NCT03471507

Bonipar for Acute and Chronic Musculoskeletal Pain

Efficacy of a Topical Pain Relief Spray Containing Herbal Oil Extracts (Bonipar) Among Individuals With Acute and Chronic Musculoskeletal Pain

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: Winston Parris, MD · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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%.

Conditions

• Chronic Pain
• Musculoskeletal Pain

Interventions

Type	Name	Description
DRUG	Bonipar	Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.
DRUG	Diclofenac sodium topical solution 1.5%	Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.

Timeline

• Start date: 2020-12-15
• Primary completion: 2022-09-22
• Completion: 2022-09-22
• First posted: 2018-03-20
• Last updated: 2023-09-18
• Results posted: 2023-09-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study