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Bonipar for Acute and Chronic Musculoskeletal Pain

Primary Purpose

Chronic Pain, Musculoskeletal Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bonipar
Diclofenac sodium topical solution 1.5%
Sponsored by
Winston Parris, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bonipar

Diclofenac topical solution 1.5%

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Participants Who Experienced Adverse Effects and/or Complications

Full Information

First Posted
March 14, 2018
Last Updated
August 22, 2023
Sponsor
Winston Parris, MD
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1. Study Identification

Unique Protocol Identification Number
NCT03471507
Brief Title
Bonipar for Acute and Chronic Musculoskeletal Pain
Official Title
Efficacy of a Topical Pain Relief Spray Containing Herbal Oil Extracts (Bonipar) Among Individuals With Acute and Chronic Musculoskeletal Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2020 (Actual)
Primary Completion Date
September 22, 2022 (Actual)
Study Completion Date
September 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Winston Parris, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Musculoskeletal Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bonipar
Arm Type
Experimental
Arm Title
Diclofenac topical solution 1.5%
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Bonipar
Intervention Description
Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.
Intervention Type
Drug
Intervention Name(s)
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.
Primary Outcome Measure Information:
Title
Change in Pain as Measured by Subjective Pain Intensity Rating (SPIR)
Description
The SPIR is a patient-reported graduated scale where 0 = no pain and 10 = the maximum pain imaginable.
Time Frame
Baseline (approximately 24 hours before consent) to approximately 1 week post administration of study drug (or comparator)
Secondary Outcome Measure Information:
Title
Number of Participants Who Experienced Adverse Effects and/or Complications
Time Frame
Up to approximately 1 week
Other Pre-specified Outcome Measures:
Title
Time to the Onset of Action (the First Feeling of 20% Pain Reduction)
Description
Time to the onset of action measured in minutes.
Time Frame
Up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lance Roy, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Bonipar for Acute and Chronic Musculoskeletal Pain

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