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NCT07225634 · ClinicalTrials.gov registry record · Phase 3
A Study of Combogesic® IV (Intravenous) in Pediatric Patients With Acute Pain
A Phase 3 study, sponsored by AFT Pharmaceuticals.
- Not yet
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
NCT07225634: Clinical Trial Phase 3 study, sponsored by AFT Pharmaceuticals.
NCT07225634 is a Phase 3 study that has not yet begun recruiting, run by AFT Pharmaceuticals. The registered enrollment target is 60 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07225634, a Phase 3 study, has not yet begun recruiting, sponsored by AFT Pharmaceuticals.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
Study Summary
Combogesic® IV is an intravenous medicine (given by vein) containing a combination of two pain relief (analgesic) medicines called ibuprofen and acetaminophen. The goal of this clinical trial is to study the way that the body processes and clears the intravenous infusion of Combogesic® IV and that it is safe to be used in children and adolescents between the ages of 2 and \<17 years. What will the study involve for participants? * Combogesic® IV will be administered every 6 hours as necessary with a maximum of 4 doses within a 24-hour period as an intravenous infusion for about 15 minutes. * Participants will receive Combogesic® IV for a minimum of 12 hours (2 doses) up to a maximum of 5 days (20 doses). Dosing will be dependent on body weight. * If pain is not sufficiently controlled by Combogesic® IV, opioids may be used as supplementary pain relief at the discretion of the study doctor. * Have their blood samples collected before dosing and at specific times after dosing. The amount of study drug in the blood will be measured, and safety assessments (including blood and urine samples) will be done. * Rate the study drug at the end of the treatment. It is expected that Combogesic® IV will be well tolerated in children and adolescents and that the pharmacokinetics findings will be similar as compared with adults.
Primary Outcome
TEAEs occurring at any timepoint during the treatment period will be coded to MedDRA System Organ Class Code and Preferred Term and tabulated as frequencies and percentages.
Interventions
- DRUG Combogesic® IV (fixed-dose combination containing acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2026-09 |
| Est. Completion | 2027-04 |
| Phase | Phase 3 |
What is known before NCT07225634 opens enrollment
NCT07225634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which Combogesic® IV (fixed-dose combination containing acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion) is the first listed.
NCT07225634 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07225634 about?
NCT07225634 is a clinical study titled "A Study of Combogesic® IV (Intravenous) in Pediatric Patients With Acute Pain". Combogesic® IV is an intravenous medicine (given by vein) containing a combination of two pain relief (analgesic) medicines called ibuprofen and acetaminophen. The goal of this clinical trial is to study the way that the body processes and clears the intravenous infusion of Combogesic® IV and that i...
What is the current status of trial NCT07225634?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2026-09. Estimated completion is 2027-04.
What interventions are being tested in trial NCT07225634?
The interventions under investigation include: Combogesic® IV (fixed-dose combination containing acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion) (DRUG).
Who is sponsoring clinical trial NCT07225634?
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 NCT07225634's enrollment target sits among peer trials
60 1804th of 2000 higher than 177 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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