WithdrawnPhase 4

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

Stopped: Withdrawn \[This study was terminated early by Wyeth, prior to dosing any subjects, for business reasons not related to safety.

United States, Canada0Started 2009-03

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments.

Timeframe: 1 Day

Trial details

NCT IDNCT00858754

SponsorBausch Health Americas, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-08

View on ClinicalTrials.gov More Opioid-Induced Constipation trials