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

Clinical Trial Details

Overview

Research Study Summary

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Active-controlled, Parallel-group, Multicenter Trial of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess the Analgesic Efficacy (Compared to Placebo) and the Management of Opioid-induced Constipation (Compared to Oxycodone Controlled-release Tablets (OXY)) in Opioid-experienced Subjects with Uncontrolled Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation who Require Around-the-clock Opioid Therapy.

Purpose

This study is for patients diagnosed with moderate to severe chronic low back pain and a history of opioid-induced constipation who require around the clock opioid therapy. This trial is being conducted in 104 sites across the U.S. There are 9 visits over the course of 19 weeks. Subjects will receive a patient stipend of $75 for each completed visit.

Patient Inclusion Criteria:

  • Male or female of age 18 years or above
  • Patients with chronic lower back pain (at least 3 hours daily) as predominant pain condition
  • History of opioid-induced constipation

Patient Exclusion Criteria:

  • History of any contraindication of pain
  • Diagnosed with IBS
  • History of any condition that would contraindicate opioid-constipation

To Learn more
Phase

3

Gender

Both Male and Female

Age

N/A

Overall Status

Recruiting

Duration

19 Weeks

Facility Type

N/A

Compensation

$75 to $675

Contact

Cheryl Nickles, Patient Recruitment Coordinator
Chase Medical Research, LLC
500 Chase Parkway, 3rd Floor
Waterbury, CT 06708
Phone: (203) 419-4404
Fax: (203) 465-7924

View Map

Research Center Information: Chase Medical Research, 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: 180767

Date Last Changed: July 19, 2013


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