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
CompletedPhase 3NCT01427283
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- Interventions
- Drug: Oxycodone/Naloxone controlled-release
- Drug: Oxycodone HCl controlled-release
- Drug: Placebo
- Sponsor
- Purdue Pharma LP
- Start date
- 2011-08
- Primary completion
- 2014-10
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 149
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01427283