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

Pro00081546

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%.

2020-12-15

2022-09-22

2022-09-22

Completed

Early phase I

164

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'The bottles will be labelled by pharmacy either "Drug A" or Drug B" according to their designation with a label affixed to cover any drug manufacturing labeling. Only the dispensing pharmacy will not be blinded.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 164, 'type': 'ACTUAL'}}

2023-09-18