Double Blind Extension Study, Controlled with Active Comparator of 86 Weeks Duration of a 2-Part Study, Double Blind, Parallel Group, Placebo Controlled and Active Comparator to Evaluate the Safety and Efficacy of MK-0663 versus Naproxen in Patients Suffering Osteoarthritis

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2001年7月25日最近更新: 2023年9月4日

研究概览

暂无简介。

•The patient enrolled in Protocol 019 (base protocol) of MK-0663 and concluded Parts I and n according to the protocol until Visit 12.0 (Treatment Week 52).
•The patient meets all the inclusion criteria for Protocol 019 (base protocol) of MK-0663. (Note: If the patient did not meet all the entry criteria, but was included by a specific exception approved by Merck, the patient can also be enrolled in this extension).
•The patient tolerated the medicine from the baseline study and, in the opinion of the investigator and the clinical monitor, demonstrated compliance with the study procedures and medication.
•The patient understands the study procedures and agrees to participate in the study by signing the informed consent.
•Patients of childbearing age should demonstrate a b-hCG level in urine consistent with the non-pregnant state in Visit 12.0 / 14.0 and agree to follow a period of abstinence or use double-barrier contraceptives (the couple using a condom and the patient´s diaphragm) , contraceptive sponge or DTTT) during the study and until at least 14 days after the conclusion of treatment with the study medication.

•Patient who experienced serious or clinically important adverse experiences and / or was withdrawn for the same cause during Parts I and II of the base protocol, as determined by the investigator.

发起方

MERCK SHARP & DOHME PERU S.R.L.,