Double Blind, Parallel, Controlled, Compared Group Study of 4 Weeks in Length, Performed Under Internal Blind Conditions, to Evaluate the Efficacy of rofecoxib versus Celecoxib in Patients Suffering from Osteoarthritis of the Knee or Hip and Show an Inadequate Clinical Response to celecoxib
- Conditions
- -M131M131
- Registration Number
- PER-023-00
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• The patient is male or female, is at least 40 years old and has a clinical diagnosis of osteoarthritis (OA) of the knee (tibiofemoral joint) or hip for a period of more than 6 months according to the clinical and radiological criteria specified in the Appendix 1. Patients who have recently been diagnosed with this disease should present clinical symptoms consistent with osteoarthritis of the joint under study during the last 6 months. In addition, they must meet the criteria indicated in Appendix 1.
• The knee or hip should be the main source of pain / disability of the patient in the lower limb (if both knees and / or hips are affected, the most painful joint will be selected in order to evaluate it to determine its inclusion and clinical response) .
• Patients must demonstrate a level of serum P-hCG consistent with a non-pregnant status at the pre-study visit and must agree to remain abstinent, use oral contraceptive pills or use the method of mechanical barrier contraception (the couple will use condoms) or the patient´s diaphragms, contraceptive sponges or an intrauterine device) starting at least 7 days before treatment and for at least 14 days after Visit 5 or the discontinuation visit. Post-menopausal women or those who have undergone hysterectomy or tubal ligation are exempt from this requirement (post-menopausal women are those who have not menstruated during the previous year.) If menses stopped occurring within a year, FSH it must be documented as elevated in the postmenopausal range before the start of the study).
• Functional Class I, II or III of the American Rheumatology Association (American Rheumatology Association)
• The patient is willing to limit alcohol consumption to 14 servings per week and avoid strenuous physical activity to which they are not accustomed (for example: lifting unaccustomed weight and initiating physical therapy) for the duration of the study and the follow-up period.
• With the exception of osteoarthritis, the patient is otherwise considered to be in good general health by taking into account his medical history, physical examination and routine laboratory tests (Appendices 4 and 5).
• The patient is able to understand and complete study questionnaires that include questions that require a visual analogue scale (VAS) response.
• The patient understands the study procedures and agrees to participate in the study by giving written informed consent.
• The evaluation of pain that the patient experiences at night when lying down (Question 3 of Section A. of WOMAC) in the screening visit (Visit 1) and in the randomization visit (Visit 2) must be greater or equal at 40 mm (VAS of 100 mm).
• The evaluation of pain experienced by the patient while walking on a flat surface (Question 1 of Section A. of WOMAC) at the screening visit (Visit 1) and at the randomization visit (Visit 2) should be equal or less of 80 mm (VAS of 100 mm).
• The patient should report a history of positive therapeutic benefit in osteoarthritis of the knee or hip with previous use of NSAIDs in the past. In addition, the patient must have been taking celecoxib regularly during the treatment of osteoarthritis at a dose of 200 mg daily for at least 14 days before enrollment in the study (regularly is defined as greater than or equal to 14 the previous 15 days).
• In the screening visit (Visit 1) and in the randomization visit (Visit 2), the Global Assessment of the Condition of the Dise
Previous Arthritis History
to. The patient has a concurrent medical / inflammatory joint disease that could confuse or interfere with the evaluation of efficacy including, without limitation:
Inflammatory arthritis (for example: rheumatoid arthritis, systemic lupus, spondyloarthropathy, psoriatic arthropathy, Reiter syndrome [reactive arthritis], ankylosing spondylitis, arthritis associated with inflammatory bowel disease, polymyalgia rheumatica), gout, episodes of acute monoarticular arthritis that agree, from the clinical point of view, with the pseudo-gout, Paget´s disease affecting the joint under study, a history of septic arthritis or intra-articular fracture of the joint under study, dissecting osteochondritis or osteonecrosis of the joint under study, Wilson´s disease, hemochromatosis, ochronosis or primary osteochondromatosis. Patients with isolated patellofemoral disease that manifests mainly with pain in the anterior region of the knee and the absence of tibiofemoral radiological findings will be excluded from this study.
b. The patient has a history of acute injury to the ligaments or meniscus of the joint under study within the previous 2-year period or arthroscopy of the affected knee within the period of 6 months before entry into the study.
Other Concurrent / Prior Medical Conditions
c. In the opinion of the investigator, the patient is mentally or legally incapacitated, which prevents obtaining informed consent, or can not read or understand written material.
d. The patient has a history of a significant clinical or laboratory adverse event that, in the opinion of the researcher, contraindicates the application of a 4-week therapy with NSAIDs.
and. The estimated creatinine clearance of the patient [Men: (140-age) x weight (kg) / (serum creatinine (mg / dL) x 72); Women: (0.85) (140-age) weight (kg) / serum creatinine (mg / dL) x 72] is <30 mL / min or serum creatinine is greater than 2.0.
F. The patient suffers from angina pectoris or congestive heart failure, with symptoms that occur while at rest or in minimal activity.
g. The patient suffers from uncontrolled hypertension. [Note: patients with hypertension who are under medical control can participate (diastolic blood pressure <95, systolic blood pressure <165)].
h. The patient has a history of gastric, biliary or small bowel surgery with associated malabsorption.
i. The patient suffers from uncontrolled diabetes mellitus, kidney disease, stroke or neurological disorder, cardiovascular, hepatic or neoplastic disease (patients with cancer of the skin or carcinoma of the cervix may participate and receive the appropriate treatment; history of neoplastic disease duly treated without evidence of recurrence for a minimum period of one year), or any other disease that, in the investigator´s judgment, could confuse the results of the study or represent an additional risk to the patient.
j. The patient suffers from depression (treated or untreated), or has suffered from depression in the last 12 months; the patient is affected by some other disease that could alter his interpretation of the pain and his reaction to it.
k. The patient has some personal or family history of a hereditary coagulation disorder.
l. The patient is currently consuming (including recreational use) any illicit drug or has a history of drug or alcohol abuse in the last 5 years.
m. The patient is allergic or manifests hypersensitivity (for
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The WOMAC V 3 Questionnaire will be administered in its entirety.<br>Measure:Efficacy<br>Timepoints:Visits 1, 2, 3, 4 y 5<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:• None - it is not good, it is inefficient<br>• Poor-has some effect, but is unsatisfactory<br>• Regular-has a reasonable effect, but could be better<br>• Good-has a satisfactory effect with occasional episodes of pain and / or rigidity<br>• Excellent-has an ideal response, virtually pain-free<br>Measure:Response to Therapy<br>Timepoints:Visits 3, 4 y 5<br>;<br>Outcome name:Adverse experiences will be monitored during the entire study, which will be recorded, in each of the exams, in the Adverse Event Case Report Forms.<br>Measure:Safety<br>Timepoints:During the whole study<br>