Chronic PainPhase 2NCT03471507
Bonipar for Acute and Chronic Musculoskeletal Pain
A Phase 2 study testing Bonipar and Diclofenac sodium topical solution 1.5% in people with Chronic Pain and Musculoskeletal Pain, run by Winston Parris, MD at 1 site in United States.
Trial 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%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain, Musculoskeletal Pain
- What is being tested?
- Bonipar and Diclofenac sodium topical solution 1.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 22 Sep 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Efficacy of a Topical Pain Relief Spray Containing Herbal Oil Extracts (Bonipar) Among Individuals With Acute and Chronic Musculoskeletal Pain
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%.
Read the 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
- Being tested
- Bonipar, Diclofenac sodium topical solution 1.5%
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoniparDrug
Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.
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.
| Study group | Role | What they receive |
|---|---|---|
| Bonipar | Experimental | Not described Receives: Drug: Bonipar |
| Diclofenac topical solution 1.5% | Active comparator | Not described Receives: Drug: Diclofenac sodium topical solution 1.5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Up to approximately 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start15 Dec 2020
- Primary completion22 Sep 2022
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Winston Parris, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Winston Parris, MD, Duke University
- Investigators
- Lance Roy, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471507
- Sponsor's protocol ID
- Pro00081546
- Status last verified
- Aug 2023
- First submitted
- 14 Mar 2018
- Last updated
- 18 Sep 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Topical Pain Relief Spray Containing Herbal Oil Extracts (Bonipar) Among Individuals With Acute and Chronic Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT03471507
- Acronym / sponsor ID
- Pro00081546
- Conditions
- Chronic Pain, Musculoskeletal Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Winston Parris, MDUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 20 Mar 2018 (actual)
- Results
- Posted 18 Sep 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bonipar | Experimental | Drug: Bonipar |
| Diclofenac topical solution 1.5% | Active comparator | Drug: Diclofenac sodium topical solution 1.5% |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BoniparApply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period. | Drug | Bonipar |
| 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. | Drug | Diclofenac topical solution 1.5% |
Primary outcome
Change in Pain as Measured by Subjective Pain Intensity Rating (SPIR)
Time frame: Baseline (approximately 24 hours before consent) to approximately 1 week post administration of study drug (or comparator)
The SPIR is a patient-reported graduated scale where 0 = no pain and 10 = the maximum pain imaginable.
1 secondary outcome
Number of Participants Who Experienced Adverse Effects and/or Complications
Time frame: Up to approximately 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lance Roy, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bonipar and Diclofenac sodium topical solution 1.5% in people with Chronic Pain and Musculoskeletal Pain, run by Winston Parris, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain as Measured by Subjective Pain Intensity Rating (SPIR) (time frame: Baseline (approximately 24 hours before consent) to approximately 1 week post administration of study drug (or comparator)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.