Bonipar for Acute and Chronic Musculoskeletal Pain

NCT03471507 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Pro00081546
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

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%.

Conditions

Chronic Pain; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain as Measured by Subjective Pain Intensity Rating (SPIR)

  The SPIR is a patient-reported graduated scale where 0 = no pain and 10 = the maximum pain imaginable.

  Baseline (approximately 24 hours before consent) to approximately 1 week post administration of study drug (or comparator)

Secondary Outcomes (1)

• Number of Participants Who Experienced Adverse Effects and/or Complications

  Up to approximately 1 week

Other Outcomes (1)

• Time to the Onset of Action (the First Feeling of 20% Pain Reduction)

  Up to 1 hour

Study Arms (2)

Bonipar

EXPERIMENTAL

Drug: Bonipar

Diclofenac topical solution 1.5%

ACTIVE COMPARATOR

Drug: Diclofenac sodium topical solution 1.5%

Interventions

Bonipar DRUG

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

Bonipar

Diclofenac sodium topical solution 1.5% 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%

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Winston Parris, MD: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Lance Roy, M.D.
• Organization: Duke University Medical Center

lance.roy@duke.edu

919-684-8111

Study Officials

• Lance Roy, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor Emeritus

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2018
• First Posted: March 20, 2018
• Study Start: December 15, 2020
• Primary Completion: September 22, 2022
• Study Completion: September 22, 2022
• Last Updated: September 18, 2023
• Results First Posted: September 18, 2023

Record last verified: 2023-08

Locations

US (1)