Population pharmacokinetic/pharmacodynamic and tolerability clinical trial in patients suffering from acute post-operative pain - Dexibuprofen ready oral suspension

Gebro Pharma GmbH0 个研究点目标入组 192 人开始时间: 2006年2月21日最近更新: 2012年3月19日

适应症

试验速览

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•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;

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