Clinical trial NCT03471507: Bonipar for Acute and Chronic Musculoskeletal Pain
Official title: Efficacy of a Topical Pain Relief Spray Containing Herbal Oil Extracts (Bonipar) Among Individuals With Acute and Chronic Musculoskeletal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Pain
Musculoskeletal Pain
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-03-20
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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%.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain as Measured by Subjective Pain Intensity Rating (SPIR)
timeFrame: Baseline (approximately 24 hours before consent) to approximately 1 week post administration of study drug (or comparator)
Secondary outcomes:
measure: Number of Participants Who Experienced Adverse Effects and/or Complications
timeFrame: Up to approximately 1 week
Other outcomes:
measure: Time to the Onset of Action (the First Feeling of 20% Pain Reduction)
timeFrame: Up to 1 hour
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Lance Roy, MD
role: PRINCIPAL_INVESTIGATOR
References: