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

Phase 4

Withdrawn

• Conditions: Opioid-Induced Constipation
• Interventions: Drug: placebo; Drug: methylnaltrexone

• 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

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-09
• Study First Submitted QC: 2009-03-09
• Study First Posted: 2009-03-10
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-29

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• Status: WITHDRAWN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; Location not specified

Pfizer Investigational Site