Fever due to viral infection MedDRA version: 20.1 Level: PT Classification code 10051998 Term: Febrile infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Kidofen Duo
Product Name: Kidofen Duo
Pharmaceutical Form: Oral suspension
Trade Name: Kidofen
Product Name: Kidofen
Pharmaceutical Form: Oral suspension
Trade Name: Paracetamol Aflofarm
Sponsors
Aflofarm Farmacja Polska Sp. z o.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Children age over 24 months to the end of 72 months 2) Fever defined as tympanic body temperature = 38,3°C 3) Viral infection based on clinical assessment 4) C-reactive protein rapid test showing viral infection (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Hypersensitivity to ibuprofen, paracetamol, other NSAiDs or other constituents of tested products 2) History of hypersensitivity reactions (bronchospasm, angioedema, asthma, rhinitis, urticaria) following aspirin ingestion or other NSAiDs, history of aspirin-induced asthma in parents 3) Current or past ulceration, perforation or bleeding from gastrointestinal tract 4) Severe renal insufficiency 5) Severe hepatic insufficiency 6) Any coagulation disorders 7) Hereditary disorders of carbohydrate metabolism (fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency) 8) Naproxen or any other NSAiDs except ibuprofen use < 7 days before inclusion 9) Concomitant use of any physical methods or supplements affecting body temperature 10) Concomitant antimicrobials 11) Contraindications to oral route of medicine administration 12) Viral hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy assessment of combined therapy with Kidofen Duo (paracetamol plus ibuprofen) compared to monotherapy with Paracetamol Aflofarm and/or Kidofen (ibuprofen) based on average body temperature reduction;Secondary Objective: 1. Assessment of average normothermia (<37,2°C) reached in combined therapy group (paracetamol plus ibuprofen) compared to monotherapy groups with ibuprofen and/or paracetamol 2. Assessment of average change in body temperature during treatment in combined therapy group (paracetamol plus ibuprofen) compared to monotherapy groups with ibuprofen and/or paracetamol ;Primary end point(s): Average body temperature differences in combined therapy group with Kidofen Duo (paracetamol+ibuprofen) compared to monotherapy groups with Paracetamol Aflofarm (paracetamol) and/or Kidofen (ibuprofen);Timepoint(s) of evaluation of this end point: 30 min, 1 h, 1,5 h, 2 h, 3 h, and 4 h, 5 h, 6 h and/or before next dose of Paracetamol Aflofarm, 30 min, 1 h, 1,5 h, 2 h, 3 h ,4 h, 5 h, and 6 h, 7 h, 8 h and/or before next dose of Kidofen and Kidofen Duo | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 30 min, 1 h, 1,5 h, 2 h, 3 h, and 4 h, 5 h, 6 h and/or before next dose of Paracetamol Aflofarm, 30 min, 1 h, 1,5 h, 2 h, 3 h ,4 h, 5 h, and 6 h, 7 h, 8 h and/or before next dose of Kidofen and Kidofen Duo;Secondary end point(s): 1. Average normothermia (<37,2°C) reached in combined therapy group (paracetamol plus ibuprofen) compared to monotherapy groups with ibuprofen and/or paracetamol 2. Average change in body temperature during treatment in combined therapy group (paracetamol plus ibuprofen) compared to monotherapy groups with ibuprofen and/or paracetamol | — |
Countries
Poland
Contacts
Public ContactClinical Trial Information
Aflofarm Farmacja Polska Sp. z o.o.
Outcome results
None listed