EUCTR2019-000647-27-IT
Active, not recruiting
Phase 1
Evaluation of efficacy and bioavailability of a new pediatric formulation based on ibuprofen lysinate vs ibuprofen in the management of pain in children - Efficacy and bioavailability of ibuprofen lysinate
Dicofarm S.p.A.0 sites84 target enrollmentOctober 7, 2020
ConditionsPain on an inflammatory basis (otitis and otomastoiditis, adenite, cellulite, arthritis) and post-operative painMedDRA version: 21.0Level: PTClassification code 10050533Term: Pain assessmentSystem Organ Class: 10022891 - InvestigationsMedDRA version: 20.1Level: LLTClassification code 10063374Term: Pain scaleSystem Organ Class: 10022891 - InvestigationsTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Pain on an inflammatory basis (otitis and otomastoiditis, adenite, cellulite, arthritis) and post-operative pain
- Sponsor
- Dicofarm S.p.A.
- Enrollment
- 84
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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)
Outcomes
Primary Outcomes
Not specified
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