.A.
- Conditions
- -M05M05
- Registration Number
- PER-012-98
- 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.Male or female ≥ 18 years of age
b.Patient weight is 125 Kg or less. Its important that patients near the upper weight range do not demonstrate significant health problems stemming from obesity, otherwise they would be excluded.
c.Female patient must demonstrate a serum B-HCG level consistent with a nongravid state at the prestudy visit and a negative urine B-HCG test at visit 2.0 (flare visit”) prior to randomization, and agree to remain abstinent, use doble barrier contraception (partner using condom and patient using diaphragm, contraceptive sponge, or UID) beginning at least 7 days prior to treatment and continuing at least 14 days after visit 11,0 or a discontinuation visit. Posmenopausal women, or status posthysterectomy or tubal ligation are exempt.
d.Patient must satisfy at least four of seven ARA 1987 revised criteria for the diagnosis of RA.
e.The diagnosis of RA must have been present for at least 6 months prior to study start and have been made no earlier than 16 years of age.
f.ARA functional Class I, II or III.
g.Patient global assessment of disease activity (VAS of 100 mm) at the Prestudy Visit be less than 80 mm.
h.Patient must report a history of positive therapeutic Benefit with NSAIDs in the past. In addition, patients must be taken NSAID on a regular basis and at a therapeutic dose level (see apendix 2) for at least 30 days prior to study enrollment (regular basis” is defined as grater than 25 of the previous 30 days). Patient may also use the following concurrent antirheumaticx therapy: oral or I.M. gold salts, azathioprine, hydroxycloroquine, cloroquine, d -penicillamine, or sulfasalazine provide that the dose has been stable for at least the previous 6 months. One third of patients enrolled may be taking methotrexate dose ≤20mg per week provided that the dose has been stable for 3 months, and the dose Will remain stable for the duration of part I. One third of patients enrolled may be taking low-dose corticosteroids (≤7.5 mg prednisone daily) provided that they have been taking oral corticosteroids for the previous 3 months, that the dose has been stable for the previous 1 month, and that the dose Will remain stable for the duration of Part I.
i.At Visit 2.0, patient is assessed after washout of prestudy NSAID and must satisfy both activity and flare criteria before randomization. The minimum and maximum washout duration depends upon the particular prestudy NSAID and is Listed in Appendix 2.
j.Patient is willing to avoid excess alcohol for the duration of the study and unaccustomed physical activity (e.g., weight lifting, initiation of physical therapy) during Part I of the study.
k.Excepting rheumatoid arthritis, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests (see Appendices 3 and 4).
l.Patient is able to understand and complete study questionnaires including questions requiring a visual analog scale (VAS) response.
m.Patient understands the study procedures and agrees to participate in the study by giving written informed consent.
Previous or concurrent diseases
a.Patient is a mentally o legally incapacitated, has significant emotional problems at the time of the study, or has history of psychosis.
b.Patient has a concurrent medical/arthropathic disease that could confound or interfere with evaluation of efficacy including, but not limited to: Systemic lupus, spondyloarthropathy, polymyalgia rheumatica, gout, pseudogout, psoriatic arthritis, Paget’s disease, and ochronosis.
c.Patient has a history of gastric or biliar surgery, or surgery of the small intestine, (except that patients with a history of uncomplicated appendectomy or cholecystectomy may participate in the study).
d.Patient’s estimated creatinine clearance [Men: (140-age) x weight (kg)/serum creatinine (mg/dL) x 72); Women: (0.85) (140-age) x weight (kg)/serum creatinine (mg/dL) x 72)] is≤ 30mL/min or serum creatinine is grater tan 2.0.
e.History of coronary atherosclerotic disease with active angina or a history of congestive heart failure. (Note: Patients with a history of miocardial infarction or coronary arterial bypass grafting more than 2 years prior to study start, without active angina, may participate.)
f.Patient has uncontrolled hypertension (Note: patients with medically controlled hypertension (diastolic blood pressure ≤ 95, systolic blood pressure ≤ 165)) may participate.
g.Within the previous 2 years, patient has a history of stroke, thromboembolic disease, transient ischemic attack, or active neurological disorder.
h.Patient has a history of hepatitis/hepatic disease that has been active within the previous 2 years.
i.Patient has a history of neoplastic disease; exception: (1) patients with adequately treated basal cell carcinoma or carcinoma in situ of the cervix may participate; (2) patients with other malignancies which have been successfully treated ≥10 years prior to screening, where in the judgment of both the investigator and treating physician, appropriate follow up has revealed no evidence of recurrence from the time of treatment through the time of screening; (3) patients, who, in the joint opinion of the Merck monitor and investigator, are highly unlikely to sustain a recurrence during the duration of the study. However, patients with a history of leukemia, lymphoma, malignant melanoma, myeloproliferative disease are ineligible for the study regardless of the time since treatment, and in such cases, no exceptions will apply.
j.Patients with evidence of occult GI bleeding as documented by any one positive stool Hemoccult screen obtained and read prior to allocation.
k.Patient will be excluded if the patient has had (1) one or more clinically apparent episodes of gastrointestinal bleeding within the past 5 years, or (2) more than one episode of ulcer disease documented by radiographic or endoscopic means within the past 5 years, or (3) any history of ulcer disease documented by radiographic or endoscopic means within 2 years prior to study entry, or (4) any history of esophageal or gastric variceal disease.
l.Patient is allergic to, or has a history of significant clinical or laboratory adverse experience associated with diclofenac; is allergic to paracetamol, or has hypersensitivity (e.g., bronchoconstriction in association with nasal polyps) to aspirin, ibuprofen, indomethacin and other NSAIDs. Note: patient with a history of potential idiosyncratic allergic reaction (e.g., rash) to a sin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method