Overview

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
Trial end date:
2014-10-01
Target enrollment:
0
Participant gender:
All
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-release tablets (OXY) in subjects with moderate to severe low back pain and opioid-induced constipation who require around-the-clock opioid therapy.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Purdue Pharma LP
Treatments:
Analgesics
Analgesics, Opioid
Naloxone
Oxycodone
Criteria
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.