A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Etoricoxib 60 mg and Diclofenac Sodium 150 mg in Patient With Osteoarthritis of the Knee or Hip
- Conditions
- -M16-M179 Gonarthrosis, unspecifiedGonarthrosis, unspecifiedM16M179
- Registration Number
- PER-042-02
- 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
a. The patient is male or female, at least 40 years of age, and has a clinical and radiographic diagnosis of osteoarthritis of the knee (tibiofemoral joint) or hip.
b. The patient is diagnosed as Class I, II or III functional of 4 classifications of the American College of Rheumatology
c. The patient has a history of positive therapeutic benefit in knee or hip osteoarthritis with NSAIDs previously obtained
d. The patient regularly takes a single NSAID, at a prescription concentration, for at least 30 days before admission.
e. The assessment of the patient´s walking on a flat surface pain (WOMAC Osteoarthritis Index Version VA 3.0, Question 1) at the Screening visit is <=80 mm on the 100 mm VAS scale.
F. Prior to randomization and discontinuation of previous therapy with NSAIDs during the washout period. The patient meets the following criteria for joint crisis, in its entirety, in Visit 2 (joint crisis visit):
• Minimum 40 mm in the evaluation of pain when walking on a flat surface by the patient on the VAS 100 mm scale.
• Increase of at least 15 mm in the evaluation of pain when walking on a flat surface on the part of the patient in comparison with the results of the selection recorded in Visit 1; Y
• A worsening in the Global Assessment of the State of Illness by the Investigator of at least 1 point on a 5-point Likert scale compared to the evaluation of the selection registered in Visit 1.
g. For patients of childbearing age: the patient presents a level of human chorionic gonadotropin of urine beta type compatible with a non-pregnant state in the Selection and Basal Visits 1 and 2, and agrees to use an appropriate method of double barrier contraception or abstinence from sexual contact for at least 7 days before treatment, continuing during the treatment period or until a discontinuation visit.
h. Limit alcohol intake to no more than 7 drinks per week and avoid unusual strenuous physical activity for the duration of the study.
a. Simultaneous medical / arthritic disease that could confuse or interfere with the evaluation of efficacy.
b. The patient has chondrocalcinosis, except if incidental chondrocalcinosis, which differs from the pseudogout by 1) age> 65 years, 2) without polyarthritis, 3) without prior diagnosis of pseudogout, and 4) in the opinion of the doctor, there is no pseudogout in the patient.
c. The patient has isolated patellofemoral disease that manifests mainly through pain in the anterior knee.
d. The patient has a history of acute ligament or meniscal injury of the study joint within the previous 2 years or arthroscopy of the affected study joint within 6 months prior to entering the study.
e. The patient is a candidate for imminent joint replacement.
F. In the opinion of the researcher, the patient is mentally or legally incapacitated
g. The patient has a history of gastric or biliary surgery or small bowel surgery that causes clinical malabsorption.
h. The patient has clinical or laboratory evidence of significant renal, gastrointestinal, pulmonary, liver, endocrine, neurological (apart from migraine) or other systemic disease that the investigator says contraindicates a 6-week NSAID therapy.
i. The patient´s serum creatinine is greater than 2.0 mg / dL (2 mg / dL or greater than 176.8 micromol / L).
j. The patient has angina or congestive heart failure with symptoms that occur while at rest or when performing activity
k. The patient has uncontrolled hypertension.
1. The patient has a recent history of stroke or transient ischemic attack (within the previous 2 years).
m. The patient is currently a user (including the recreational use) of any drug not allowed, or has a history of drug or alcohol abuse within the previous 5 years.
n. The patient is allergic (asthma induced by NSAIDs, urticaria or other allergic-type reactions) to paracetamol, or hypersensitive (for example, bronchoconstriction associated with nasal polyps) to aspirin or another NSAID.
o. The patient has a history of neoplastic disease
p. The patient has a history of a disease that, in the opinion of the researcher, may confuse the results of the study or pose an additional risk to the patient
q. Intravenous, intramuscular or oral corticosteroids were administered to the patient within 30 days prior to randomization.
r. The patient was administered intra-articular steroids, Hyalgan® (sodium hyaluronate), or Synvisc® (hilane GF 20) for the study joint within 3 months of enrollment or intra-articular steroids, Hyalgan®, or Synvisc® for any other articulation within 30 days prior to randomization.
s. The patient has been taking glucosamine and / or chondroitin sulfate for <6 months before the start of the study.
t. The patient is using topical, oral medications or systemic analgesics (other than current NSAIDs) that may interfere with efficacy evaluations.
or. The patient is taking warfarin, clopidogrel bisulfate (Plavix®), rifampicin, antiepileptic drugs, muscle relaxants, or high-dose aspirin.
V. Patient dosing of the concomitant medication for a chronic disease / condition has changed within 30 days prior to Visit 1 or is expected to change during the 6 week treatment period of this study.
w. The patient presents clinically significant abnormalities in the Screening Visit 1, the clinical examination or the laboratory safety tests
X. The patient has participated in a previous stu
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:Change in the mean baseline score of the time-weighted WOMAC pain subscale over a total treatment period of 6 weeks.<br><br>Measure:Efficacy<br>Timepoints:6 weeks<br>;<br>Outcome name:Adverse experiences (any, related to the drug, serious, discontinuations and adverse gastrointestinal experiences due to AENES, adverse laboratory experiences due to liver function) and changes in week 6 in vital signs and laboratory parameters.<br>Measure:Safety<br>Timepoints:6 weeks<br>
- Secondary Outcome Measures
Name Time Method