Bonipar for Acute and Chronic Musculoskeletal Pain
Condition: Chronic Pain; Musculoskeletal Pain
MeSH terms: Musculoskeletal Pain; Chronic Pain
Intervention: Bonipar; Diclofenac sodium topical solution 1.5%
Intervention description: Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.; Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.
Intervention MeSH terms: Diclofenac
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: 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.
Enrollment: 164.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

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%.
    

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