Status:
WITHDRAWN
Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects
Lead Sponsor:
Bausch Health Americas, Inc.
Collaborating Sponsors:
Progenics Pharmaceuticals, Inc.
Conditions:
Opioid-Induced Constipation
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00858754
Start Date
March 1 2009
End Date
August 1 2009
Last Update
November 29 2019
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Laguna Hills, California, United States, 92637
2
Pfizer Investigational Site
Lancaster, California, United States, 93534
3
Pfizer Investigational Site
Flat Rock, North Carolina, United States, 28731
4
Pfizer Investigational Site
Madison, Wisconsin, United States, 53792