A Study of Oxycodone/Naloxone Controlled-release Tablets (OXN) to Assess Analgesic Efficacy and Management of Opioid-induced Constipation (OIC) in Opioid-experienced Subjects With Moderate to Severe Chronic Low Back Pain



Status:Completed
Conditions:Back Pain, Constipation
Therapuetic Areas:Gastroenterology, Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:August 2011
End Date:May 2015
Contact:Patient Recruitment Specialist
Email:convergestudy@quintiles.com
Phone:1-855-253-3456

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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 Moderate to Severe Chronic Low Back Pain and a History of Opioid-induced Constipation Who Require Around-the-clock Opioid Therapy

The primary objectives are to assess the analgesic efficacy of Oxycodone/Naloxone
Controlled-release Tablets (OXN) compared to placebo and to assess the efficacy of OXN for
the management of Opioid-induced Constipation (OIC) compared to Oxycodone Controlled-release
Tablets (OXY) in subjects with moderate to severe pain due to chronic low back pain who
require around-the-clock opioid therapy.


Inclusion Criteria include:

- Male and female subjects ≥ 18 years of age with moderate to severe, chronic low back
pain (lasting at least several hours daily) as their predominant pain condition for
at least 3 months prior to screening period;

- The low back pain must be related to nonmalignant and nonneuropathic conditions and
may be with or without radiation;

- Subjects must have a self-reported history of opioid induced constipation (OIC).

Exclusion Criteria include:

- Subjects with rheumatoid arthritis or other inflammatory arthritis;

- Subjects with neuropathic conditions that have been painful or required therapy
within the past 3 months;

- Subjects with evidence of significant structural abnormalities of the
gastrointestinal (GI) tract or other significant conditions affecting GI motility;

- Subjects with chronic constipation not related to opioid use;

- Subjects who had surgical procedures directed towards the source of chronic low back
pain within 6 months of the screening visit or planned during the study;

- Subjects with a history of malignancy within past 2 years, with exception of basal
cell carcinoma that has been successfully treated.

Other protocol specific inclusion/exclusion criteria may apply.
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