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

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%.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain; Chronic Pain
• Intervention / Treatment: Drug: Bonipar; Drug: Diclofenac sodium 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 Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

INCLUSIONARY CRITERIA:

• Subject with acute and chronic localized musculoskeletal pain
• Ages 18 to 80 years
• Subjects of all races, gender or ethnic groups
• Female subjects of childbearing age must have a negative pregnancy test Female subjects of childbearing age who are sexually active must agree to use appropriate contraceptive measures for the duration of the study. Medically acceptable contraceptives include: (1) surgical sterilization (such as tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD).
• Willing to provide written informed consent
• Patients taking opioid or NSAID for their musculoskeletal pain may be included if pain is inadequately controlled

EXCLUSIONARY CRITERIA:

• Patients meeting any of the following criteria will be excluded from the study: Use within 3 days of any topical agents on the affected area
• Subject with active skin lesions or skin disease or with cutaneous manifestations of systemic illnesses
• Subject with history of uncontrolled diabetes (A1C of more than 9)
• Subject with history of uncontrolled hypertension (SBP > 160 and DBP > 95)
• Subject with active uncontrolled GERD (defined as more than 2 episodes per week) or history of peptic ulcer disease
• Subject with active cancer, spinal cord lesions or spine surgery
• Subject with allergies to diclofenac or to other non-steroid anti-inflammatory drugs (NSAID)
• Known allergies to any oils, methyl salicylate and/or camphor
• Subject is pregnant or lactating
• Subject with history of heart attack, stroke or blood clot, or recent coronary artery bypass graft surgery (CABG) (i.e., within the last six months)
• Subject with history of alcohol or drug abuse within 1 year
• Subject with history of severe cardiac, liver or kidney disease or any other medical condition that may interfere with the subject's ability to participate in the study as determined by the Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bonipar	Drug: Bonipar; Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.
Active Comparator: Diclofenac topical solution 1.5%	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain as Measured by Subjective Pain Intensity Rating (SPIR)	The SPIR is a patient-reported graduated scale where 0 = no pain and 10 = the maximum pain imaginable.	Baseline (approximately 24 hours before consent) to approximately 1 week post administration of study drug (or comparator)

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants Who Experienced Adverse Effects and/or Complications	Up to approximately 1 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the Onset of Action (the First Feeling of 20% Pain Reduction)	Time to the onset of action measured in minutes.	Up to 1 hour

Collaborators and Investigators

• Sponsor: Winston Parris, MD
• Investigators: Principal Investigator: Lance Roy, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): September 22, 2022
• Study Completion (Actual): September 22, 2022

Study Registration Dates

• First Submitted: March 14, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 20, 2018

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Chronic Pain; Musculoskeletal Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Diclofenac
• Other Study ID Numbers: Pro00081546

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No