Trial Outcomes & Findings for A Clinical Trial to Compare Safety and Effectiveness for Relieving Tenderness of 10% Naproxen Gel vs. a 2.32% Diclofenac Diethylamine Gel in the Treatment of Strains and Bruises of the Legs. (NCT NCT05026320)
NCT ID: NCT05026320
Last Updated: 2025-01-22
Results Overview
Algometry area under the curve (AUC) from zero to the initial 72h post dose. The 72h AUC algometry data was an aggregate of all measurements from timepoints and data including the 72h timepoint. The average data of all participants was reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
Up to the initial 72 hours post dose
Results posted on
2025-01-22
Participant Flow
The study was conducted in three centers in Germany. First participant first visit of the study was on 08 AUG 2021, and last participant last visit was on 20 DEC 2021.
Overall 76 participants completed screening and were randomized.
Participant milestones
| Measure |
Naproxen Topical Gel
Participants received naproxen topical gel twice daily for 5 days.
|
Diclofenac Diethylamine Topical Gel
Participants received diclofenac diethylamine topical gel twice daily for 5 days.
|
Placebo
Participants received placebo twice daily for 5 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
15
|
|
Overall Study
COMPLETED
|
31
|
30
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Trial to Compare Safety and Effectiveness for Relieving Tenderness of 10% Naproxen Gel vs. a 2.32% Diclofenac Diethylamine Gel in the Treatment of Strains and Bruises of the Legs.
Baseline characteristics by cohort
| Measure |
Naproxen Topical Gel
n=31 Participants
Participants received naproxen topical gel twice daily for 5 days.
|
Diclofenac Diethylamine Topical Gel
n=30 Participants
Participants received diclofenac diethylamine topical gel twice daily for 5 days.
|
Placebo
n=15 Participants
Participants received placebo twice daily for 5 days.
|
Total
n=76 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.32 years
STANDARD_DEVIATION 10.74 • n=5 Participants
|
31.57 years
STANDARD_DEVIATION 9.47 • n=7 Participants
|
32.47 years
STANDARD_DEVIATION 13.05 • n=5 Participants
|
32.46 years
STANDARD_DEVIATION 10.64 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
41 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic/Latino
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to the initial 72 hours post dosePopulation: Per protocol population
Algometry area under the curve (AUC) from zero to the initial 72h post dose. The 72h AUC algometry data was an aggregate of all measurements from timepoints and data including the 72h timepoint. The average data of all participants was reported.
Outcome measures
| Measure |
Naproxen Topical Gel
n=30 Participants
Participants received naproxen topical gel twice daily for 5 days.
|
Diclofenac Diethylamine Topical Gel
n=28 Participants
Participants received diclofenac diethylamine topical gel twice daily for 5 days.
|
Placebo
n=14 Participants
Participants received placebo twice daily for 5 days.
|
|---|---|---|---|
|
Tenderness (Algometry) Over the Initial 72 Hours
|
1213.88 Nxh/cm^2
Standard Deviation 461.11
|
1041.04 Nxh/cm^2
Standard Deviation 274.25
|
850.79 Nxh/cm^2
Standard Deviation 276.04
|
SECONDARY outcome
Timeframe: After first treatment on Day 1 until follow-up visit (Day 30)Population: Safety population
An AE is any untoward medical occurrence in a clinical study participant, associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Naproxen Topical Gel
n=31 Participants
Participants received naproxen topical gel twice daily for 5 days.
|
Diclofenac Diethylamine Topical Gel
n=30 Participants
Participants received diclofenac diethylamine topical gel twice daily for 5 days.
|
Placebo
n=15 Participants
Participants received placebo twice daily for 5 days.
|
|---|---|---|---|
|
Percentage of Participants With at Least One Treatment Emergent Adverse Event After Treatment
any AE
|
0 Percentage
|
3.33 Percentage
|
0 Percentage
|
|
Percentage of Participants With at Least One Treatment Emergent Adverse Event After Treatment
serious AE
|
0 Percentage
|
0 Percentage
|
0 Percentage
|
SECONDARY outcome
Timeframe: After first treatment on Day 1 until follow-up visit (Day 30)Population: Safety population
An AE is any untoward medical occurrence in a clinical study participant, associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Naproxen Topical Gel
n=31 Participants
Participants received naproxen topical gel twice daily for 5 days.
|
Diclofenac Diethylamine Topical Gel
n=30 Participants
Participants received diclofenac diethylamine topical gel twice daily for 5 days.
|
Placebo
n=15 Participants
Participants received placebo twice daily for 5 days.
|
|---|---|---|---|
|
Number of Participants With at Least One Treatment Emergent Adverse Event After Treatment
Rhinitis
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With at Least One Treatment Emergent Adverse Event After Treatment
Nasal congestion
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With at Least One Treatment Emergent Adverse Event After Treatment
Paranasal sinus hypersecretion
|
0 Participants
|
1 Participants
|
0 Participants
|
Adverse Events
Naproxen Gel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Diclofenac Gel
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo Gel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naproxen Gel
n=31 participants at risk
Participants received Naproxen topical gel (BAYH006689) two times a day (bid) for 5 days.
|
Diclofenac Gel
n=30 participants at risk
Participants received Diclofenac Diethylamine gel bid for 5 days.
|
Placebo Gel
n=15 participants at risk
Participants received Placebo gel bid for 5 days.
|
|---|---|---|---|
|
Infections and infestations
Rhinitis
|
0.00%
0/31 • Adverse event data were collected after first treatment on Day 1 until follow-up visit (Day 30).
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected after first treatment on Day 1 until follow-up visit (Day 30).
|
0.00%
0/15 • Adverse event data were collected after first treatment on Day 1 until follow-up visit (Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/31 • Adverse event data were collected after first treatment on Day 1 until follow-up visit (Day 30).
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected after first treatment on Day 1 until follow-up visit (Day 30).
|
0.00%
0/15 • Adverse event data were collected after first treatment on Day 1 until follow-up visit (Day 30).
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecret
|
0.00%
0/31 • Adverse event data were collected after first treatment on Day 1 until follow-up visit (Day 30).
|
3.3%
1/30 • Number of events 1 • Adverse event data were collected after first treatment on Day 1 until follow-up visit (Day 30).
|
0.00%
0/15 • Adverse event data were collected after first treatment on Day 1 until follow-up visit (Day 30).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigator (PI) agrees to submit any proposed publication, abstract or presentation related to the Study ("Publication") to Sponsor at least 30 days prior to submission. Sponsor shall advise PI or Designee in writing of any information that is Confidential Information (CI) or Sponsor's Intellectual Property (SIP). Sponsor shall have the right to require PI or Designee, to remove CI and/or delay the Publication for an additional 60 days to enable Sponsor to seek protection of SIP.
- Publication restrictions are in place
Restriction type: OTHER