None listed
Conditions
Interventions
MK-0663 90 mg, once a day for 6 weeks.
Group name:Placebo Type of group
Placebo once a day for 6 weeks
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Inclusion criteria
Inclusion criteria: • The patient is 12 years of age or older and weighs at least 40 kg. • The female patient must demonstrate a level of p-HCG subunit in serum consistent with a non-pregnancy status in Visit 1.0, and agree to abstain from abstinence, or to use a double-barrier method of contraception (the couple use condom and patient diaphragm, contraceptive sponge, spermicide or IUD), from at least 7 days before Visit 2.0, and continue for at least 14 days after Visit 5.0 or the discontinuation visit. Women who are in the postmenopausal period or who have undergone hysterectomy or tubal ligation are exempt from complying with this requirement (Postmcnopausic is defined as being without limitation during the last previous year.) If the end of menstruation is within the 12 months prior to the study, the level of FSH raised to the postmenopausal range should be documented in the pre-study). • The patient has a diagnosis of hemophilia (deficiency of factor HIV or IX, with or without inhibitor), a history of intra-articular hemorrhage, and chronic symptomatic arthropathy (odor in one or more joints during 20 of the 30 days prior to entering the study) ). • The patient´s main source of pain should be the hip, knee, ankle, or elbow (the most painful joint will be selected in order to evaluate it for admission and clinical response). • The patient was diagnosed with hemofortic arthropathy at least 6 months before the start of the study. • The patient has a history of positive therapeutic benefit (pain relief) with analgesic agents. • The patient took analgesic medication regularly and at a therapeutic dose level at least 30 days before entering the study (on a regular basis is defined as at least 20 of the previous 30 days, therapeutic dose level it is defined in Appendix I in terms of the number of tablets per month). • The patient must demonstrate a minimum level of arthropathic pain prior to randomization. Patients using acetaminophen must demonstrate a minimum of 40 mm (Visual Analogical Scale of 100 mm for arthropathic pain), both in the selection (Visit 1.0), and in the Baseline (Visit 2.0). Patients using a non-acetylated salicylate or a COX-2 inhibitor should demonstrate a worsening of the pain of hemophilic arthropathy defined as> 40 mm (100 mm Visual Analogue Scale for arthropathic pain), and an increase of 15 mm after discontinuing the previous therapy in the Selection Visit (Visit 1.0). • The patient is willing to avoid excess alcohol during the study (more than 2 drinks per day), and unaccustomed physical activity (for example, lifting weights, initiation of physiotherapy) during the 6 weeks of the study. • Except for hemophilic arthropathy, the patient is considered to be in good general health according to his medical history, physical examination and routine laboratory analysis (see Appendices 4 and 5). • The patient is able to understand and complete the study questionnaires, including questions that require a response to a visual analogue scale (VAS). • The patient understands the study procedures and agrees to participate in it by giving written informed consent.
Exclusion criteria
Exclusion criteria: to. The patient is legally or mentally incapacitated, has emotional problems of importance at the time of the study, or with a history of psychosis or dementia. b. The patient presents a concurrent arthropathic / clinical pathology, which could confuse or interfere with the assessment of efficacy, which includes, but is not limited to: rheumatoid arthritis, systemic lupus, polymyalgia rheumatica, gout, pseudogout, psoriatic arthritis , Reiter syndrome, Paget´s disease, and ochronosis. c. The patient has a history of gastric, biliary or small bowel surgery that causes clinical malabsorption. d. The creatinine clearance of the patient is estimated at <30 ml / min or the serum creatinine level is higher than 2.0 mg / dL [Men: (140-age) x weight (kg) / (serum creatinine (mg / dl ) x 72); Women: (0.85) (140-age) x weight (kg) / (serum creatinine (mg / dl) x72)]. and. The patient presents angina pectoris or congestive heart deficiency, with symptoms that occur when resting or performing minimal activity, and / or has a history of myocardial infarction, cerebrovascular accident, transient ischemic attack, last year. F. The patient is hypertensive uncontrolled. [Note: Clinically controlled hypertensive patients can participate (diastolic blood pressure <95 mm Hg, systolic blood pressure <165 mm Hg).]. g. The patient shows any evidence of liver failure as assessed by the Child-Pugh scale criteria h. The patient has a history of neoplastic pathologies and does not meet any of the following exceptions. Patients with a history of leukemia, lymphoma or myeloproliferative pathologies are not eligible for this study, regardless of the time elapsed since treatment. In such cases, no exception shall apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The primary efficacy analysis will be based on the average change from the baseline, referred to time, in the patients assessment of pain, on a Visual Analogue Scale. Measure:Efficacy Timepoints:After 2, 4, and 6 weeks of therapy. | — |
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed