Efficacy of a Topical Pain Relief Spray Containing Herbal Oil Extracts (Bonipar) Among Individuals With Acute and Chronic Musculoskeletal Pain
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 164
- Locations
- 1
- Primary Endpoint
- Change in Pain as Measured by Subjective Pain Intensity Rating (SPIR)
Study Overview
Brief Summary
This study is a non-inferiority study comparing efficacy and onset of action between the herbal extracts topical solution, Bonipar, and diclofenac sodium topical solution, diclofenac topical solution 1.5%.
Detailed Description
This study is a non-inferiority study comparing efficacy and onset of action between the herbal extracts topical solution, Bonipar, and diclofenac sodium topical solution, diclofenac topical solution 1.5% (approved by the FDA as a topical analgesic). Approximately 168 Duke patients will be recruited from Duke Pain Clinic, and selected Duke primary care practices. Individuals who report acute (less than 3 months duration) or chronic musculoskeletal pain of any intensity will be considered for enrollment into the study. After obtaining consent, eligible subjects will be will be randomized to receive Bonipar or diclofenac topical solution 1.5%.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The bottles will be labelled by pharmacy either "Drug A" or Drug B" according to their designation with a label affixed to cover any drug manufacturing labeling. Only the dispensing pharmacy will not be blinded.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Bonipar
Intervention: Bonipar (Drug)
Diclofenac topical solution 1.5%
Intervention: Diclofenac sodium topical solution 1.5% (Drug)
Outcomes
Primary Outcomes
Change in Pain as Measured by Subjective Pain Intensity Rating (SPIR)
Time Frame: Baseline (approximately 24 hours before consent) to approximately 1 week post administration of study drug (or comparator)
The SPIR is a patient-reported graduated scale where 0 = no pain and 10 = the maximum pain imaginable.
Secondary Outcomes
- Number of Participants Who Experienced Adverse Effects and/or Complications(Up to approximately 1 week)
Investigators
Winston Parris, MD
Professor Emeritus
Duke University