A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain
CompletedPhase 3NCT01571362
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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 of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.
Study details
- Official title
- A Multicenter, 12 Week, Double-blind, Placebo-controlled, Randomized Withdrawal Study To Determine The Efficacy And Safety Of Alo-02 (Oxycodone Hydrochloride And Naltrexone Hydrochloride) Extended-release Capsules In Subjects With Moderate To Severe Chronic Low Back Pain
- Conditions
- Interventions
- Drug: ALO-02
- Drug: Placebo
- Sponsor
- Pfizer
- Start date
- 2012-06
- Primary completion
- 2013-06
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 52
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Moderate-to-severe chronic low back pain present for at least 3 months. * Require a continuous around-the-clock opioid analgesic for an extended period of time. * Refrain from taking other opioid and non-opioid medications during the study. Exclusion Criteria: * Active or within a past 2 years a history of lumbosacral radiculopathy or chronic low back pain due to other underlying disorders such as spinal stenosis with neurologic impairment, cancer, infection, or post-surgical intervention. * Documented diagnosis of ongoing pain due to other chronic pain conditions which may interfere with assessment of chronic low back pain. * Active or ongoing or history of alcohol or drug abuse.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01571362