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Safety of Subcutaneous Methylnaltrexone for 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: NCT00672139
Recruitment Status : Completed
First Posted : May 6, 2008
Results First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Collaborator:
Progenics Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief Summary:
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.

Condition or disease Intervention/treatment Phase
Opioid-Induced Constipation Drug: Methylnaltrexone bromide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label Extension Study To Assess The Safety Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Subjects With Advanced Illness And Opioid-Induced Constipation
Study Start Date : July 2008
Actual Primary Completion Date : January 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: Methylnaltrexone bromide

Methylnaltrexone subcutaneously as needed no more than 1 dose in a 24-hour period for a maximum of 10 weeks in this study.

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.

Drug: Methylnaltrexone bromide
Other Name: Relistor




Primary Outcome Measures :
  1. Number of Laxations Per Subject Within 24 Hours of Dosing Per Week. [ Time Frame: 10 weeks ]
    This was defined as the total number of days with a laxation (ie, a bowel movement) within 24 hours after dosing in each 7-day interval after the start of dosing. Results shown are the ranges (lowest and highest weekly values) of mean (± standard deviation) numbers of laxations within 24 hours of dosing per week during the 10-week treatment period for each group.



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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 completed study 3200K1-4000-WW, including 2 weeks of therapy and completion of all post baseline efficacy, safety, and health outcomes assessments.
  • Is receiving opioids on a regular schedule, not just as needed to control pain.
  • Likely to continue to need treatment of OIC for the duration of participation in the study.

Exclusion Criteria:

  • Has a suspected mechanical gastrointestinal obstruction, fecal impaction, or clinically important active diverticular disease as determined by the investigator.
  • Currently using an opioid antagonist or partial antagonist.
  • Has any other clinically important abnormalities such that risk to patient of participation outweighs the potential benefit of therapy as determined by the investigator

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): NCT00672139


Locations
Show Show 46 study locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Progenics Pharmaceuticals, Inc.
Investigators
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Study Director: Enoch Bortey Bausch Health Americas, Inc.
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT00672139    
Other Study ID Numbers: 3200K1-4001
B2541006
First Posted: May 6, 2008    Key Record Dates
Results First Posted: March 7, 2018
Last Update Posted: March 7, 2018
Last Verified: February 2018
Keywords provided by Bausch Health Americas, Inc.:
Opioid-Induced Constipation
Additional relevant MeSH terms:
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Constipation
Opioid-Induced Constipation
Signs and Symptoms, Digestive
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Bromides
Methylnaltrexone
Anticonvulsants
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents