A 1-week, multi-center, randomized, double-blind, double-dummy, active-controlled, parallel trial of lumiracoxib (400 mg od) in patients with acute flares of gout, using indomethacin (50 mg tid) as a comparator
- Conditions
- osteoarthritisClassification code 10031161
- Registration Number
- EUCTR2005-000229-51-DE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
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 < 18 pg/ml, or
with an FSH = 40 IU/L and serum estradiol =18 pg/ml, and using an acceptable form of bith control,
premenopausal and using an acceptable form of birth control.
Acceptable forms of birth control must be used for greater than 2 month prior to the screening visit (visit 1) and include an IUD, a barrier method with spermicide, condoms, subdermal implants or oral contraceptives. Femals of childbearing piotential must continue to practice an acceptable form of birth control during the trial and for at least 2 month after completing the trial. Single agent estrogen is not an acceptable form of birth control. FSH and estradiol tests do not need to be performed on premenopausal, surgically sterile, or women on estrogen replacement therapy.
5. Who signed an information consent before entering the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method