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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From start of exposure to Combogesic® IV up to 7 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| The time course of treatment-emergent adverse events | From start of exposure to Combogesic® IV up to 7 days after last dose | |
| The incidence of treatment-related adverse events | From start of exposure to Combogesic® IV up to 7 days after last dose |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura Boddington | Contact | +64 9 488 0232 ext 735 | laura.boddington@aftpharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours Children's Health | Orlando | Florida | 32827 | United States |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D012996 | Solutions |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| The incidence of treatment-emergent adverse events of interest (cardiovascular, gastrointestinal, renal, hepatic, administration site conditions and bleeding-related events) | From start of exposure to Combogesic® IV up to 7 days after last dose |
| Changes in heart rate | 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. | 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?
The patient's global evaluation of the study drug will be summarized by the number and percentage of subjects within each category. | 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 | 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). | 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 | 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 | 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 | 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 | Pre-dose of Combogesic® IV to 6 hours post infusion |
| Changes in blood pressure | From baseline up to 7 days after last dose of Combogesic® IV |
| Changes in body temperature | From baseline up to 7 days after last dose of Combogesic® IV |
| Changes in respiratory rate | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From baseline up to 7 days after last dose |
| D004364 |
| Pharmaceutical Preparations |