Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07225634 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study of Combogesic® IV (Intravenous) in Pediatric Patients With Acute Pain

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 6 more changesShow less
    • Trial sites expanded: 1 → 4 locations
    • Start date changed from estimate of Sep 2026 to Sep 14, 2026
    • Interventions: Combogesic® IV (fixed-dose combination containing acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion) (Drug) to Combogesic® IV (fixed-dose combination containing acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion) (Drug)
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 1 of 31 entries
    • Collaborators expanded, about 1 word
  2. Start date: Feb 2026 to Sep 2026
    • Primary completion date: Oct 2026 to Mar 2027
    • Study completion date: Oct 2026 to Apr 2027
    • Eligibility criteria shortened, about 84 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07225634
Lead Sponsor AFT Pharmaceuticals, Ltd.
Collaborators: HungaroTrial
Conditions
(from sponsor)		 Acute Pain
Related terms Acute Pain
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov