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

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Opioid-Induced Constipation

In brief

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.

Key facts

Study ID

NCT00858754

Run by

Bausch Health Americas, Inc.

People needed

0

Starts

2009-03-01

Expected to finish

2009-08-01

Last updated by the study team

2019-11-29

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Laguna Hills, California, United States
• Pfizer Investigational Site — Lancaster, California, United States
• Pfizer Investigational Site — Flat Rock, North Carolina, United States
• Pfizer Investigational Site — Madison, Wisconsin, United States
• Pfizer Investigational Site — Edmonton, Alberta, Canada
• Pfizer Investigational Site — Villejuif, France
• Pfizer Investigational Site — El Palmar, Murcia/Spain, Spain
• Pfizer Investigational Site —

Full record on ClinicalTrials.gov

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