Effect of S-Ibuprofen Gel on Pain in Acute Soft Tissue Contusions
NCT07930559, Phase 3, Recruiting, Aponia Laboratories, Inc.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effect of S-Ibuprofen Gel on Pain in Acute Soft Tissue Contusions | ClinicalTrials.gov |
| NCT number | NCT07930559 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 240 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Aponia Laboratories, Inc. | ClinicalTrials.gov |
| Conditions | Acute Pain Due to Trauma | ClinicalTrials.gov |
| Interventions | S-Ibuprofen Gel 5%, Vehicle Topical Gel | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Evaluation of the efficacy of S-ibuprofen gel 5% applied once every 24 hours compared with placebo in patients with acute contusions of the soft tissues following blunt trauma | 0-24 hours | Change from baseline/pain intensity difference of numerical rating scale (NRS) scores for pain-on-movement at 24 hours. NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Time to first perceptible pain relief based on direct questions to the patient and what they consider perceptible pain relief | From time 0 every 24 hours up to 7 days | Recorded as time in minutes. Optional use of NRS scale. NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Time to onset of meaningful pain relief based on direct questions to the patient and what they consider meaningful pain relief | From time 0 to end of study (day 7) | Recorded as time in minutes. Optional use of NRS scale. NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Time gap between first perceptible pain relief and meaningful pain relief based on direct questions to the patient | From time 0 to end of study (day 7) | Calculated as a difference to reach perceptible vs meaningul pain relief. | ClinicalTrials.gov |
| Secondary | Change from baseline/pain intensity difference of numerical rating scale (NRS) scores for spontaneous pain-on-movement (sPOM) at 24 hours | At 24 hours | Recorded in patient diary based on NRS scores for sPOM at 24 hours. NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Change from baseline for pain-at-rest (PAR) measured by numerical rating scale (NRS) at Visit 2, Visit 3, Visit 4, Visit 5, Visit 6 | At Visit 2 (~24 hours), 3 (~48 hours), 4 (~72 hours), 5 (~96 hours) and 6 (~168 hours) | Based on NRS scores for PAR at 24 hours. NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Change from baseline for pain-on-movement (POM) measured at Visit 3, Visit 4, Visit 5, and Visit 6 | At Visit 3 (~48 hours), 4 (~72 hours), 5 (~96 hours) and 6 (~168 hours) | Based on NRS scores for POM. NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Change from baseline for spontaneous pain-on-movement measured at 6 (±2), 8 (±2), 12 (±2), 16 (±2), 24 (±4), 36 (±4), 48 (±4), 60 (±4), 72 (±4), 84 (±4), 96 (±4), 120 (±4), 144 (±4), and 168 (±24) hours | 6 (±2), 8 (±2), 12 (±2), 16 (±2), 24 (±4), 36 (±4), 48 (±4), 60 (±4), 72 (±4), 84 (±4), 96 (±4), 120 (±4), 144 (±4), and 168 (±24) hours after initial treatment administration | When possible, recorded in patient diary. NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Pain-on-movement at the injured site recorded on a numerical rating scale (NRS) scale in the presence of the investigator for the timepoints at Visit 2, Visit 3, Visit 4, Visit 5, and Visit 6 | At Visit 2 (~24 hours), 3 (~48 hours), 4 (~72 hours), 5 (~96 hours) and 6 (~168 hours) | NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Sum of pain intensity differences (SPIDs) for pain-on-movement at Visit 2, Visit 3, Visit 4, Visit 5, and Visit 6 | At Visit 2 (~24 hours), 3 (~48 hours), 4 (~72 hours), 5 (~96 hours) and 6 (~168 hours) | NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Baseline-adjusted area under the curve (AUC) for pain-on-movement at the injured site recorded on a numerical rating scale (NRS) in the presence of the investigator for the timepoints at Visit 2, Visit 3, Visit 4, Visit 5, and Visit 6 | At Visit 2 (~24 hours), 3 (~48 hours), 4 (~72 hours), 5 (~96 hours) and 6 (~168 hours) | NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Pain at rest measured by a numerical rating scale (NRS) at baseline at Visit 2, Visit 3, Visit 4, Visit 5, and Visit 6 | At Visit 2 (~24 hours), 3 (~48 hours), 4 (~72 hours), 5 (~96 hours) and 6 (~168 hours) | NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Time-specific pain intensity difference for spontaneous pain-on-movement at all time points | Time 0 to end of study (day 7) | Recorded in patient diary. Calculated from NRS scale data generated throughout the study. NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Time-specific pain intensity difference for pain at rest at all time points | Time 0 to end of study (day 7) | Recorded in patient diary. Calculated from NRS scale data generated throughout the study.NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Time-specific pain intensity difference for spontaneous pain on movement at all time points | Time 0 to end of study (day 7) | Recorded in patient diary. Calculated from NRS scale data generated throughout the study. NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Time-specific pain intensity difference for pain at rest at all time points | Time 0 to end of study (day 7) | Recorded in patient diary. Calculated from NRS scale data generated throughout the study. NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Time to complete pain relief (Score = 0 pain) | Time 0 to end of study (day 7) | NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Time to complete resolution of pain-on-movement (Score = 0 pain) | Time 0 to end of study (day 7) | NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Time to complete resolution of pain at rest (Score = 0 of pain) | Time 0 to end of study (day 7) | NRS scale 0-10, 0=no pain, 10=worst possible pain. | ClinicalTrials.gov |
| Secondary | Time to the first request of rescue medication within the first 24 hours | Time 0 to 24 hours | If applicable | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.