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Therapeutic Areas: Neurology | Musculoskeletal | Family Medicine
Disease Category: Chronic Pain
Location: United States, TN

Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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

To Learn more
Phase

3

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Duration

84 Days

Facility Type

N/A

Contact

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

View Map

Research Center Information: ClinSearch, LLC

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 170278

Date Last Changed: July 23, 2013


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