Population pharmacokinetic/pharmacodynamic and tolerability clinical trial in patients suffering from acute post-operative pain - Dexibuprofen ready oral suspensio
- Conditions
- 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: 8.1Level: LLTClassification code 10054711
- Registration Number
- EUCTR2005-006069-15-AT
- Lead Sponsor
- Gebro Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 192
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 < 122 kg), written informed consent/assent (parents and children, adults); operation (surgery).
pharmakodynamik only: acute post-operative pain (at least moderate).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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
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;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method