Bonipar for Acute and Chronic Musculoskeletal Pain

Winston Parris, MD

Status and phase

Completed

Phase 2

Conditions

Musculoskeletal Pain

Chronic Pain

Treatments

Drug: Diclofenac sodium topical solution 1.5%

Drug: Bonipar

Study type

Interventional

Funder types

Other

Identifiers

NCT03471507

Pro00081546

Details and patient eligibility

About

Full 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%.

Enrollment

164 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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