Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness | Completed
Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
Health Conditions
  • Opioid-Induced Constipation
Completed
Recruitment Status
NCT00672477
Primary Trial ID Number
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.
Primary Outcome Measures
  • The proportion of subjects who have a rescue-free laxation response within 4 hours after at least 2 of the first 4 doses; 7 days
Secondary Outcome Measures
  • Time to first rescue-free laxation; 2 days; Proportion of subjects with rescue-free laxation within 4 hours after the first dose of study drug; 1 day; Proportion of subjects with rescue-free laxation within 4 or 24 hours after each dose; 14 days; Proportion of subjects with rescue-free laxation within 4 hours after at least 4 of the maximum 7 doses; 14 days; Number of laxations per week; 14 days; Number of rescue-free laxations per week; 14 days; Time to first rescue-free laxation within 4 hours; 1 day; Time to first rescue-free laxation within 24 hours; 1 day; Time to first rescue-free laxation after each dose; 14 days; Proportion of subjects using rescue laxatives during the double-blind period; 14 days; Proportion of subjects using enemas during the double-blind period; 14 days; Proportion of subjects having manual disimpaction procedures performed during the double-blind period; 14 days
Research Question
  • 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.
Design Type
Sorry, this information is not available
Ethics Approval
Sorry, this information is not available
Publications
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Countries of Recruitment
United States; Australia; Belgium; Brazil; Canada; France; Germany; Italy; Mexico; Spain; Sweden; United Kingdom
Participant Sex
Both
Participant Age Range
18 Years to N/A
Participant Type
Sorry, this information is not available
Trial Sample Size
254
Participant Inclusion Criteria
  • 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.
Participant Exclusion Criteria
  • 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.
Interventions
Drug; Methylnaltrexone bromide; Methylnatrexone (either 0.2ml, 0.4ml or 0.6ml) subcutaneously every other day for 14 days (ie, 7 doses); [Methylnaltrexone bromide]; Drug; Placebo; Placebo (either 0.2ml, 0.4ml or 0.6ml) subcutaneously every other day for 14 days (ie, 7 doses); [Placebo]
Design Details
Sorry, this information is not available
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Results Reporting
Sorry, this information is not available
Acronym
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Scientific Title
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
Secondary Trial Identifying Number
B2541005
Website
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3200K1-4000&StudyName=Study%20Evaluating%20Subcutaneous%20Methylnaltrexone%20For%20Treatment%20Of%20Opioid-Induced%20Constipation%20In%20Patients%20With%20Advanced%20Illness
Study Funded By
Salix Pharmaceuticals
Funder Type
Sorry, this information is not available
Study Sponsored By
Salix Pharmaceuticals
Study Also Sponsored By
Progenics Pharmaceuticals, Inc.
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment
Date Not Available
Recruitment End Date
Date Not Available
Trial End Date
Date Not Available
Date added to Registry

02 May 2008

Last Updated

07 Nov 2013

Date Record Refreshed on UKCTG

31 Jul 2015