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Bonipar for Acute and Chronic Musculoskeletal Pain

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ClinicalTrials.gov Identifier: NCT03471507
Recruitment Status : Not yet recruiting
First Posted : March 20, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Winston Parris, MD, Duke University Medical Center

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 gel 1%.

Condition or disease Intervention/treatment Phase
Chronic Pain Musculoskeletal Pain Drug: Bonipar Drug: Diclofenac sodium gel 1% Phase 1

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 gel 1% (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 gel 1%.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to one of two study groups (Bonipar or diclofenac gel 1%), 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.
Primary Purpose: Treatment
Official Title: Efficacy of a Topical Pain Relief Spray Containing Herbal Oil Extracts (Bonipar) Among Individuals With Acute and Chronic Musculoskeletal Pain
Estimated Study Start Date : May 31, 2018
Estimated Primary Completion Date : April 15, 2020
Estimated Study Completion Date : April 15, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Bonipar Drug: Bonipar
Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.
Active Comparator: Diclofenac gel 1% Drug: Diclofenac sodium gel 1%
Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.



Primary Outcome Measures :
  1. Change over time of SPIR pain score from 24 hours prior to signing consent to 1 week after administration of study drug or active comparator [ Time Frame: Change of reported pain from approximately 24 hours before consent to approximately 1 week post administration of study drug (or comparator) ]
    Subjective Pain Intensity Rating (SPIR) will be used, a patient-reported graduated scale where 0 = no pain and 10 = the maximum pain imaginable.


Secondary Outcome Measures :
  1. Adverse Effects/Complications [ Time Frame: Up to approximately 1 week ]

Other Outcome Measures:
  1. Time of Onset of Action of Bonipar measurement [ Time Frame: Up to 1 hour ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471507


Contacts
Contact: Lance Roy, MD 919-668-7246 lindsay.waters@dm.duke.edu
Contact: Alicja Szydlowska +1 919 681 4377 alicja.szydlowska@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Lance Roy, MD       lindsay.waters@dm.duke.edu   
Sponsors and Collaborators
Winston Parris, MD
Investigators
Principal Investigator: Lance Roy, MD Duke University

Responsible Party: Winston Parris, MD, Professor Emeritus, Duke University Medical Center
ClinicalTrials.gov Identifier: NCT03471507     History of Changes
Other Study ID Numbers: Pro00081546
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chronic Pain
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action