Trial · NCT05026320
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.
NCT05026320, Phase 2, Completed, Bayer; results first posted 2025-01-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT05026320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05026320
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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 number
- NCT05026320
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 76 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Soft Tissue Injury
- Interventions
- Naproxen gel, Diclofenac gel, Placebo gel
- First posted
- 2021-08-30
- Last updated
- 2025-01-22
- Other registries' IDs
- eudract:2020-004343-92
- Results first posted
- 2025-01-22
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Tenderness (Algometry) Over the Initial 72 Hours | Up to the initial 72 hours post dose | 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. |
| Secondary | Percentage of Participants With at Least One Treatment Emergent Adverse Event After Treatment | After first treatment on Day 1 until follow-up visit (Day 30) | 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. |
| Secondary | Number of Participants With at Least One Treatment Emergent Adverse Event After Treatment | After first treatment on Day 1 until follow-up visit (Day 30) | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Tenderness (Algometry) Over the Initial 72 Hours | Up to the initial 72 hours post dose | Per protocol population | Nxh/cm^2 | MEAN |
| SECONDARY | Percentage of Participants With at Least One Treatment Emergent Adverse Event After Treatment | After first treatment on Day 1 until follow-up visit (Day 30) | Safety population | Percentage | NUMBER |
| SECONDARY | Number of Participants With at Least One Treatment Emergent Adverse Event After Treatment | After first treatment on Day 1 until follow-up visit (Day 30) | Safety population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Tenderness (Algometry) Over the Initial 72 Hours | Naproxen Topical Gel | 1213.88 | Standard Deviation 461.11 | Nxh/cm^2 | |
| Tenderness (Algometry) Over the Initial 72 Hours | Diclofenac Diethylamine Topical Gel | 1041.04 | Standard Deviation 274.25 | Nxh/cm^2 | |
| Tenderness (Algometry) Over the Initial 72 Hours | Placebo | 850.79 | Standard Deviation 276.04 | Nxh/cm^2 | |
| Percentage of Participants With at Least One Treatment Emergent Adverse Event After Treatment | Naproxen Topical Gel | any AE | 0 | Percentage | |
| Percentage of Participants With at Least One Treatment Emergent Adverse Event After Treatment | Diclofenac Diethylamine Topical Gel | any AE | 3.33 | Percentage | |
| Percentage of Participants With at Least One Treatment Emergent Adverse Event After Treatment | Placebo | any AE | 0 | Percentage | |
| Percentage of Participants With at Least One Treatment Emergent Adverse Event After Treatment | Naproxen Topical Gel | serious AE | 0 | Percentage | |
| Percentage of Participants With at Least One Treatment Emergent Adverse Event After Treatment | Diclofenac Diethylamine Topical Gel | serious AE | 0 | Percentage | |
| Percentage of Participants With at Least One Treatment Emergent Adverse Event After Treatment | Placebo | serious AE | 0 | Percentage | |
| Number of Participants With at Least One Treatment Emergent Adverse Event After Treatment | Naproxen Topical Gel | Rhinitis | 0 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Naproxen Topical Gel | 31 | |
| Overall Study | STARTED | Diclofenac Diethylamine Topical Gel | 30 | |
| Overall Study | STARTED | Placebo | 15 | |
| Overall Study | COMPLETED | Naproxen Topical Gel | 31 | |
| Overall Study | COMPLETED | Diclofenac Diethylamine Topical Gel | 30 | |
| Overall Study | COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | Naproxen Topical Gel | 0 | |
| Overall Study | NOT COMPLETED | Diclofenac Diethylamine Topical Gel | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rhinitis | Infections and infestations | Naproxen Gel | 0 | 31 | 0 |
| other | Rhinitis | Infections and infestations | Diclofenac Gel | 1 | 30 | 1 |
| other | Rhinitis | Infections and infestations | Placebo Gel | 0 | 15 | 0 |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Naproxen Gel | 0 | 31 | 0 |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Diclofenac Gel | 1 | 30 | 1 |
| other | Nasal congestion | Respiratory, thoracic and mediastinal disorders | Placebo Gel | 0 | 15 | 0 |
| other | Paranasal sinus hypersecret | Respiratory, thoracic and mediastinal disorders | Naproxen Gel | 0 | 31 | 0 |
| other | Paranasal sinus hypersecret | Respiratory, thoracic and mediastinal disorders | Diclofenac Gel | 1 | 30 | 1 |
| other | Paranasal sinus hypersecret | Respiratory, thoracic and mediastinal disorders | Placebo Gel | 0 | 15 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Naproxen Gel | 0 | 31 |
| Total, all-cause mortality | Diclofenac Gel | 0 | 30 |
| Total, all-cause mortality | Placebo Gel | 0 | 15 |
| Total, other adverse events | Naproxen Gel | 0 | 31 |
| Total, other adverse events | Diclofenac Gel | 1 | 30 |
| Total, other adverse events | Placebo Gel | 0 | 15 |
| Total, serious adverse events | Naproxen Gel | 0 | 31 |
| Total, serious adverse events | Diclofenac Gel | 0 | 30 |
| Total, serious adverse events | Placebo Gel | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05026320
GET https://conductscience.org/api/trials/v1/NCT05026320/registered