osteoarthritis Classification code 10031161
Conditions
Interventions
Trade Name: Prexige
Product Name: Prexige
Product Code: COX189
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Lumiracoxib
CAS Number: 220991-20-8
Concentration unit: mg milligram(s)
Conc
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ambulatory cooperative male or female patients of at least 18 years of age. 2. With an acute attack of gout in 4 joints or less, diagnosed clinically according to the ACR 1977 classification criteria and with an onset within the last 48 hours prior to evaluation. Where more than one joint is involved, the most affected joint should be identified, as the study joint, at baseline and followed throughout the study. 3. Who present at Baseline with an acute pain intensity of at least moderate. The baseline pain intensity assessment should be taken: a. 4 hours after the last dose of =400 mg ibuprofen, = 1 g paracetamol, = 600 mg aspirin or = 2 tablets of other over-the-counter analgesic aspirin-based or paracetamol-based combination medications, or b. 8 hours after the last dose of > 400 mg ibuprofen, = 50 mg diclofenac, or c. 12 hours after the last dose of > 500 mg naproxen. 4. Femals are eligible only if they are neither pregnant (ß-hCG serum pregnancy test negative) nor lactating, and are either: surgically sterilized (tubular ligation or hysterectomy), postmenopausal for at least 24 months past last natural menses, postmenopausal with last natural menses in the past 24 months, and with an FSH > 40 IU/L and serum estradiol =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. With an acute attack of gout before the last 48 hours prior to evaluation. 2. With polyarticular gout involving =4 joints. 3. With rheumatoid arthritis, infectious arthritis, pseudo-gout or other acute inflammatory arthritides. 4. Who have taken non-steroidal anti-inflammatory drugs in the previous 24 hours (other than ibuprofen, paracetamol, aspirin, diclofenac, naproxen as described above). 5. Who have taken etoricoxib in the previous 48 hours. 6. Taking systemic use or intra-articular injection (in the previous 4 weeks) of steroids. 7. With clinically significant hepatic disease or renal disease. 8. With impared renal functions taking ACE-inhibitors. 9. With inflammatory bowel disease. 10. With previous or active peptic ulceration or clinically significant gastrointestinal bleeding. 11. Who have experienced asthma, acute rhinitis, nasal polyps, angioneurotic edema, urticaria or other allergic-type reactions after taking aspirin, paracetamol/acetaminophen, any NSAIDs and/or COX-2 inhibitors. 12. With known hypersensitivity to lumiracoxib, indomethacin and/or paracetamol/acetaminophen. 13. Who have received treatment with an investigational drug within the past month or 10 half-lives, whichever is longer. 14. Who are taking: a. Lithium, b. Warfarin, any coumarin related therapy, or similar anticoagulants, c. Phenytoin. 15. Who are involved in health-related litigation. 16. With a history of: a. attacks of gout known to be unresponsive to NSAIDs, b. malignancys of any organ system, treated or untreated, within the past five years whether or not evidence of local recurrence or metastases exists are excluded (with the exception of localized basal cell carcinoma of the skin), c. coronary heard disease with ECG-evidence of silent myocardial ischemia, d. congestive heart failure with symptoms at rest or with minimal activity (NYHA class III-IV), e. unstable angina, f. variant angina (Prinzmetal`s angina) g. drug or alcohol abuse. 17. Allopurinol or colchicine treatment is allowed if the dose has been stable for =2 weeks prior to baseline for allopurinol or = 4 weeks prior to baseline for colchicine and remains unchanged throughout the 7 days of the study. 18. With significant medical problems, including but not limited to the following: uncontrolled hypertension, heart failure, type I diabetes (well controlled type II diabetes is allowed even when required insulin), thyroid disease (unless the patient is on controlled thyroid hormone for at least 3 month), active hepatic disease, known HIV seropositivity, epilepsy, parkinsonism, psychiatric disturbance. 19. With history of cardiac and cerebral thrombotic/ischemic diseases and/or events are excluted from the study: a. Angina pectoris (of any severity) or other evidence of coronary heart disease, b. Myocardial infarction, c. Coronary artery bypass grafting (CABG) or precutaneous coronary intervention (any PCI procedutre), d. Transient ischemic attack, e. Clinically significant carotid artery stenosis or hoistory of carotid endarterectomy, f. Ischemic stroke, g. Congestive heart failure, NYHA class III-IV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate that lumiracoxib 400 mg od is not inferior to indomethacin 50 mg tid in the treatment of acute gout with respect to the mean change from baseline over days 2 to 5 of pain intensity assessed in the study joint approximately 4 hours after the first daily dose of study medication on each day.;Secondary Objective: 1. To assess the safety and tolerability profile of lumiracoxib in comparison to indomethacin. 2. To explore the efficacy of lumiracoxib 400 mg od as compared to indomethacin 50 mg tid with respect to the mean change from baseline of pain intensity in the study joint over the entire treatment period 2-7 days. 3. To assess the efficacy of lumiracoxib as compared to indomethacin by visit with respect to: Patient`s global assessment of response to therapy. Physician`s global assesment of response to therapy. Physician`s assessment of tenderness of study joint. Physician`s assessment of swelling of study joint. C-reactive protein level. Proportion of patients who discontinued treatment because of a lack of efficacy. Usage of rescue medication. 4. SF-36 and EQ-5D 5. To perform exploratory analysis of physician`s assessment of erythema of study joint.;Primary end point(s): The primary end point is the measurement of patient`s pain intensity assessed in the study joint approximately 4 hours after the first daily dose of study medication on each day. | — |
Countries
Germany
Outcome results
None listed