Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects
Phase 4
Withdrawn
- Conditions
- Opioid-Induced Constipation
- Interventions
- Drug: placebo
- Registration Number
- NCT00858754
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Is a man or woman aged 18 years or older.
- Has a body weight >= 38 kg.
- Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer).
- Has a life expectancy of >= 6 months.
- Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology Group (ECOG) scale.
- Is taking opioids for cancer-related pain, and not just as-needed doses.
- Has a diagnosis of OIC as determined by the investigator.
- Is willing to follow the protocol instructions on laxative use during the study.
Exclusion Criteria
- Has a history of chronic constipation before starting opioids.
- Has renal disease receiving dialysis.
- Has an ostomy for stools.
- Is a pregnant or breastfeeding woman.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2 Non-Active Drug placebo Placebo Group 1 Active Drug methylnaltrexone Methylnaltrexone
- Primary Outcome Measures
Name Time Method Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments. 1 Day
- Secondary Outcome Measures
Name Time Method 1. Bowel movements within 4 hours after at least 2 of the first 4 doses. 2. Bowel movements within 4 hours after all doses. 3. The time to bowel movement after the first dose. 2 weeks
Trial Locations
- Locations (1)
Pfizer Investigational Site