Bonipar for Acute and Chronic Musculoskeletal Pain

NCT ID: NCT03471507

Last Updated: 2023-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2022-09-22

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%.

Conditions

Chronic Pain; Musculoskeletal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bonipar

Group Type: EXPERIMENTAL

Bonipar

Intervention Type: DRUG

Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.

Diclofenac topical solution 1.5%

Group Type: ACTIVE_COMPARATOR

Diclofenac sodium topical solution 1.5%

Intervention Type: DRUG

Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.

Interventions

Bonipar

Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.

Intervention Type: DRUG

Diclofenac sodium topical solution 1.5%

Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Winston Parris, MD

OTHER

Sponsor Role: lead

Responsible Party

Winston Parris, MD

Professor Emeritus

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Lance Roy, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00081546

Identifier Type: -

Identifier Source: org_study_id