Osteoarthritis MedDRA version: 8.0 Level: LLT Classification code 10031161
Conditions
Interventions
Trade Name: Prexige 100 mg Tabletten
Product Name: Prexige
Product Code: COX189
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Lumiracoxib
CAS Number: 220991-20-8
Current Sponsor code: C
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent before any study procedure is performed. 2. Cooperative male or female outpatients of at least 50 years of age. 3. Female patients must be either post-menopausal for one year, surgically sterile, or using effective contraceptive methods such as barrier method with spermicide or intra-uterine device. Oral contraceptives use is not allowed 4 weeks prior screening and throughout the duration of the study. Patients on hormonal replacement therapy are allowed if they have been on a stable dose for at least 6 months. 4. Primary OA of the hand, hip or knee according to ACR criteria or OA of the spine. One joint will be identified as the target joint and will be evaluated throughout the duration of the trial. 5. Is expected to need NSAID or simple analgesic therapy for OA for at least the next 6 weeks. 6. Controlled hypertension with MSSBP =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures. 2. History of asthma, acute rhinitis, nasal polyps, angioneurotic edema, urticaria or other allergic-type reactions after taking acetylsalicyclic acid or NSAIDs. 3. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. 4. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/ml). 5. History of cardiac and cerebral thrombotic/ ischemic diseases and/ or events as listed below: • angina pectoris (of any severity) or other evidence of coronary heart disease; • myocardial infarction; • coronary heart disease with ECG-evidence of silent myocardial infarction; • coronary artery bypass grafting (CABG) or percutaneous coronary intervention (any PCI procedure); • clinically significant carotid artery stenosis or history of carotid endarterectomy; • congestive heart failure, NYHA class II – IV; • second or third degree heart block in the absence of permanent pacing and all potentially life-threatening arrhythmia or symptomatic arrhythmia; • clinically significant valvular heart disease; • cerebrovascular disease; • peripheral arterial disease 6. Evidence of: • Hepatic disorder (ALT or AST >1.5x upper normal limit [ULN]); bilirubin >1.2 x ULN unless secondary to Gilbert’s disease in the opinion of the investigator) • Renal disorder (serum creatinine >1.25 x ULN) • Blood coagulation disorder (i.e. hemophilia) • Anemia (hemoglobin more than 2 g/dL [20 g/L] below the lower limit of normal). • Platelet count 200 mg/dL (>11mmol/L), clinically significant diabetic neuropathy or autonomic neuropathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to demonstrate that lumiracoxib 100 mg o.d. has an improved 24-hour BP profile compared to ibuprofen 600 mg t.i.d. with respect to the effect on Ambulatory Blood Pressure Monitoring (ABPM) after 4 weeks of treatment (defined as change from baseline in average 24-hour systolic BP) in OA patients with controlled hypertension. ;Secondary Objective: Assess the effect of lumiracoxib 100 mg o.d. on diastolic BP derived from ABPM after 4 weeks of treatment in comparison to ibuprofen 600 mg t.i.d. (defined as change from baseline in average 24-hour diastolic BP). Assess the effect of lumiracoxib 100 mg o.d. on daytime and nighttime BP (systolic and diastolic) derived from ABPM after 4 weeks of treatment in comparison to ibuprofen 600 mg t.i.d. Assess the effect of lumiracoxib 100 mg o.d. on the incidence of significant increases in ABPM (defined as an increase in 10 mmHg in systolic and/ or 5 mmHg in diastolic BP) in comparison to ibuprofen 600 mg t.i.d. Perform an exploratory analysis of the effect of lumiracoxib 100 mg o.d. on the incidence of uncontrolled hypertension (defined as an increase in ABPM from <130/80 mmHg at baseline to =130 and/ or =80 mmHg after 4 weeks of treatment) in comparison to ibuprofen 600 mg t.i.d.;Primary end point(s): The primary variable is change from baseline at week 4 (defined as the week 4 value minus the baseline value) in average 24-hour ABPM systolic BP. | — |
Countries
Finland, Germany, Sweden, United Kingdom
Outcome results
None listed