Clinical Trial Results:
Randomized, Controlled, Double-blind, Placebo-controlled, Multi-center Hypothesis-finding Trial to Compare the Efficacy and Safety of a 10% Naproxen Gel vs. a 2.32% Diclofenac Diethylamine Gel and Placebo in the Treatment of Acute Soft Tissue Injuries of the Lower Extremities
Summary
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EudraCT number |
2020-004343-92 |
Trial protocol |
DE |
Global end of trial date |
20 Dec 2021
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Results information
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Results version number |
v1(current) |
This version publication date |
29 Dec 2022
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First version publication date |
29 Dec 2022
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
BAYH6689/21559
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT05026320 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Bayer AG
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Sponsor organisation address |
Kaiser-Wilhelm-Allee, Leverkusen, Germany, D-51368
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Public contact |
Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.com
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Scientific contact |
Therapeutic Area Head, Bayer AG, +49 30 300139003, clinical-trials-contact@bayer.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
22 Feb 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Dec 2021
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To assess the effectivenss of a naproxen topical gel 10%, diclofenac diethylamine 2.32% and placebo for relieving tenderness to pressure in subjects with acute soft tissue injuries of the lower extremities.
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Protection of trial subjects |
The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with ethical principles that have their origin in the Declaration of Helsinki and the International Council for Harmonization guideline E6: Good Clinical Practice. Before entering the study, the informed consent was read by and explained to all the subjects. Participating subjects signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
08 Aug 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 76
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Worldwide total number of subjects |
76
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EEA total number of subjects |
76
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
76
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
The study was conducted in three centers in Germany. First subject first visit of the study was on 08 AUG 2021, and last subject last visit was on 20 DEC 2021. | ||||||||||||
Pre-assignment
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Screening details |
Overall 76 subjects completed screening and were randomized. | ||||||||||||
Period 1
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Period 1 title |
Overall (overall period)
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Carer, Data analyst, Assessor | ||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Naproxen Topical Gel | ||||||||||||
Arm description |
Subjects received naproxen topical gel twice daily for 5 days. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Naproxen Gel
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Investigational medicinal product code |
BAYH6689
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Other name |
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Pharmaceutical forms |
Gel
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Routes of administration |
Topical use
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Dosage and administration details |
Twice a day (BID) for 5 days (final application on morning of Day 6)
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Arm title
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Diclofenac Diethylamine Topical Gel | ||||||||||||
Arm description |
Subjects received diclofenac diethylamine topical gel twice daily for 5 days. | ||||||||||||
Arm type |
Active comparator | ||||||||||||
Investigational medicinal product name |
Diclofenac Gel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Gel
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Routes of administration |
Topical use
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Dosage and administration details |
Twice a day (BID) for 5 days (final application on morning of Day 6)
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Arm title
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Placebo | ||||||||||||
Arm description |
Subjects received placebo twice daily for 5 days. | ||||||||||||
Arm type |
Placebo | ||||||||||||
Investigational medicinal product name |
Placebo Gel
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Gel
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Routes of administration |
Topical use
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Dosage and administration details |
Twice a day (BID) for 5 days (final application on morning of Day 6)
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Baseline characteristics reporting groups
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Reporting group title |
Naproxen Topical Gel
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Reporting group description |
Subjects received naproxen topical gel twice daily for 5 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Diclofenac Diethylamine Topical Gel
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Reporting group description |
Subjects received diclofenac diethylamine topical gel twice daily for 5 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Subjects received placebo twice daily for 5 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Naproxen Topical Gel
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Reporting group description |
Subjects received naproxen topical gel twice daily for 5 days. | ||
Reporting group title |
Diclofenac Diethylamine Topical Gel
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Reporting group description |
Subjects received diclofenac diethylamine topical gel twice daily for 5 days. | ||
Reporting group title |
Placebo
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Reporting group description |
Subjects received placebo twice daily for 5 days. | ||
Subject analysis set title |
Safety population
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The safety population included all randomized patients who received at least one dose of the study treatment.
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Subject analysis set title |
Intent to treat (ITT)/Full Analysis Set (FAS)
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All subjects who were randomized and provided at least one measure of primary efficacy parameter after the first application of the study treatment.
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Subject analysis set title |
Per protocol population (PP)
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
The Per Protocol population included all subjects in Intent to treat (ITT) who completed the study and did not have any major protocol violations.
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End point title |
Tenderness (algometry) over the initial 72 hours | ||||||||||||||||
End point description |
Algometry area under the curve (AUC) from zero to 72h post dose
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End point type |
Primary
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End point timeframe |
Up to 72 hours post dose
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Notes [1] - Per protocol population [2] - Per protocol population [3] - Per protocol population |
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Statistical analysis title |
Analysis of Covariance (ANCOVA) | ||||||||||||||||
Comparison groups |
Naproxen Topical Gel v Diclofenac Diethylamine Topical Gel v Placebo
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Number of subjects included in analysis |
72
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||||||
P-value |
= 0.0221 | ||||||||||||||||
Method |
ANCOVA | ||||||||||||||||
Confidence interval |
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End point title |
Percentage of subjects with at least one treatment emergent adverse event after treatment | ||||||||||||||||||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
After first treatment on Day 1 until follow-up visit (Day 30)
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Notes [4] - Safety population [5] - Safety population [6] - Safety population |
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No statistical analyses for this end point |
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End point title |
Number of subjects with at least one treatment emergent adverse event after treatment | ||||||||||||||||||||||||
End point description |
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.
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End point type |
Secondary
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End point timeframe |
After first treatment on Day 1 until follow-up visit (Day 30)
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Notes [7] - Safety population [8] - Safety population [9] - Safety population |
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Adverse event data were collected after first treatment on Day 1 until follow-up visit (Day 30).
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.0
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Reporting groups
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Reporting group title |
Naxopren Gel
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Reporting group description |
Participants received Naxopren topical gel (BAYH006689) two times a day (bid) for 5 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo Gel
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Reporting group description |
Participants received Placebo gel bid for 5 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Diclofenac Gel
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Reporting group description |
Participants received Diclofenac Diethylamine gel bid for 5 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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09 Nov 2021 |
Amendment 3 specified following modifications: Exclusion Criteria, Statistical Hypotheses, Sample Size Determination, Analysis Sets – Per Protocol, Statistical Analysis |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |