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Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness

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: NCT00672477
Recruitment Status : Completed
First Posted : May 6, 2008
Results First Posted : March 8, 2018
Last Update Posted : March 8, 2018
Sponsor:
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Tracking Information
First Submitted Date  ICMJE May 2, 2008
First Posted Date  ICMJE May 6, 2008
Results First Submitted Date  ICMJE February 7, 2018
Results First Posted Date  ICMJE March 8, 2018
Last Update Posted Date March 8, 2018
Study Start Date  ICMJE June 2008
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2018)
The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses [ Time Frame: 7 days ]
This outcome measures the proportion of subjects who had a rescue-free laxation (ie, bowel movement) within 4 hours after at least 2 of the first 4 doses of study drug. A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.
Original Primary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
The effect of the intervention will be measured by bowel movements. [ Time Frame: 14 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2018)
Time to First Rescue-free Laxation (Following the First Dose of Study Drug). [ Time Frame: 14 days ]
This outcome measures the time from first dose of study drug to the first rescue-free laxation (ie, bowel movement). A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
Bowel movements and health outcome measures [ Time Frame: 14 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Adults With Advanced Illness And Opioid-Induced Constipation: Efficacy, Safety, And Additional Health Outcomes
Brief Summary This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Opioid-Induced Constipation
Intervention  ICMJE
  • Drug: Methylnaltrexone
    Other Names:
    • MOA-728
    • Relistor
  • Drug: Placebo
    Other Name: Control
Study Arms  ICMJE
  • Experimental: Methylnaltrexone
    Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; or 0.4 mL (8 mg) every other day if weight between 38 and <62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information.
    Intervention: Drug: Methylnaltrexone
  • Placebo Comparator: Placebo
    Placebo subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL every other day if weight ≥ 62kg; or 0.4 mL every other day if weight between 38 and < 62 kg. Subjects with impaired kidney function received reduced volumes of placebo solution to match the volumes used in the experimental group.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2018)
237
Original Estimated Enrollment  ICMJE
 (submitted: May 5, 2008)
350
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Is an adult 18 years of age or older
  • Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease)
  • Has a life expectancy of at least 1 month.
  • Is receiving opioids on a regular schedule (not just as-needed or rescue doses) for the control of pain or discomfort for at least 2 weeks before the first dose of study drug.
  • Has constipation that is caused by opioid medications.

Exclusion Criteria:

  • Has a known or suspected allergy to methylnaltrexone or other similar compounds (e.g. naltrexone or naloxone).
  • Has a known or suspected mechanical gastrointestinal obstruction.
  • Has any potential nonopioid cause of bowel dysfunction that might be a major contributor to the constipation.
  • Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study.
  • Receiving opioid antagonist or partial antagonist products.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Canada,   France,   Germany,   Italy,   Mexico,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Denmark,   Finland,   Netherlands,   Norway,   Portugal
 
Administrative Information
NCT Number  ICMJE NCT00672477
Other Study ID Numbers  ICMJE 3200K1-4000
B2541005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bausch Health Americas, Inc.
Original Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Current Study Sponsor  ICMJE Bausch Health Americas, Inc.
Original Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Progenics Pharmaceuticals, Inc.
Investigators  ICMJE
Study Director: Enoch Bortey Bausch Health Americas, Inc.
PRS Account Bausch Health Americas, Inc.
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP