Status:
COMPLETED
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
Lead Sponsor:
Purdue Pharma LP
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (OXN) for the management of opioid-induced constipation (OIC) compared with oxycodone controlled-releas...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT01427283
Start Date
August 1 2011
End Date
October 1 2014
Last Update
February 12 2015
Active Locations (149)
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1
Investigational Site
Alabaster, Alabama, United States, 35007
2
Investigational Site
Birmingham, Alabama, United States, 35213
3
Investigational Site
Birmingham, Alabama, United States, 35216
4
Investigational Site
Foley, Alabama, United States, 36535