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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 is a Phase 3 study that has not yet begun recruiting, run by AFT Pharmaceuticals. The registered enrollment target is 180 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07225140
The ClinicalTrials.gov registry entry for NCT07225140 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AFT Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT07225140 reports 0 study locations.
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.
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