Efficacy and Tolerability of Dexibuprofen Film coated tablets in Comparison to Ibuprofen in Children and Adolescents with Tonsillopharyngitis - n.a.

Gebro Pharma GmbH0 sites200 target enrollmentStarted: June 9, 2005Last updated: March 19, 2012

Drugs

Trial Snapshot

No summary available.

•male or female patients between 8 and 18 years of age, diagnosed tonsillopharyngitis (TPS score > 4), acute sore throat pain (moderate, severe or extreme), written informed consent/assent (parents and children/adolescents);
•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

•patients previously sensitive to dexibuprofen or ibuprofen, to any other NSAID, or to any excipient of the products; 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 active or suspected gastrointestinal ulcer or history of gastrointestinal ulcer (in the past 6 months); patients who have gastrointestinal 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; pregnancy; connective tissue diseases such as e.g. lupus erythematosus and other autoimmune diseases; use of analgesic, antipyretic or anti-inflammatory drugs within the last 3 days prior to entry into the trial, regular use of concomitant treatment of drugs with pharmacological effects that may modify the results of the trial (e.g. antibiotics) or use of cold medication within the past 4 hours, participation in an other clinical trial less than 30 days ago, simultaneous participation in an other clinical trial;

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