Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects
CompletedPhase 3NCT01633944
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
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 purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.
Study details
- Official title
- Phase 3, Double-Blind, Placebo-Controlled, Study to Evaluate the Analgesic Efficacy, Safety, and Tolerability of Buprenorphine HCl Buccal Film in Opioid-Naive Subjects With Chronic Lower Back Pain Requiring Opioid Analgesia
- Conditions
- Interventions
- Sponsor
- BioDelivery Sciences International
- Start date
- 2012-08
- Primary completion
- 2013-12
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 60
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Diagnosis of moderate to severe low back pain for ≥6 months * Treating CLBP with a stable daily maintenance dose of non-opioid analgesic medication up to 10 mg morphine sulfate equivalents (MSE) per day for ≥4 weeks. (Additional as needed \[PRN\] non-opioid analgesic medications permitted on top of the stable daily maintenance dose of non-opioid analgesic) * Stable health, as determined by Principal Investigator * Are female who are practicing abstinence or using a medically acceptable form of contraception or have been post-menopausal, biologically sterile, or surgically sterile for more than 1 year * Willing and able to comply with all protocol required visits and assessments Exclusion Criteria: * Current cancer related pain or received chemotherapy with 6 months of screening * Receiving opioid analgesic medication \>10 mg MSE per day within 28 days of screening * Subjects with a history of other chronic painful conditions * Reflex sympathetic dystrophy or causalgia, acute spinal cord compression, cauda equina compression, acute nerve root compression, meningitis, or discitis * Allergy or contraindications to any opioid or acetaminophen * Surgical procedure for relief of pain with 6 months * Hypokalemia or clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, or active myocardial ischemia * QT interval corrected using Fridericia's formula (QTcF) of ≥450 milliseconds on the 12-lead electrocardiogram (ECG) * History of long QT syndrome or a family member with this condition * Moderate to severe hepatic impairment * Moderate to severe renal impairment * Current or past history of alcohol abuse * Positive urine toxicology screen for drug of abuse * History or abnormalities on physical exam, vital signs, electrocardiogram, or laboratory values
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01633944