Evaluation of efficacy and safety of Ibuprofen Arginine 600 mg tid vs. Ibuprofen 600 mg tid in the treatment of pain and inflammation in Osteoarthritis (OA) patients with hypertension pharmacologically stabilized.

ZAMBON S.p.A.0 个研究点开始时间: 2012年9月12日最近更新: 2013年12月23日

试验速览

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•1)Male or female patients aged = 50 and = 80 years; 2)Patients suffering from knee or hip OA symptoms exacerbation requiring intake of NSAIDs for at least 14 days; 3)Hypertensive stabilized patients (sitting office systolic blood pressure [SBP] <160 mmHg and sitting office diastolic blood pressure [DBP] <100 mmHg) since six months under pharmacological treatment in monotherapy or with no more than three antihypertensive drugs association among the following: AT1 antagonists or ACE inhibitors or Calcium-channel-blockers or diuretics (except the monotherapy with Calcium-channel-blockers or diuretics and their association); 4)Patients having moderate to severe pain (pain intensity = 50 on a 0-100 VAS) at the randomization visit; 5)Signed informed consent; 6)Willing and able to comply with study procedures.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 130

•1)Ascertained or presumptive hypersensitivity to the active compound and/or any of the formulation excipients; 2)History of anaphylaxis to drugs or allergic reactions; in particular, history of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria, angioedema) to non-steroidal anti-inflammatory drugs (NSAIDs); 3)Obstructive respiratory syndromes (asthma or COPD), nasal polyposis or any other chronic respiratory disease; 4)History of psychosis (e.g. schizophrenia or psychotic depression) or major depression (requiring treatment); 5)Severe neurological diseases, including dementia, anxiety, mental retardation, multiple sclerosis, Parkinson’s disease, uncontrolled epilepsy; 6)Transient ischemic attack or cerebrovascular accident within the last three months before the screening visit; 7)Myocardial infarction, unstable angina, arrhythmias, cardiac failure (NYHA class II-IV) or other chronic cardiac diseases; 8)Significant kidney (Creatinine Clearance <80 ml/minute) or liver disease (serum transaminases = 3 x upper limit of normal); 9)History of gastrointestinal diseases, active peptic ulcer, gastrointestinal intolerance or gastrointestinal bleeding in the preceding 6 months before the screening visit.

发起方

ZAMBON S.p.A.