

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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