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 |
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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 |
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.
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.
We found this trial at
198
sites
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