Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects

• Status: Withdrawn
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Collaborator: Progenics Pharmaceuticals, Inc.
• Treatments: Analgesics, Opioid; Methylnaltrexone; Naltrexone

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.