| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Relief of signs and symptoms of acute gouty arthritis. |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10018634 |
| E.1.2 | Term | Gouty arthritis |
|
| 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 the superior analgesic efficacy of the celecoxib 800/400 mg regimen compared to the celecoxib 50 mg BID, in the treatment of patients with moderate to extreme pain due to acute gouty arthritis. |
|
| E.2.2 | Secondary objectives of the trial |
Secondary objectives of this study are to evaluate the:
• anti-inflammatory effects of celecoxib (celecoxib 800/400 mg and 400/200 mg regimens compared to celecoxib 50 mg BID) in the treatment of patients with moderate to extreme pain due to acute gouty arthritis;
• analgesic efficacy of celecoxib 400/200 mg regimen compared to celecoxib 50 mg
BID in the treatment of patients with moderate to extreme pain due to acute gouty
arthritis
• analgesic efficacy and anti-inflammatory effects of 3 celecoxib dosage regimens
compared to indomethacin in patients with moderate to extreme pain due to an acute gouty arthritis;
• safety and tolerability of celecoxib in patients with moderate to extreme pain due to acute gouty arthritis. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Male and female patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
1. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
2. At least 18 years of age or older;
3. Acute gouty arthritis meeting the American College of Rheumatology (ACR) criteria
for acute arthritis of primary gout;
4. Onset of pain from an acute gouty arthritis attack within 48 hours prior to
Screening/Baseline (Visit 1);
5. A rating of moderate, severe, or extreme (2, 3, or 4, respectively) on the Patient’s
Assessment of Pain Intensity in the Index Joint (5-point scale: 0-4) at Screening/Baseline;
6. Candidate for daily therapy with an NSAID and/or analgesic, in the investigator’s
judgment;
7. Patients who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures;
8. If the patient is female and of childbearing potential, she must be using adequate
contraception since her last menses, continue using adequate contraception during the study, not lactating, and must have had a negative urine pregnancy test confirmed at Screening/Baseline. (Note: Women who are post-menopausal or are surgically sterilized for less than 2 years, will also require a urine pregnancy test at
Screening/Baseline). |
|
| E.4 | Principal exclusion criteria |
Patients presenting with any of the following are excluded from participation in the study:
1. Diagnosis of any other type of arthritis including those types suspected of being infectious in origin or presence of any acute trauma in the Index Joint
2. Acute polyarticular gout (involving greater than 4 joints) or chronic gout
3. Use of any NSAID or analgesic therapy to treat the current acute gouty arthritis attack
4. Patients on any of the following medications are specifically excluded:
Chronic NSAID and/or analgesic therapy (defined as >1 week) within 5 half lives (for the particular agent) prior to Screening/Baseline
Acetylsalicylic acid (ASA) at doses of >325 mg/day
Oral or injectable (including intra-articular) corticosteroids administered within 2 weeks of Screening/Baseline
Intra-articular injections of hyaluronic acid in the Index Joint
Lithium and anticoagulants (such as warfarin, heparin, low molecular weight heparin)
Local anesthetics, including regional blocks within 48 hours prior to Screening/Baseline and for the duration of the study
Any other investigational medication within 30 days prior to Screening/Baseline or patient is scheduled to receive an investigational drug during the course of this study
5. History of acute or chronic gouty arthritis that has been unresponsive to NSAIDs
6. Any significant, uncontrolled disease, or condition which, in the opinion of the investigator, would contraindicate study participation or confound interpretation of the results
7. Known laboratory abnormality; including AST, ALT, or blood urea nitrogen (BUN) >1.5 × the upper limit of the reference range, creatinine >1.5 mg/dL, or any other laboratory abnormality that in the opinion of the investigator would contraindicate study participation [Results from the analyses of complete blood count (CBC), blood chemistries, and/or urinalysis obtained within 6 months prior to Screening/Baseline must be available for determination of eligibility]
8. History of known alcohol or other substance abuse (in the investigator’s opinion) within 2 years of Screening/Baseline
9. Diagnosed as having or has been treated for esophageal, gastric, pyloric channel, or duodenal ulceration within 60 days prior to Screening/Baseline
10. Known hypersensitivity allergy or hypersensitivity to sulfonamides, COX-2 selective inhibitors (including celecoxib), aspirin or NSAIDS (including indomethacin)
11. Active GI disease (eg, inflammatory bowel disease, Crohn’s disease, ulcerative colitis, gastroesophageal reflux disease), a chronic or acute renal or hepatic disorder, a significant coagulation defect, or any condition that in the investigator’s opinion might preclude the use of an NSAID
12. Active malignancy of any type, including suspected metastases, or treatment for cancer (ie, surgery, chemotherapy, radiation therapy, etc.), or remission from any cancer other than basal cell carcinoma for less than 2 years prior to Screening/Baseline
13. Patient has symptoms, signs or treatment for congestive heart failure (NYHA Classification II-IV) or known left ventricular dysfunction with ejection fraction <40% (Appendix 4)
14.The patient has history of myocardial infarction, cerebrovascular accident (stroke), and coronary artery bypass
15. Any planned revascularization (PCI) within 6 months
16. The patient has an unstable condition defined as any of the following at Screening/Baseline:
Clinically significant ECG abnormalities as determined by the investigator
Unstable angina within the previous 6 months
Blood pressure measurement of systolic BP >160 mmHg and/or diastolic BP
>95 mmHg at screening
Hospitalization or emergency department visits for cardiac-related illness in the previous 6 months
Has undergone any major surgery (cardiac or non-cardiac) or trauma within the previous 6 months prior to Screening/Baseline
17. Patients who are known, or suspected to be CYP2C9 poor metabolizers based on previous history or experience with other CYP2C9 substrates
18. Likelihood to be non-compliant with study procedures
19. Participated previously in this study
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary endpoint of the study will be the Change from Baseline to Day 2 (24-hour recall of pain experienced during Day 2 assessed on the morning of Day 3) in the Patient’s Assessment of Pain Intensity in the index joint. |
|
| 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 | No |
| 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 | Yes |
| E.6.10 | Pharmacogenetic | No |
| 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) | Information not present in EudraCT |
| 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) | Information not present in EudraCT |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Information not present in EudraCT |
| E.8.1.3 | Single blind | Information not present in EudraCT |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Information not present in EudraCT |
| E.8.1.6 | Cross over | Information not present in EudraCT |
| E.8.1.7 | Other | Information not present in EudraCT |
| 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
| Information not present in EudraCT |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 100 |
| 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 |
|
| E.8.7 | Trial has a data monitoring committee | Yes |
| 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
| |
| 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 | |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 10 |
| E.8.9.2 | In all countries concerned by the trial days | 16 |
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