Evaluation of efficacy and bioavailability of ibuprofen lysinate

Phase 1

• Conditions: Pain on an inflammatory basis (otitis and otomastoiditis, adenite, cellulite, arthritis) and post-operative pain; MedDRA version: 21.0Level: PTClassification code 10050533Term: Pain assessmentSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.1Level: LLTClassification code 10063374Term: Pain scaleSystem Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2019-000647-27-IT
• Lead Sponsor: Dicofarm S.p.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-07
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Age between 4-12 years
• Post-operative pain and pain on an inflammatory basis: mild (FPS-R: 2) or mild-moderate (FPS-R: from 4 to 6)
• Understanding of the Italian language by parents or legal guardian
• Written informed consent, signed by the parents or legal guardian
• Consent of the child with age between 8-12 years
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Hypersensitivity to ibuprofen, to any other NSAID or to any of the excipients of the product: Purified water, Microcrystalline cellulose, Sodium carboxymethyl cellulose, Sorbitol (E-420), Maltitol (E-965), Beta-cyclodextrin, Sodium saccharin,
Sucralose (E-955), Aroma of wild berries, Allura Red AC dye (E-129), Methyl para-hydroxybenzoate (E-218), Ethyl para-hydroxybenzoate (E-214), Propyl para-hydroxybenzoate (E-216)
• Verified allergy to ibuprofen or or acetylsalicylic acid or other NSAIDs (attacks of asthma, acute rhinitis, urticaria or angioneurotic oedema)
• Gastrointestinal haemorrhage or perforation related to previous treatments with NSAIDs
• Peptic ulcer, active or recurrent gastrointestinal haemorrhage (two or more separate episodes)
• Crohn's disease or active ulcerative colitis
• Severe heart failure (NYHA class IV)
• Renal failure (GFR <35mL / min, calculated with Schwartz formula, according to pRIFLE-Pediatric Risk, Injury, Failure, Loss, End Stage Renal Disease)
• Acute liver failure (Pediatric Acute Liver Failure Registry, PALF):
- Acute onset liver failure (8 weeks from the onset of liver disease)
- Biochemical evidence of liver damage (elevation of ALT, AST and / or total and conjugated bilirubin)
- Incorrect coagulopathy from vitamin K (INR> = 1.5)
- Clinical evidence of encephalopathy
• Chronic hepatic failure (starting with Pugh-Child Score Class A)
• Haemorrhagic diathesis or coagulation disorders
• Pregnancy
• Cognitive delay
• Lack of understanding of the Italian language by parents or legal guardian

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Compare the analgesic efficacy of ibuprofen lysinate compared to ibuprofen, by filling in the pain pain scale Faces pain scale e Faces pain scale – revised (FPS-R).;Secondary Objective: Compare the bioavailability and the pharmacokinetic profile of ibuprofen lysinate compared to ibuprofen, through the evaluation of the main pharmacokinetic parameters (AUC, Tmax, Cmax);Primary end point(s): The analgesic efficacy of the two formulations will be studied by verifying the reduction in pain reported by the child, through the compilation of the pain detection scale Faces pain scale - revised (FPS-R).;Timepoint(s) of evaluation of this end point: The filling of the pain detection scale will be at the following timepoints:<br>- T0 (enrollment)<br>- T1 (5 minutes from drug administration)<br>- T2 (10 minutes from drug administration)<br>- T3 (20 minutes from drug administration)<br>- T4 (48 ± 6 hours after administration) of the drug)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The bioavailability and the pharmacokinetic profile of the 2 formulations are evaluated by measuring:<br>- Area under the curve from time 0 to 20 minutes post-dose (AUC0-480min) estimated with the trapezoid method<br>- Systemic clearance of the two formulations (ratio between the dose of drug administered and the AUC)<br>- Cmax and Tmax (measured directly in the daily pharmacokinetic profile);Timepoint(s) of evaluation of this end point: Pharmacokinetic evaluations will be performed 2 days after starting therapy with one of the two ibuprofen formulations. Specifically, blood samples will be collected:<br>- at time 0 (immediately before the administration of the fourth dose)<br>- 5 minutes after administration of the fourth dose<br>- 10 minutes after administration of the fourth dose<br>- 20 minutes after administration of the fourth dose