A Phase 3 interventional study of Combogesic® IV (fixed-dose combination containing acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion) in Acute Pain, sponsored by AFT Pharmaceuticals, Ltd.. Recruiting at 4 sites in Hungary. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by AFT Pharmaceuticals, Ltd. · Phase 3, Interventional, and Treatment
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?
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.
1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.
This study's planned enrollment of 60 is below the median of 86 across 902 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →AFT Pharmaceuticals, Ltd. is the lead sponsor of 9 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Have negative and \& C test results.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Combogesic® IV (acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion), will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes every 6 hours
Drug: Combogesic® IV (fixed-dose combination containing acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion)
Acetaminophen 1000 mg and Ibuprofen 300 mg per 100 mL solution for intravenous infusion administered as a 15-minute infusion, every 6 hours, as necessary.
The incidence of treatment-emergent adverse events (TEAEs) associated with exposure to Combogesic® IV in pediatric patients
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.
Time frame: From start of exposure to Combogesic® IV up to 7 days after last dose
The time course of treatment-emergent adverse events
Time frame: From start of exposure to Combogesic® IV up to 7 days after last dose
The incidence of treatment-related adverse events
Time frame: From start of exposure to Combogesic® IV up to 7 days after last dose
The incidence of treatment-emergent adverse events of interest (cardiovascular, gastrointestinal, renal, hepatic, administration site conditions and bleeding-related events)
Time frame: From start of exposure to Combogesic® IV up to 7 days after last dose
Changes in heart rate
Time frame: From baseline up to 7 days after last dose of Combogesic® IV
Changes in biochemistry values (Aspartate transaminase)
The number of cases with normal baseline laboratory tests changed to abnormal at the end of the treatment period, and abnormal baseline laboratory tests worsened at the end of the treatment period, with the severity of changes summarized as proportional effects will be evaluated.
Time frame: From baseline up to 7 days after last dose
Patient's global evaluation of the study drug
Each patient will rate the study medication using a questionnaire of: How do you rate the study medication? 1. = Poor; 2. = Fair; 3. = Good; 4. = Very Good; 5. = Excellent The patient's global evaluation of the study drug will be summarized by the number and percentage of subjects within each category.
Time frame: From Day 1 until completion of treatment period up to 5 days.
Define the pharmacokinetic parameters of Combogesic® IV (Cmax - Maximum measured plasma concentration)
This will be estimated for paracetamol and ibuprofen from the plasma concentration against time data, using a non-compartmental model
Time frame: Pre-dose of Combogesic® IV to 6 hours post infusion
Consumption of supplemental opioid medication in each 24-hour period as Morphine Milligram Equivalent (MME).
Time frame: From start of exposure to Combogesic® IV until up to 5 days
Define the pharmacokinetic parameters of Combogesic® IV (Tmax - Time of maximum measured plasma concentration)
This will be estimated for paracetamol and ibuprofen from the plasma concentration against time data, using a non-compartmental model
Time frame: Pre-dose of Combogesic® IV to 6 hours post infusion
Define the pharmacokinetic parameters of Combogesic® IV ( t½ - Time required for the plasma drug concentration to decrease by one half)
This will be estimated for paracetamol and ibuprofen from the plasma concentration against time data, using a non-compartmental model
Time frame: Pre-dose of Combogesic® IV to 6 hours post infusion
Define the pharmacokinetic parameters of Combogesic® IV (AUC(0-t) - The area under the plasma concentration versus time curve from time zero to the last measurable concentration)
This will be estimated for paracetamol and ibuprofen from the plasma concentration against time data, using a non-compartmental model
Time frame: Pre-dose of Combogesic® IV to 6 hours post infusion
Define the pharmacokinetic parameters of Combogesic® IV (Extrapolated AUC(0-∞)- The area under the plasma concentration versus time curve, from zero to infinity)
This will be estimated for paracetamol and ibuprofen from the plasma concentration against time data, using a non-compartmental model
Time frame: Pre-dose of Combogesic® IV to 6 hours post infusion
Changes in blood pressure
Time frame: From baseline up to 7 days after last dose of Combogesic® IV
Changes in body temperature
Time frame: From baseline up to 7 days after last dose of Combogesic® IV
Changes in respiratory rate
Time frame: From baseline up to 7 days after last dose of Combogesic® IV
Changes in hematology values (Hemaglobin)
The number of cases with normal baseline laboratory tests changed to abnormal at the end of the treatment period, and abnormal baseline laboratory tests worsened at the end of the treatment period, with the severity of changes summarized as proportional effects will be evaluated.
Time frame: From baseline up to 7 days after last dose
Changes in hematology values (Hematocrit)
The number of cases with normal baseline laboratory tests changed to abnormal at the end of the treatment period, and abnormal baseline laboratory tests worsened at the end of the treatment period, with the severity of changes summarized as proportional effects will be evaluated.
Time frame: From baseline up to 7 days after last dose
Changes in hematology values (Platelet count)
The number of cases with normal baseline laboratory tests changed to abnormal at the end of the treatment period, and abnormal baseline laboratory tests worsened at the end of the treatment period, with the severity of changes summarized as proportional effects will be evaluated.
Time frame: From baseline up to 7 days after last dose
Changes in hematology values (Red Blood Cell (RBC) count)
The number of cases with normal baseline laboratory tests changed to abnormal at the end of the treatment period, and abnormal baseline laboratory tests worsened at the end of the treatment period, with the severity of changes summarized as proportional effects will be evaluated.
Time frame: From baseline up to 7 days after last dose
Changes in hematology values (White Blood Cell (WBC) count)
The number of cases with normal baseline laboratory tests changed to abnormal at the end of the treatment period, and abnormal baseline laboratory tests worsened at the end of the treatment
Time frame: From baseline up to 7 days after last dose
Changes in hematology values (Differential Leukocyte Count (DLC))
The number of cases with normal baseline laboratory tests changed to abnormal at the end of the treatment period, and abnormal baseline laboratory tests worsened at the end of the treatment period, with the severity of changes summarized as proportional effects will be evaluated.
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Sodium)
The number of cases with normal baseline laboratory tests changed to abnormal at the end of the treatment period, and abnormal baseline laboratory tests worsened at the end of the treatment period, with the severity of changes summarized as proportional effects will be evaluated.
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Potassium)
The number of cases with normal baseline laboratory tests changed to abnormal at the end of the treatment period, and abnormal baseline laboratory tests worsened at the end of the treatment period, with the severity of changes summarized as proportional effects will be evaluated.
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Urea)
The number of cases with normal baseline laboratory tests changed to abnormal at the end of the treatment period, and abnormal baseline laboratory tests worsened at the end of the treatment period, with the severity of changes summarized as proportional effects will be evaluated.
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Creatinine)
The number of cases with normal baseline laboratory tests changed to abnormal at the end of the treatment period, and abnormal baseline laboratory tests worsened at the end of the treatment period, with the severity of changes summarized as proportional effects will be evaluated.
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Phosphate)
The number of cases with normal baseline laboratory tests changed to abnormal at the end of the treatment period, and abnormal baseline laboratory tests worsened at the end of the treatment period, with the severity of changes summarized as proportional effects will be evaluated.
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Glucose)
The number of cases with normal baseline laboratory tests changed to abnormal at the end of the treatment period, and abnormal baseline laboratory tests worsened at the end of the treatment period, with the severity of changes summarized as proportional effects will be evaluated.
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Albumin)
The number of cases with normal baseline laboratory tests changed to abnormal at the end of the treatment period, and abnormal baseline laboratory tests worsened at the end of the treatment period, with the severity of changes summarized as proportional effects will be evaluated.
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Total protein)
The number of cases with normal baseline laboratory tests changed to abnormal at the end of the treatment period, and abnormal baseline laboratory tests worsened at the end of the treatment period, with the severity of changes summarized as proportional effects will be evaluated.
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Alkaline phosphates)
The number of cases with normal baseline laboratory tests changed to abnormal at the end of the treatment period, and abnormal baseline laboratory tests worsened at the end of the treatment period, with the severity of changes summarized as proportional effects will be evaluated.
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Gamma-glutamyl transferase)
The number of cases with normal baseline laboratory tests changed to abnormal at the end of the treatment period, and abnormal baseline laboratory tests worsened at the end of the treatment period, with the severity of changes summarized as proportional effects will be evaluated.
Time frame: From baseline up to 7 days after last dose
Plan to share: No
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Started Sep 2026 (actual). Primary completion is estimated for Mar 2027, 6 months after the start.
Of 28 industry-sponsored phase 3 interventional studies under Acute Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 15. This study's planned 6 months is below that.
Counting every sponsor, half of 53 studies reached it within 14 months; a quarter within 7 and three quarters within 25.
How these figures are worked out, and which studies are left out of them.
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AFT Pharmaceuticals, Ltd.