A randomized, controlled, double-blind, double-dummy clinical trial to evaluate the safety and efficacy of Loxoprofen Sodium Cataplasm ointment (Loxonin;PAP100mg) against myalgia

ead Chemical Co. Ltd (Japan)0 个研究点目标入组 160 人开始时间: 2014年12月29日最近更新: 2019年3月4日

试验速览

•1. Age: > 18 years, < 80 years, 18 and 80 years included
•2. Either sex
•3. Any of the following with moderate intensity: resting pain, pressing pain, exercising pain
•4. The patients were not treated by drugs for one week before giving the investigational product, and no change in physiotherapy for 2 weeks during the first treatment.
•5. Patients agree to participate in the trial and sign informed content form after completely understanding the contents of the clinical trial

•1. Patient's pain caused by external injury and diagnosed as acute
•2. Patient's pain diagnosed as neurosis
•3. Patients with lesions, poor skin conditions on pasting site, or with cutaneous anaphylaxis
•4. Patients who need steroid drugs or other non-steroid analgesics which may interfere the therapeutic method in this clinical trial.
•5. Patient with peptic ulcer.
•6. Patients with bronchial asthma.
•7. Patients with serious cardiac diseases, hepatic diseases (ALT, AST are equal or bigger than 2.5 times of upper limit), renal diseases (creatinine is equal or bigger than 1.5 times of upper limit), hematologic disease, diabetes, mental diseases, and other serious complications.
•8. Pregnant women, lactating mothers or patients who have the possibility of pregnancy, and want to be pregnant during the trial.
•9. Patient allergic to this drug.
•10. Patients participating any clinical trials on investigational drug or marketed drug within 3 months before enrollment or during clinical trial
•11. Other patients judged to be inappropriate for this clinical trial by the investigator

发起方

ead Chemical Co. Ltd (Japan)