Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-26 @ 12:49 AM
Study NCT ID:
NCT07225634
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-06
First Post:
2025-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Combogesic® IV (Intravenous) in Pediatric Patients With Acute Pain
Sponsor:
AFT Pharmaceuticals, Ltd.
Organization:
Study Overview
Official Title:
An Open Label, Pharmacokinetic and Safety Study of Combogesic® IV in Pediatric Patients With Acute Pain
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: