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

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Opioid-Induced Constipation
Unfortunately contact details are not available for this trial.
Primary Contact Details
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.
Research Details
    Sorry, this information is not available
Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : Methylnaltrexone bromide, Drug : Placebo

Study Arm Groups : Methylnaltrexone bromide, Placebo

Intervention Type
See Interventions above
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
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - N/A
Who Can Participate
Patients
Number of Participants
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
This is in the inclusion criteria above
Trial Location(s)
Leckampton Hall Hospice
Cheltenham
Gloucestershire
GL53 0QJ
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Mexico, Spain, Sweden, United Kingdom
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
EudraCT Number
Not available for this trial
Funder(s)
  • Progenics Pharmaceuticals, Inc.
Other Study ID Numbers
3200K1-4000
Sponsor(s)
Salix Pharmaceuticals
Key Dates

Recruitment Start Date

Jun 2008

Recruitment End Date

Feb 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

02 May 2008

Last Updated

07 Nov 2013