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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

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 weeks for reporting.

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 more

Secondary study objectives

Activity

Bayesian analysis

Function

+1 more

Awards & 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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