Trial Outcomes & Findings for Bonipar for Acute and Chronic Musculoskeletal Pain (NCT NCT03471507)
NCT ID: NCT03471507
Last Updated: 2023-09-18
Results Overview
The SPIR is a patient-reported graduated scale where 0 = no pain and 10 = the maximum pain imaginable.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
164 participants
Primary outcome timeframe
Baseline (approximately 24 hours before consent) to approximately 1 week post administration of study drug (or comparator)
Results posted on
2023-09-18
Participant Flow
Participant milestones
| Measure |
Bonipar
Bonipar: 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%
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.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
83
|
|
Overall Study
COMPLETED
|
78
|
78
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Bonipar
Bonipar: 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%
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Bonipar for Acute and Chronic Musculoskeletal Pain
Baseline characteristics by cohort
| Measure |
Bonipar
n=81 Participants
Bonipar: 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%
n=83 Participants
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.
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.5 years
STANDARD_DEVIATION 16.6 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 15.1 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
81 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Bonipar
n=81 Participants
Bonipar: 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%
n=83 Participants
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.
|
|---|---|---|
|
Change in Pain as Measured by Subjective Pain Intensity Rating (SPIR)
|
-2.3 score on a scale
Standard Deviation 2.0
|
-2.6 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Up to approximately 1 weekOutcome measures
| Measure |
Bonipar
n=81 Participants
Bonipar: 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%
n=83 Participants
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.
|
|---|---|---|
|
Number of Participants Who Experienced Adverse Effects and/or Complications
|
18 Participants
|
21 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 hourTime to the onset of action measured in minutes.
Outcome measures
| Measure |
Bonipar
n=81 Participants
Bonipar: 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%
n=83 Participants
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.
|
|---|---|---|
|
Time to the Onset of Action (the First Feeling of 20% Pain Reduction)
|
21 minutes
Interval 15.0 to 45.0
|
30 minutes
Interval 15.0 to 45.0
|
Adverse Events
Bonipar
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Diclofenac Topical Solution 1.5%
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bonipar
n=81 participants at risk
Bonipar: 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%
n=83 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Change in blood pressure
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
Cardiac disorders
Dizziness and increased heart rate
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
Ear and labyrinth disorders
Mild tinnitus
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
Eye disorders
Eye irritation
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
Gastrointestinal disorders
Diarrhea with blood in the stool
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
Gastrointestinal disorders
GI discomfort
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
General disorders
Dysgeusia
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
General disorders
Epistaxis
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
General disorders
Head Congestion
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
General disorders
Headache
|
1.2%
1/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
General disorders
Increase in leg (calf and thigh) pain
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
General disorders
Increase weakness in leg
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
General disorders
Leg Discomfort
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
General disorders
Lump formation in right hand
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
General disorders
Lump formation on left thumb
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
General disorders
Metallic taste
|
1.2%
1/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
General disorders
Migraine
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
General disorders
Nasal Congestion
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
General disorders
Neck pain
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
General disorders
Radiating shoulder pain
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
General disorders
Rhinorrhea
|
1.2%
1/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
General disorders
Right upper eyelid twitch
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
General disorders
Sneezing
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
General disorders
Treatment site swollen
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
Musculoskeletal and connective tissue disorders
Abdominal Muscle Spasm
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
Nervous system disorders
Altered Gait
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
Nervous system disorders
Dysesthesia
|
1.2%
1/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
Nervous system disorders
Dysesthesia/Numbness
|
1.2%
1/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
Nervous system disorders
Numbness
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
Nervous system disorders
Tingling in foot and calf of treated leg
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
Nervous system disorders
Tingling in left hand
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
Nervous system disorders
Tingling toes in treated ankle
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
Psychiatric disorders
Vivid Dreams
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
Respiratory, thoracic and mediastinal disorders
Allergies
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
Respiratory, thoracic and mediastinal disorders
Cough/congestion
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
Skin and subcutaneous tissue disorders
Dryness
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
Skin and subcutaneous tissue disorders
Dryness around freckle
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/81 • Up to approximately 1 week
|
4.8%
4/83 • Up to approximately 1 week
|
|
Skin and subcutaneous tissue disorders
Mild skin irritation
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
Skin and subcutaneous tissue disorders
Pruritic Palms
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
Skin and subcutaneous tissue disorders
Rash on both sides of neck
|
1.2%
1/81 • Up to approximately 1 week
|
0.00%
0/83 • Up to approximately 1 week
|
|
Skin and subcutaneous tissue disorders
Redness
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
Skin and subcutaneous tissue disorders
Redness along wrist
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
|
Skin and subcutaneous tissue disorders
Redness on shoulder
|
0.00%
0/81 • Up to approximately 1 week
|
1.2%
1/83 • Up to approximately 1 week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place