Relief of signs and symptoms of acute gouty arthritis. MedDRA version: 9.1 Level: LLT Classification code 10018634 Term: Gouty arthritis
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: CELECOXIB
CAS Number: 169590-42-5
Concentration unit: mg milligram(s)
Concentrat
Sponsors
Pfizer Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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). 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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% (App
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.; Secondary Objective: 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. ;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. | — |
Countries
Italy, Spain, United Kingdom
Outcome results
None listed