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Opioid Analgesic
True Functional Restoration and Analgesia in Non-Radicular Low Back Pain
Phase 4
Recruiting
Led By AMANDA A ZIMMERMAN, PA-C
Research Sponsored by Carolinas Pain Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial is designed to study the response of objective and quasi-objective 'True' functional outcomes, analgesia and safety in chronic non-radicular back pain to buprenorphine buccal film (BBF) using a small 'n' phase IV design.
Eligible Conditions
- Chronic Pain
- Chronic Lower Back Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Activity - steps per day
Activity - time sitting
Numberic Rating Scale
+6 moreSecondary study objectives
Activity
Bayesian analysis
Function
+1 moreAwards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active drug armActive Control8 Interventions
Subjects who meet eligibility criteria and complete a single blind placebo lead in will be provided placebo buprenorphine buccal film that mimics the actual drug comparator and is continued by a blinded individual throughout the duration of the trial.
Group II: Placebo armPlacebo Group7 Interventions
Subjects who meet eligibility criteria and complete a single blind placebo lead in will be provided active buprenorphine buccal film that is titrated to the effective dose and continued by a blinded individual throughout the duration of the trial.
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Who is running the clinical trial?
BioDelivery Sciences InternationalIndustry Sponsor
21 Previous Clinical Trials
39,748 Total Patients Enrolled
1 Trials studying Chronic Pain
302 Patients Enrolled for Chronic Pain
Carolinas Pain InstituteLead Sponsor
AMANDA A ZIMMERMAN, PA-CPrincipal InvestigatorWest Forsyth Pain Management