Study comparing ibuprofen and ibuprofen arginine in the control of spontaneous pain in patients with osteoarthritis and stabilized hypertension.

Conditions: Osteoarthritis of the knee or hip that requires taking NSAIDs for at least 14 days and hypertension stabilized with drugs.
MedDRA version: 15.0Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 15.0Level: LLTClassification code 10029875Term: OA hipSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2011-003826-28-IT

Lead Sponsor: ZAMBON S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.