Chronic Pain, Musculoskeletal Pain
Conditions
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%.
Interventions
DRUGBonipar
Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.
DRUGDiclofenac 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.
Sponsors
Winston Parris, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, 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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain as Measured by Subjective Pain Intensity Rating (SPIR) | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants Who Experienced Adverse Effects and/or Complications | Up to approximately 1 week |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to the Onset of Action (the First Feeling of 20% Pain Reduction) | Up to 1 hour | Time to the onset of action measured in minutes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bonipar Bonipar: Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period. | 81 |
| Diclofenac Topical Solution 1.5% 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. | 83 |
| Total | 164 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Bonipar | Total | Diclofenac Topical Solution 1.5% |
|---|---|---|---|
| Age, Continuous | 51.5 years STANDARD_DEVIATION 16.6 | 52.8 years STANDARD_DEVIATION 15.9 | 54.2 years STANDARD_DEVIATION 15.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 8 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants | 149 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 6 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 16 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) White | 65 Participants | 130 Participants | 65 Participants |
| Region of Enrollment United States | 81 Participants | 164 Participants | 83 Participants |
| Sex: Female, Male Female | 47 Participants | 99 Participants | 52 Participants |
| Sex: Female, Male Male | 34 Participants | 65 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 83 |
| other Total, other adverse events | 18 / 81 | 21 / 83 |
| serious Total, serious adverse events | 0 / 81 | 0 / 83 |
Outcome results
Primary
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.
Time frame: Baseline (approximately 24 hours before consent) to approximately 1 week post administration of study drug (or comparator)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bonipar | Change in Pain as Measured by Subjective Pain Intensity Rating (SPIR) | -2.3 score on a scale | Standard Deviation 2 |
| Diclofenac Topical Solution 1.5% | Change in Pain as Measured by Subjective Pain Intensity Rating (SPIR) | -2.6 score on a scale | Standard Deviation 1.9 |
p-value: 0.46Regression, Linear
Secondary
Number of Participants Who Experienced Adverse Effects and/or Complications
Time frame: Up to approximately 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bonipar | Number of Participants Who Experienced Adverse Effects and/or Complications | 18 Participants |
| Diclofenac Topical Solution 1.5% | Number of Participants Who Experienced Adverse Effects and/or Complications | 21 Participants |
Other Pre-specified
Time to the Onset of Action (the First Feeling of 20% Pain Reduction)
Time to the onset of action measured in minutes.
Time frame: Up to 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Bonipar | Time to the Onset of Action (the First Feeling of 20% Pain Reduction) | 21 minutes |
| Diclofenac Topical Solution 1.5% | Time to the Onset of Action (the First Feeling of 20% Pain Reduction) | 30 minutes |