A Randomized, Double-Blind, Placebo-Controlled Study of a Fixed Dose of Subcutaneous Methylnaltrexone in Adults With Advanced Illness and Opioid-Induced Constipation: Efficacy, Safety, and Additional Health Outcomes

Salix Pharmaceuticals Inc0 sites254 target enrollmentOctober 9, 2008

Overview

No summary available.

Registry

who.int

Start Date

October 9, 2008

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•The subject:
•1\.Is a man or woman aged 18 years or older.
•2\.Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer or other end\-stage disease).
•3\.Has a life expectancy of \= 1 month.
•4\.In the opinion of the investigator, has sufficient cognitive function to answer patient\-reported outcomes (PRO) questions.
•5\.Is receiving opioids, both
•a.On a regular schedule, not just as\-needed (PRN) or rescue doses, for the control of pain or discomfort for at least 2 weeks before the first dose of test article, and
•b.On a stable opioid regimen for at least 3 days before the first dose of test article. Stable” is defined as no reduction in dose of \=50%. Increases to the opioid regimen are permitted.
•6\.Has a diagnosis of constipation, defined as either
•a.Fewer than 3 bowel movements during the previous week by history, and no clinically notable laxation in the 24 hours before the first dose of test article, or

•The subject:
•1\.Has received treatment with methylnaltrexone at any time during the 7 days before the first dose of test article.
•2\.Has a known or suspected mechanical gastrointestinal obstruction; or a known/suspected lesion of the gastrointestinal tract that, in the opinion of the investigator, might be associated with an increased risk of gastrointestinal perforation.
•3\.Has any potential nonopioid cause of bowel dysfunction that in the opinion of the investigator might be a major contributor to the constipation.
•4\.Has clinically significant active diverticular disease as determined by the investigator.
•5\.Has evidence of current fecal impaction by physical examination or previously performed x\-ray examination.
•6\.Has physical evidence of peritonitis.
•7\.Has a history of bowel surgery within 10 days before test article administration.
•8\.Has a fecal ostomy.
•9\.Has used vinca alkaloids (eg, vincristine, vinblastine, or vinorelbine) at any time during the 4 months before screening.