A Study of Combogesic® IV (Intravenous) in Pediatric Patients With Acute Pain
ConditionAcute Pain
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age2-16
SponsorAFT Pharmaceuticals, Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Combogesic® IV (fixed-dose combination containing acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion)
DrugAcetaminophen 1000 mg and Ibuprofen 300 mg per 100 mL solution for intravenous infusion administered as a 15-minute infusion, every 6 hours, as necessary.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Combogesic® IVExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 doseSecondary outcomes
1
The time course of treatment-emergent adverse events
Time frame
From start of exposure to Combogesic® IV up to 7 days after last dose2
The incidence of treatment-related adverse events
Time frame
From start of exposure to Combogesic® IV up to 7 days after last dose3
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 dose4
Changes in heart rate
Time frame
From baseline up to 7 days after last dose of Combogesic® IVSponsors and contacts
Click on the lead sponsor to view all of their trials.
AFT Pharmaceuticals, Ltd.
Lead sponsor
HungaroTrial
Collaborator
Source ClinicalTrials.gov