Bonipar for Acute and Chronic Musculoskeletal Pain

Phase 2

Completed

• Conditions: Chronic Pain; Musculoskeletal Pain
• Interventions: Drug: Diclofenac sodium topical solution 1.5%; Drug: Bonipar

• Registration Number: NCT03471507
• Lead Sponsor: Winston Parris, MD

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 Timeline

• Study First Submitted: 2018-03-14
• Study First Submitted QC: 2018-03-14
• Study First Posted: 2018-03-20
• Study Start: 2020-12-15
• Primary Completion: 2022-09-22
• Study Completion: 2022-09-22
• Status Verified: 2023-08
• Results First Submitted: 2023-08-22
• Results First Submitted QC: 2023-08-22
• Last Update Submitted: 2023-08-22
• Results First Posted: 2023-09-18
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diclofenac topical solution 1.5%	Diclofenac sodium topical solution 1.5%	-
Bonipar	Bonipar	-

Primary Outcome Measures

Name	Time	Method
Change in Pain as Measured by Subjective Pain Intensity Rating (SPIR)	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 Outcome Measures

Name	Time	Method
Number of Participants Who Experienced Adverse Effects and/or Complications	Up to approximately 1 week

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States