Trial Information

Treatment of Opioid Induced Constipation (OIC) in Subjects with Chronic, Non Malignant Pain

A study designed to evaluate safety and effectiveness of a tablet form of methylnaltrexone to treat opioid induced constipation in patients with chronic non-malignant pain that require daily opioid therapy. 700 patients will be evaluated during the study which includes a 14 day screening period. All laxatives will be discontinued at screening & study permitted rescue can be used through screening & double blind periods. At randomization, qualified subjects will receive either 150 mg, 300 mg, 450 mg or placebo in the a.m.1.5 hrs. before food. The study will be for 84 days. The first 28 days will be once daily dosing and the remaining 56 days will be double blind prn dosing. There will be a follow up visit 14 days after the 12 wk double blind phase. All study related procedures, medications, and labs will be provided at no cost to the patient. You will be compensated for your time and travel.

Patient Inclusion Criteria:

Must be at least 18 years of age
Have a documented history of chronic non malignant pain of at least 2 months prior to screening
Taking oral, transdermal, intravenous, or subcutaneous opioids for at least 1 month
Have a history of constipation due to opioid use for at least 30 days prior to screening
Are currently taking laxative therapy for at least 30 days

Patient Exclusion Criteria:

Women who are pregnant, breastfeeding, or planning to become pregnant
Have a history of mechanical bowel obstruction or megacolon
Have fecal incontinence, rectal prolapse, or fecal ostomy
Have rectal bleeding with the past 60 days
Have any unstable liver, kidney, lung, cardiovascular (including hypertension), eye, neurologic, or psychiatric disorders

Rhonda Bovine, APN, MSN, CCRP, Clinical Director
ClinSearch, LLC
6035 Shallowford Road Suite 109
Chattanooga, TN 37421
Phone: 423-698-4584
Fax: 423-698-4577
Email: rbovine@clinsearch-us.com

View Map

Research Center Information: ClinSearch, LLC

If you would like to learn more about participating in this study, please send an email message using the form below.

Name:
Address:
City:
State:
Country:
Phone:
Email:
Message:

DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.