pharmakodynamik: Acute post-operative pain after an operation (surgery) (acute is defined as within 4 hours after end of surgery). pharmakokinetik: Acute post-operative pain is not necessary. Trial medication will be used after surgery as defined in Amendment III (Trial Protocol). MedDRA version: 8.1 Level: LLT Classification code 10054711
Conditions
Interventions
Product Name: Dexibuprofen [S(+)-ibuprofen]
Product Code: n.a.
Pharmaceutical Form: Oral suspension
INN or Proposed INN: S(+)-ibuprofen, Dexibuprofen
CAS Number: 0051146-56-6
Current Sponsor code: n.
Sponsors
Gebro Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Pharmakokinetik/ Pharmakodynamik: male or female patients; age between 2 and 11 years (children) and 18 and 55 years (adults), body weight between 12 kg and 121 kg (> 11 kg and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: post-opertive i.v. analgesics during the intubation and after the extubation period when oral ingestion is not possible, post-operative emesis which makes an oral ingestion of the IMPDs four hours after surgery impossible, patients hypersensitive to dexibuprofen or ibuprofen, to any other NSAID, or to any excipient of the products; pregnancy; participation in an other clinical trial less than 30 days ago, simultaneous participation in an other clinical trial; patients already treated under this protocol, patients taken in custody by court or authorities, patients in whom substances with similar action (e.g. aspirin or other NSAIDs) precipitate attacks of asthma, bronchospasm, acute rhinitis, or causal nasal polyps, urticaria or anioneurotic oedema; patients with anemia, patients with active or suspected gastrointestinal ulcer or history of gastrointestinal ulcer (in the past 6 months); patients who have gastro-intestinal bleeding or other active bleedings or bleeding disorders; patients with Crohn´s disease or ulcerative colitis, with severe heart failure, with severe renal dysfunction (GFR < 30 ml/min), with severely impaired hepatic function, with haemorrhagic diathesis and other coagulation disorders, or patients receiving anticoagulant therapy; connective tissue diseases such as e.g. lupus erythematosus and other autoimmune diseases;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective is to test bioequivalence between adults and children according to CPMP/EWP/QWP/401/98 guideline. Pharmacokinetic information may be used to extrapolate clinical efficacy and safety from adult to paediatric patients as well as between paediatric patients of different ages. Provided that data from adults are considered relevant, pharmacokinetic information can be used to extrapolate efficacy and safety to the paediatric population. Similar exposure (plasma concentration) in adult and paediatric patients is assumed to result in similar efficacy, therefore pharmacokinetic data alone can be used to extrapolate efficacy and safety. In particular, the serum levels of dexibuprofen can be readily related to the pharmacological or therapeutic effects. The present clinical trial was designed to investigate pharmacokinetic/pharmacodynamic profile of dexibuprofen ready oral suspension in adults and in children (population bioequivalence). ;Secondary Objective: Second aim is to compare efficacy and tolerability of dexibuprofen ready oral suspension with ibuprofen liquid formulation, which is already exhaustive used in children. Secondary objective is to test non-inferiority of the investigational medicial product (dexibuprofen) versus an active control (ibuprofen) concerning pain relieve according to CPMP/ICH/363/96 guideline. According to international requirements about efficacy equivalence trials with an active control (accepted reference drug) the trial is designed as an one-sided equivalence or non-inferiority trial (Garbe E et al 1995) (Schmidt K 1995). Starting from the assumption that dexibuprofen and ibuprofen are equally effective, a one-sided test is used to prove in a confirmatory way that the efficacy of the test preparation (dexibuprofen) in patients with acute post-operative pain is at least equal to or even superior to the reference preparation (ibuprofen). ;Primary end point(s): Pharmacokinetic part: Primary efficacy criteria: | — |
Countries
Austria
Outcome results
None listed