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NCT07225140 · ClinicalTrials.gov registry record · Phase 3
A Study of Combogesic® 325 in Adolescent Patients With Moderate to Severe Postoperative Pain Associated With Orthopedic Surgery
A Phase 3 study, sponsored by AFT Pharmaceuticals.
- Not yet
- Registry status
- Phase 3
- Development phase
- 180
- Enrollment target
NCT07225140: Clinical Trial Phase 3 study, sponsored by AFT Pharmaceuticals.
NCT07225140 is a Phase 3 study that has not yet begun recruiting, run by AFT Pharmaceuticals. The registered enrollment target is 180 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07225140, a Phase 3 study, has not yet begun recruiting, sponsored by AFT Pharmaceuticals.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 180 participants
- Enrollment target
Study Summary
Combogesic® 325 contains a combination of ibuprofen and acetaminophen. The purpose of this study is to compare the pain relief effects of Combogesic® 325mg and acetaminophen and to evaluate the safety of Combogesic® 325mg in adolescents between the ages of 12 and \<18 years. What will the study involve for participants? * Participants will be randomly allocated to one of 3 treatment groups: * 3 tablets of Combogesic® 325, * 2 tablets of Combogesic® 325 and 1 tablet of placebo or * 2 tablets of acetaminophen1000mg and 1 tablet of placebo * Participants will take 3 tablets every 6 hours with a maximum of 4 doses in 24 hours * Participants and study doctor will be blinded to the treatment group * If pain is not sufficiently controlled, opioids may be used as supplementary pain relief at the discretion of the study doctor. * Participants will complete a patient diary to assess their pain * Participants will rate the study drug at the end of the treatment. It is expected that Combogesic® tablets (either 2 or 3 tablets per dose) will provide a greater reduction in pain compared to acetaminophen (1000 mg) treatment.
Primary Outcome
SPID will be derived from the 100 mm Visual Analogue Scale which is the tool used for patients to rate the intensity of their pain on a horizontal 100mm line with 0 on one end and 100 on the other end (0 being no pain and 100 being the worst pain unimaginable). The primary analysis will compare three tablets of Combogesic® against acetaminophen
Interventions
- DRUG Placebo
- DRUG Acetaminophen 500mg
- DRUG Combogesic® tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2026-10 |
| Est. Completion | 2027-10 |
| Phase | Phase 3 |
What is known before NCT07225140 opens enrollment
NCT07225140 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT07225140 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07225140 about?
NCT07225140 is a clinical study titled "A Study of Combogesic® 325 in Adolescent Patients With Moderate to Severe Postoperative Pain Associated With Orthopedic Surgery". Combogesic® 325 contains a combination of ibuprofen and acetaminophen. The purpose of this study is to compare the pain relief effects of Combogesic® 325mg and acetaminophen and to evaluate the safety of Combogesic® 325mg in adolescents between the ages of 12 and \<18 years. What will the study inv...
What is the current status of trial NCT07225140?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2026-10. Estimated completion is 2027-10.
What interventions are being tested in trial NCT07225140?
The interventions under investigation include: Placebo (DRUG), Acetaminophen 500mg (DRUG), Combogesic® tablets (DRUG).
Who is sponsoring clinical trial NCT07225140?
This trial is sponsored by AFT Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07225140's enrollment target sits among peer trials
180 1422nd of 2000 higher than 564 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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