| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Classification code | 10031161 |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| 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. |
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| E.2.2 | Secondary objectives of the trial |
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. |
|
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal 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 (β-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. |
|
| E.4 | Principal 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.
|
|
| E.5 End points |
| E.5.1 | 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. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
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