None listed
Conditions
Interventions
Group 1 Type of group
Placebo orally for 6 weeks
Group name:Group 4 Type of group
Loxoprofen 60 mg t.i.d orally for 6 weeks
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient, male or female, is at least 40 years old and has a clinical diagnosis of osteoarthritis of the knee (tibiofemoral joint) for more than 6 months based on clinical and radiographic criteria specified in Appendix 3. Recently diagnosed patients should have clinical symptoms consistent with osteoarthritis of the study joint during the previous 6 months. They must also meet the criteria specified in Appendix 3. Since the primary objective of this study is to support the registration of MK-0966 in Japan, every effort will be made to enter mainly Japanese patients. • The knee should be the main source of pain / disability in the patient´s lower limb (if both knees are affected, the joint that produces the most pain will be selected to evaluate inclusion and clinical response) • Women must demonstrate a level of serum p-HCG that matches an ungrafted state in the pre-study visit and must agree to abstain, use birth control pills, or use double-barrier contraception (the couple will use condoms and the patient diaphragms, contraceptive sponges or IUD) starting at least 7 days before treatment and at least 14 days after Visit 5.0 or the discontinuation visit. Postmenopausal women or those who have undergone hysterectomy or tubal ligation are exempt from this requirement (Postmenopausal refers to a woman who has not menstruated during the previous year.) If menstruations stopped occurring within a period of less than 1 year , FSH should be elevated in the pre-study in postmenopausal range). • Functional class 1,11 or III of ARA • In general, the patient wants to limit alcohol consumption to no more than 14 drinks per week and avoid strenuous physical activity not used (for example, unaccustomed weight lifting, initiation of physical therapy) during the study and period of follow up. • Except for osteoarthritis, the patient is considered to be in good health based on his medical history, physical examination and routine laboratory tests. • The patient is able to understand and answer the questionnaires of the study including the questions that require a response in the visual analogue scale (VAS). • The patient understands the study procedures and agrees to participate in the study by providing written informed consent. • The patient must have a history of positive therapeutic benefit with NSAIDs in the treatment of osteoarthritis of the knee. Likewise, patients must take an NSAID regularly and at a therapeutic dose level for at least 30 days before entering the study (on a regular basis means more than 20 days out of the previous 30 days) . • The evaluation of pain when walking on a flat surface (WOMAC Section A, Question 1) in the pre-study visit is less than 80 mm (VAS of 100 mm). • Prior to randomization and after discontinuation of the NSAID during the washout period specified in Appendix I, patients must meet all criteria for joint crisis in Visit 2.0 (joint crisis visit)
Exclusion criteria
Exclusion criteria: • The patient suffers from a simultaneous medical / arthritic disease that could confuse or interfere with the assessment of efficacy including, without limitation: inflammatory arthritis (eg, rheumatoid arthritis, systemic lupus, spondyloarthropathy, polymyalgia rheumatica), gout, arthritis episodes acute monoarticular syndrome clinically consistent with pseudogout, Paget´s disease affecting the study joint, history of septic arthritis or intra-articular joint fracture of the study joint, osteochondritis dissecans or osteonecrosis of the study joint, Wilson´s disease, hemacromatosis, ochronosis, or osteochondromatosis primary. • History of acute damage to the meniscus or ligaments of the study joint within the previous 2 years or arthroscopy of the affected knee within 6 months prior to entry into the study. • In the opinion of the investigator, the patient is mentally or legally incapacitated to provide informed consent or to read and understand the written material. • The patient has a history of gastric, biliary or small bowel surgery that causes clinical malabsorption. • The patient has a history of a clinical or laboratory adverse event that in the opinion of the investigator contraindicates a 6-week therapy with an NSAID such as loxoprofen (for example, the patient has concurrent active peptic ulcers, serious hematological, hepatic or renal conditions) , serious heart failure and asthma induced by NSAIDs). • The patient suffers from angina pectoris or congestive heart failure, with symptoms that occur at rest or minimal activity. • The patient suffers from uncontrolled hypertension • The patient has a history of stroke or transient ischemic attack (within the last 2 years) or active / unstable liver disease. • The patient has a history of neoplastic disease. Patients who have a history of leukemia, lymphoma or myeloprolitis can not participate in the study regardless of the time elapsed since treatment. Exceptions: (a) patients with adequately treated basal cell carcinoma or carcinoma in situ of the cervix may participate; and (b) patients with other tumors that have been successfully treated> 10 years before the selection can participate, where in the opinion of the investigator and the attending physician, adequate follow-up has not revealed any evidence of recurrence from the treatment until now of the selection. • The patient has a history of a disease that, in the opinion of the investigator, could confuse the results of the study or pose an additional risk to the patient. • The patient is a user (including the recreational use) of an illicit drug, or has a history of alcohol or drug abuse in the last 5 years. • The patient is allergic to acetaminophen or has hypersensitivity (eg, bronchoconstriction in association with nasal polyps) to aspirin, rofecoxib, celecoxib, loxoprofen, ibuprofen, indomethacin, and other NSAIDs. [Note: Patients with a history of a potential idiosyncratic allergic reaction (eg rash) to a single NSAID (except for loxoprofen and / or rofecoxib) may participate, but tolerate at least 2 other NSAIDs without suffering hypersensitivity reactions.] • The patient suffers from morbid obesity and demonstrates significant health problems due to his obesity. • Patients will not be able to participate in the study if the following medications have been used; Corticosteroids have been given intravenously, intramuscularly, or orally within the month before en
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Global Evaluation of the Response to Therapy by the Patient and of the Global Assessment of the State of the Disease by the Investigator during the 6 weeks of therapy. Measure:Average change in the values of the joint pain visit when walking on a flat surface Timepoints:6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Scale of pain WOMAC VA Measure:Pain WOMAC VA Timepoints:6 weeks ; Outcome name:Global Assessment of the Condition of Disease by the Patient Measure:Global Assessment of the Condition of Disease by the Patient Timepoints:6 weeks ; Outcome name:Global Evaluation of the Response to Therapy by the Investigator Measure:Global Evaluation of the Response to Therapy by the Investigator Timepoints:6 weeks ; Outcome name:Percentage of discontinuations due to lack of efficacy Measure:Percentage of discontinuations due to lack of efficacy Timepoints:6 weeks | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed