| 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 |
| evaluate the: 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 |
| 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 (See Appendix 1); 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 |
| 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. Patients with osteoarthritis will be included as long as it is mild or moderate (according to investigator’s criteria) and it does not affect 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 (See Appendix 3); Acetylsalicylic acid (ASA) at doses of >325 mg/day. Patients taking </=325 mg ASA for non-analgesic or non-arthritic reasons, at a stable dose before Screening/Baseline, will be allowed to continue their ASA regimen for the duration of the study. The ASA must be taken at least 1 hour before the morning dose of study medication; Oral or injectable (including intra-articular) corticosteroids administered within 2 weeks of Screening/Baseline. Patients are allowed to continue intranasal or orally-inhaled corticosteroids provided they have been at a stable dose for at least 30 days prior to Screening/Baseline and the dose is not expected to change during the duration of the study; Intra-articular injections of hyaluronic acid in the Index Joint. Hyaluronic acid injections are allowed in joints other than the Index Joint if used for osteoarthritis; Anticoagulants (such as warfarin, heparin, low molecular weight heparin); Colchicine >1.2 mg daily. Patients taking a stable daily dose </=1.2 mg daily for 30 days prior to Screening/Baseline will be allowed; Allopurinol, Patients taking stable doses of allopurinol for at least 2 weeks prior to Screening/Baseline will be allowed; Lithium; 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; |
|
| 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) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| 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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
| 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 | 1 |
| E.8.9.1 | In the Member State concerned months | 7 |
| 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 | 8 |
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