NCT00858754
Withdrawn
Phase 4
A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain
ConditionsOpioid-Induced Constipation
Overview
- Phase
- Phase 4
- Intervention
- methylnaltrexone
- Conditions
- Opioid-Induced Constipation
- Sponsor
- Bausch Health Americas, Inc.
- Locations
- 1
- Primary Endpoint
- Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments.
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Group 1 Active Drug
Methylnaltrexone
Intervention: methylnaltrexone
Group 2 Non-Active Drug
Placebo
Intervention: placebo
Outcomes
Primary Outcomes
Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments.
Time Frame: 1 Day
Secondary Outcomes
- 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)
Study Sites (1)
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