Tonsillopharyngitis
Conditions
Interventions
Trade Name: Movone
Product Name: Movone (Dexibuprofen)
Product Code: n.a.
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: S(+)-ibuprofen, Dexibuprofen
CAS Number: 0051146-56-6
Current Spo
Sponsors
Gebro Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the analgesic efficacy in the first 6 hours of a single oral dose of 100 mg Dexibuprofen with 200 mg Ibuprofen in children and 200 mg Dexibuprofen versus 400 mg Ibuprofen in adolescents with sore throat pain due to tonsillopharyngitis. ;Secondary Objective: To compare the overall effectiveness of dexibuprofen with ibuprofen during a 3 days treatment period in patients suffering from sore throat complaints due to tonsillopharyngitis. To evaluate and compare the tolerability profile of dexibuprofen and ibuprofen in children and adolescents.;Primary end point(s): complete pain relief measured as pain intensity differences and relief of pain within the firts 4 hours after taking the first trial medication: ensemble of primary criteria SPID0-4 and TOTPAR0-4 | — |
Countries
Germany
Outcome results
None listed