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Opioid Analgesic

Active drug arm for Chronic 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

Study 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 weeks
Treatment ~ Varies
Follow Up ~20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Activity - steps per day
Activity - time sitting
Numberic Rating Scale
+6 more
Secondary outcome measures
Activity
Bayesian analysis
Function
+1 more

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.

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
True Functional Restoration and Analgesia in Non-Radicular Low Back Pain
2022. "True Functional Restoration and Analgesia in Non-Radicular Low Back Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05419297.
All > Low Back Pain > Probuphine
~15 spots leftby Apr 2025
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