Bonipar for Acute and Chronic Musculoskeletal Pain

Study Overview
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Brief Summary
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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
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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%.

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

Conditions
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Chronic Pain, Musculoskeletal Pain

Intervention / Treatment
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* Drug: Bonipar
* Drug: Diclofenac sodium topical solution 1.5%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized to one of two study groups (Bonipar or diclofenac topical solution 1.5%), utilizing a predetermined randomization schedule in a 1:1 ratio.
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced Adverse Effects and/or Complications |  | Up to approximately 1 week |