Acute PainPhase 3NCT07225634
A Study of Combogesic® IV (Intravenous) in Pediatric Patients With Acute Pain
A Phase 3 study testing Combogesic® IV (fixed-dose combination containing acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion) in people with Acute Pain, run by AFT Pharmaceuticals, Ltd. at 4 sites in Hungary.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Combogesic® IV (fixed-dose combination containing acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesHungary
- Study dates
- 14 Sep 2026to Apr 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Is male or female aged between 2 and <17 years.
- Have a clinical indication of acute pain* requiring hospitalization and multiple doses of parenterally administered nonopioid analgesic medication for at least 0.5 - 5 days.
- Is either able to provide written informed consent or consent is provided from parents/legal guardians and assent provided from participants (where appropriate).
- Is willing and able to remain at the study site for at least 12 hours and to attend a follow-up visit at 7 ± 2 days after the last dose of study drug.
- Have negative HIV and hepatitis B \& C test results.
- Acute pain indications may include but are not limited to post-operative pain associated with musculoskeletal or soft tissue surgery, fractures or injury, or medical procedures.
Who cannot join
- Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, opioids, or any nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen); history of NSAID-induced bronchospasm (subjects with the triad of asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and should be considered carefully); or hypersensitivity, allergy, or significant reaction to sulfa (including sulfonamide) medicines, ingredients of the study drug, or any other drugs used in the study including anesthetics and antibiotics that may be required.
- Has experienced any surgical complications or other issues that, in the opinion of the Investigator, could compromise the safety of the subject if he or she participates in the study or could confound the results of the study.
- Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease or any other condition that, in the opinion of the Investigator, could compromise the subject's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation.
- Has a history or current diagnosis of a significant psychiatric disorder that, in the opinion of the Investigator, would affect the subject's ability to comply with the study requirements.
- Has a history of a clinically significant (Investigator opinion) gastrointestinal (GI) event within 6 months before screening or has any history of peptic or gastric ulcers or GI bleeding.
- Has a surgical or medical condition of the GI or renal system that might significantly alter the absorption, distribution, or excretion of any drug substance.
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- Is considered by the Investigator, for any reason to be an unsuitable candidate to receive the study drug.
- Is receiving systemic chemotherapy, has an active malignancy of any type, or has been diagnosed with cancer within 5 years before Screening (excluding treated squamous or basal cell carcinoma of the skin).
- Is currently receiving anticoagulants (e.g. heparin or warfarin).
- Has received a course of systemic corticosteroids (either oral or parenteral) within 3 months before screening (inhaled nasal steroids and regional/limited area application of topical corticosteroids (Investigator discretion) are allowed).
- Has a history of chronic use (defined as daily use for > 2 weeks) of NSAIDs, opiates, or glucocorticoids (except inhaled nasal steroids and regional/limited topical corticosteroids), for any condition within 6 months before study drug administration. Aspirin at a daily dose of ≤ 325 mg is allowed for cardiovascular prophylaxis if the subject has been on a stable dose regimen for ≥ 30 days before screening and has not experienced any relevant medical problem.
- Has a significant renal or hepatic disease, as indicated by clinical laboratory assessment (results ≥ 3 times the upper limit of normal [ULN] for any liver function test, including aspartate aminotransferase [AST], alanine aminotransferase [ALT], or creatinine ≥ 1.5 times the ULN).
- Has any clinically significant laboratory finding at screening that, in the opinion of the Investigator, contraindicates study participation.
- Participated in another clinical study within 30 days before Screening.
- Pregnant or lactating females
- Sexually active females of childbearing potential not using adequate contraception and sexually active males not using adequate contraception
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary4 sites, 4 recruiting
- Recruiting
Semmelweis University
Budapest
Zoltan Jenovari, +3612151380, jenovari.zoltan@semmelweis.hu
Zoltan Jenovari
- Recruiting
Petz Aladar County Teaching Hospital
Győr
Csilla Bogar, 0036704510266, bogarcsilla@gmail.com
Csilla Bogar
- Recruiting
University of Pecs
Pécs
Peter Vajda, +36309161243, vajda.peter@pte.hu
Peter Vajda
- Recruiting
Zala County St. Rafael Hospital
Zalaegerszeg
Pap Zsolt, +36703309139, pap.zsolt@gmail.com
Pap Zsolt
About this study
Official title: An Open Label, Pharmacokinetic and Safety Study of Combogesic® IV 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 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?
Read more
- 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.
- Conditions
- Acute Pain
- Being tested
- Combogesic® IV (fixed-dose combination containing acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion)
- Keywords
- pharmacokinetic, pediatric, Combogesic IV, safety
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combogesic® IV (fixed-dose combination containing acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Combogesic® IV | Experimental | 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 Receives: Drug: Combogesic® IV (fixed-dose combination containing acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of exposure to Combogesic® IV up to 7 days after last dose
Secondary outcomes (31)
The time course of treatment-emergent adverse events
Measured: From start of exposure to Combogesic® IV up to 7 days after last dose
The incidence of treatment-related adverse events
Measured: 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)
Measured: From start of exposure to Combogesic® IV up to 7 days after last dose
Changes in heart rate
Measured: 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.
Measured: 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?
- = Poor;
- = Fair;
- = Good;
- = Very Good;
- = Excellent
The patient's global evaluation of the study drug will be summarized by the number and percentage of subjects within each category.
Measured: 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
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Pre-dose of Combogesic® IV to 6 hours post infusion
Changes in blood pressure
Measured: From baseline up to 7 days after last dose of Combogesic® IV
Changes in body temperature
Measured: From baseline up to 7 days after last dose of Combogesic® IV
Changes in respiratory rate
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline up to 7 days after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2025
- Study start14 Sep 2026
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AFT Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HungaroTrial
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225634
- Sponsor's protocol ID
- AFT-MXIV-08p
- Status last verified
- Sep 2026
- First submitted
- 30 Oct 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Pharmacokinetic and Safety Study of Combogesic® IV in Pediatric Patients With Acute Pain
- ClinicalTrials.gov ID
- NCT07225634
- Acronym / sponsor ID
- AFT-MXIV-08p
- Conditions
- Acute Pain
- Keywords
- pharmacokinetic, pediatric, Combogesic IV, safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AFT Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- HungaroTrial
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 6 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combogesic® IV | Experimental | Drug: Combogesic® IV (fixed-dose combination containing acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion)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 |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Is male or female aged between 2 and <17 years.
- Have a clinical indication of acute pain* requiring hospitalization and multiple doses of parenterally administered nonopioid analgesic medication for at least 0.5 - 5 days.
- Is either able to provide written informed consent or consent is provided from parents/legal guardians and assent provided from participants (where appropriate).
- Is willing and able to remain at the study site for at least 12 hours and to attend a follow-up visit at 7 ± 2 days after the last dose of study drug.
- Have negative HIV and hepatitis B \& C test results.
Key exclusion criteria (16 listed)
- Has a known history of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, opioids, or any nonsteroidal anti-inflammatory drugs (NSAIDs, including ibuprofen); history of NSAID-induced bronchospasm (subjects with the triad of asthma, nasal polyps, and chronic rhinitis are at greater risk for bronchospasm and should be considered carefully); or hypersensitivity, allergy, or significant reaction to sulfa (including sulfonamide) medicines, ingredients of the study drug, or any other drugs used in the study including anesthetics and antibiotics that may be required.
- Has experienced any surgical complications or other issues that, in the opinion of the Investigator, could compromise the safety of the subject if he or she participates in the study or could confound the results of the study.
- Has any clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease or any other condition that, in the opinion of the Investigator, could compromise the subject's welfare, ability to communicate with the study staff, or otherwise contraindicate study participation.
- Has a history or current diagnosis of a significant psychiatric disorder that, in the opinion of the Investigator, would affect the subject's ability to comply with the study requirements.
- Has a history of a clinically significant (Investigator opinion) gastrointestinal (GI) event within 6 months before screening or has any history of peptic or gastric ulcers or GI bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Combogesic® IV |
Primary outcome
The incidence of treatment-emergent adverse events (TEAEs) associated with exposure to Combogesic® IV in pediatric patients
Time frame: From start of exposure to Combogesic® IV up to 7 days after last dose
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.
31 secondary outcomes
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)
Time frame: From baseline up to 7 days after last dose
Patient's global evaluation of the study drug
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)
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)
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)
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)
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)
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)
Time frame: From baseline up to 7 days after last dose
Changes in hematology values (Hematocrit)
Time frame: From baseline up to 7 days after last dose
Changes in hematology values (Platelet count)
Time frame: From baseline up to 7 days after last dose
Changes in hematology values (Red Blood Cell (RBC) count)
Time frame: From baseline up to 7 days after last dose
Changes in hematology values (White Blood Cell (WBC) count)
Time frame: From baseline up to 7 days after last dose
Changes in hematology values (Differential Leukocyte Count (DLC))
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Sodium)
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Potassium)
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Urea)
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Creatinine)
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Phosphate)
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Glucose)
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Albumin)
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Total protein)
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Alkaline phosphates)
Time frame: From baseline up to 7 days after last dose
Changes in biochemistry values (Gamma-glutamyl transferase)
Time frame: From baseline up to 7 days after last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Combogesic® IV (fixed-dose combination containing acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion) in people with Acute Pain, run by AFT Pharmaceuticals, Ltd. at 4 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Boddington (+64 9 488 0232 ext 735, laura.boddington@aftpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of treatment-emergent adverse events (TEAEs) associated with exposure to Combogesic® IV in pediatric patients (time frame: From start of exposure to Combogesic® IV up to 7 days after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.