A Phase 3 interventional study of S-Ibuprofen Gel 5% and Vehicle Topical Gel in Acute Pain Due to Trauma, sponsored by Aponia Laboratories, Inc.. Recruiting at 6 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Aponia Laboratories, Inc. · Phase 3, Interventional, and Treatment
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Among 11 studies in Contusions with a site in United States — 1 open to participants now, 1 under way, 1 of them phase 3. Contusions · United States.
Among the 11 studies in Contusions with a site in United States, this one is the only one that started in 2026, is one of 4 in phase 3, and was the 11th registered.
44 studies on the registry are indexed under Contusions; 9 are open to participants now.
Browse Contusions studies →1 of the 11 studies in Contusions with a site in United States is open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 5 Contusions studies recruiting now, 4 set no upper age limit and 1 stops at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
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11 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 240 is above the median of 95 across 32 interventional studies indexed under Contusions.
Median enrollment 28 across the 9 interventional studies, 68 across the 2 observational. Of the 8 that completed or were terminated, 7 (88%) have results posted.
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4 of 11 have an industry lead sponsor. The 10 most frequent:
Aponia Laboratories, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Aponia Laboratories, Inc. has 1 study filed under Contusions — fewer than ten, so there is no comparison to draw.
1 of the studies in Contusions with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07930559Phase 3Aponia Laboratories, Inc.Effect of S-Ibuprofen Gel on Pain in Acute Soft Tissue Contusions | 2027-06 |
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Among the 11 studies in Contusions with a site in United States, from their registry updates:
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Phase 3 study designed to evaluated analgesic efficacy and safety of S-Ibuprofen Topical Gel 5%
The purpose of this randomized, double-blind study is to evaluate the efficacy and safety of S-Ibuprofen Topical Gel 5% in treatment of pain in acute contusions of the soft tissues following blunt trauma.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
S-Ibuprofen Topical Gel 5% applied once per day to the affected injury site
Drug: S-Ibuprofen Gel 5%
Placebo Gel applied once per day to the affected injury site
Drug: Vehicle Topical Gel
Topical gel containing active ingredient S-ibuprofen
Placebo gel matching the active comparator in conposition and appearance without the active ingredient
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
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.
Time frame: 0-24 hours
Time to first perceptible pain relief based on direct questions to the patient and what they consider perceptible pain relief
Recorded as time in minutes. Optional use of NRS scale. NRS scale 0-10, 0=no pain, 10=worst possible pain.
Time frame: From time 0 every 24 hours up to 7 days
Time to onset of meaningful pain relief based on direct questions to the patient and what they consider meaningful pain relief
Recorded as time in minutes. Optional use of NRS scale. NRS scale 0-10, 0=no pain, 10=worst possible pain.
Time frame: From time 0 to end of study (day 7)
Time gap between first perceptible pain relief and meaningful pain relief based on direct questions to the patient
Calculated as a difference to reach perceptible vs meaningul pain relief.
Time frame: From time 0 to end of study (day 7)
Change from baseline/pain intensity difference of numerical rating scale (NRS) scores for spontaneous pain-on-movement (sPOM) 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.
Time frame: At 24 hours
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
Based on NRS scores for PAR at 24 hours. NRS scale 0-10, 0=no pain, 10=worst possible pain.
Time frame: At Visit 2 (~24 hours), 3 (~48 hours), 4 (~72 hours), 5 (~96 hours) and 6 (~168 hours)
Change from baseline for pain-on-movement (POM) measured at Visit 3, Visit 4, Visit 5, and Visit 6
Based on NRS scores for POM. NRS scale 0-10, 0=no pain, 10=worst possible pain.
Time frame: At Visit 3 (~48 hours), 4 (~72 hours), 5 (~96 hours) and 6 (~168 hours)
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
When possible, recorded in patient diary. NRS scale 0-10, 0=no pain, 10=worst possible pain.
Time frame: 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
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
NRS scale 0-10, 0=no pain, 10=worst possible pain.
Time frame: At Visit 2 (~24 hours), 3 (~48 hours), 4 (~72 hours), 5 (~96 hours) and 6 (~168 hours)
Sum of pain intensity differences (SPIDs) for pain-on-movement at Visit 2, Visit 3, Visit 4, Visit 5, and Visit 6
NRS scale 0-10, 0=no pain, 10=worst possible pain.
Time frame: At Visit 2 (~24 hours), 3 (~48 hours), 4 (~72 hours), 5 (~96 hours) and 6 (~168 hours)
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
NRS scale 0-10, 0=no pain, 10=worst possible pain.
Time frame: At Visit 2 (~24 hours), 3 (~48 hours), 4 (~72 hours), 5 (~96 hours) and 6 (~168 hours)
Pain at rest measured by a numerical rating scale (NRS) at baseline at Visit 2, Visit 3, Visit 4, Visit 5, and Visit 6
NRS scale 0-10, 0=no pain, 10=worst possible pain.
Time frame: At Visit 2 (~24 hours), 3 (~48 hours), 4 (~72 hours), 5 (~96 hours) and 6 (~168 hours)
Time-specific pain intensity difference for spontaneous pain-on-movement at all time points
Recorded in patient diary. Calculated from NRS scale data generated throughout the study. NRS scale 0-10, 0=no pain, 10=worst possible pain.
Time frame: Time 0 to end of study (day 7)
Time-specific pain intensity difference for pain at rest at all time points
Recorded in patient diary. Calculated from NRS scale data generated throughout the study.NRS scale 0-10, 0=no pain, 10=worst possible pain.
Time frame: Time 0 to end of study (day 7)
Time-specific pain intensity difference for spontaneous pain on movement at all time points
Recorded in patient diary. Calculated from NRS scale data generated throughout the study. NRS scale 0-10, 0=no pain, 10=worst possible pain.
Time frame: Time 0 to end of study (day 7)
Time-specific pain intensity difference for pain at rest at all time points
Recorded in patient diary. Calculated from NRS scale data generated throughout the study. NRS scale 0-10, 0=no pain, 10=worst possible pain.
Time frame: Time 0 to end of study (day 7)
Time to complete pain relief (Score = 0 pain)
NRS scale 0-10, 0=no pain, 10=worst possible pain.
Time frame: Time 0 to end of study (day 7)
Time to complete resolution of pain-on-movement (Score = 0 pain)
NRS scale 0-10, 0=no pain, 10=worst possible pain.
Time frame: Time 0 to end of study (day 7)
Time to complete resolution of pain at rest (Score = 0 of pain)
NRS scale 0-10, 0=no pain, 10=worst possible pain.
Time frame: Time 0 to end of study (day 7)
Time to the first request of rescue medication within the first 24 hours
If applicable
Time frame: Time 0 to 24 hours
Proportion of patients taking rescue medication per dosing interval and during the entire evaluation period
If applicable
Time frame: Time 0 to end of study (day 7)
Responder rate (defined as the number of patients achieving 50% reduction from baseline in the NRS score for pain-on-movement at 24 hours)
NRS scale 0-10, 0=no pain, 10=worst possible pain.
Time frame: Time 0 to 24 hours
Global efficacy assessment by investigator (5 point scale) at Visit 2, Visit 3, Visit 4, and Visit 6
5-point Likert scale. 0 = excellent, 4 = very poor
Time frame: At Visit 2 (~24 hours), 3 (~48 hours), 4 (~72 hours), and 6 (~168 hours)
Global efficacy assessments by patient (5 point scale) at Visit 2, Visit 3, Visit 4, and Visit 6
5-point Likert scale. 0 = excellent, 4 = very poor
Time frame: At Visit 2 (~24 hours), 3 (~48 hours), 4 (~72 hours), and 6 (~168 hours)
Overall dose of rescue medication
Rescue medication use will be assessed at every visit except Visit 1
Time frame: Time 0 to end of study (Day 7)
Local tolerability at every visit except V1
Examination for presence of erythema (0-3, 0 = none; 3 = severe), edema (0-3, 0 = none; 3 = severe), papiculation/vesiculation (0-3, 0 = none; 3 = severe), pruritus (NRS scale 0-10; 0 = no itch, 10 = worst possible itch), burning (NRS scale 0-10; 0 = no itch, 10 = worst possible itch)
Time frame: Time 0 to end of study (day 7)
Blood pressure exam at V1 and V6
Systolic/diastolic blood pressure
Time frame: At Visit 1 (time 0) and 6 (168 hours)
Adverse events at every visit
Time frame: Time 0 to end of study (day 7)
Examination of pulse at V1 and V6
Pulse measured as beats per minute
Time frame: At Visit 1 (time 0) and 6 (168 hours)
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Jun 2027, 8 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Aponia Laboratories, Inc.