Osteoarthritis of the knee or hip that requires taking NSAIDs for at least 14 days and hypertension stabilized with drugs. MedDRA version: 15.0 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 15.0 Level: LLT Classification code 10029875 Term: OA hip System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: SPIDIFEN*OS GRAT 30BUST 600MG
Pharmaceutical Form: Granules
CAS Number: 15687-27-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Trade Name: BRU
Sponsors
ZAMBON S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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] =65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to compare IBA vs. IBU in the change from baseline of daily spontaneous pain in patients suffering from OA and stabilized hypertension.;Secondary Objective: no;Primary end point(s): Change versus baseline of daily spontaneous pain, assessed by Visual-Analogical Scale (VAS), in both treatment arms, reported by Patients on daily diaries from Day 0 to Day 14.;Timepoint(s) of evaluation of this end point: from Day 0 to Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Change versus baseline (Day 0) in Office sitting SBP and DBP at Day 7 and 15 measured and recorded with Microlife Watch BP Office Target by the Investigator in the office visit; •Change versus baseline in Seven Day Average SBP and DBP measured by Home BP Monitoring (HBPM) calculated after 7 (interval day 1 to 7) and after 14 days (interval day 8 to 14) , with Microlife Watch BP 03 (Home mode); •Change versus baseline in 24-hour average SBP and DBP measured by ABPM (at Day -1 to 0 and at Day 14 to 15) by Microlife Watch BP 03 (Ambulatory mode); •Change versus baseline (Day -1 to 0) in day-time pulse pressure (SBP-DBP) measured at Day 14 to 15 with Microlife Watch BP 03 (Ambulatory mode); •Change versus baseline in ADMA test (Asimmetric DiMetilArginine) measured at Day 0 and Day 15, after 14 days treatment; •Change versus baseline (Day 0) in daily morning stiffness by VAS values, assessed daily at morning, at wake up time, by patient from Day 0 to Day 14 - after 14 days of treatment; •Change versus baseline of Fatigue based on FSS questionnaire at Day 0 and Day 15, - after 14 days of treatment, administered by Investigator.;Timepoint(s) of evaluation of this end point: See what reported above. | — |
Countries
Italy
Contacts
Public ContactSponsor Contact Point
Zambon S.p.A.
Outcome results
None listed