STUDY OF CLINICAL DOCUMENTATION, CONTROLLED, DOUBLE-BLIND, RANDOMIZED, MULTICENTER, DESIGNED TO EVALUATE THE EFFECTIVENESS AND TOLERANCE OF FIXED COMBINATION OF THIOCOLCHICOSIDE PLUS DICLOFENAC POTASSIUM IN REDUCTION OF ACUTE PAINFUL MUSCLE CONTRACTURE

Gutis Ltda. San Jose, Costa Rica0 个研究点目标入组 90 人开始时间: 2013年6月20日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•1. Ambulatory subjects suffering from acute muscle spasm recent (= 72 hours), with visible striated muscle spasm, with or without fixed-antalgic attitude (Rating on a scale of visual assessment of muscle contracture of 2 or 3) secondary to conditions such as neck pain, backache, low back pain, etc. and / or 2. Subjects showing an intensity of at least moderate pain, showing a minimum in the visual analog scale (VAS) ? to 4 cm. 3. Subjects over 18 years and under 60 years of age. 4. Subjects with good health, confirmed by: a. Medical history and prior medication, and b. Baseline physical examination, including vital signs 5. Subjects able to take oral medication. 6. Subjects who agree to, and shall be able to: a. Read and understand written instructions, and b. Complete the Patient's Journal. 7. Subjects after a full explanation of the study, understand the nature of it and agree to sign informed consent to participate in it. 8. The first patients, according to the number assigned to each researcher, who meet the above requirements within the time of recruitment.

•1. Subjects younger than 18 or older than 60 years and in general subjects not meeting inclusion criteria 2. Subjects in whom treatment with thiocolchicoside and / or diclofenac potassium has previously failed. 3. Subjects who have discontinued treatment with thiocolchicoside and / or diclofenac potassium or any NSAID due to adverse reactions. 4. Subjects who have taken thiocolchicoside and / or diclofenac potassium in the 7 days prior to inclusion in the study. 5. Subjects suffering from severe systemic disease to more the muscle contracture. 6. Subjects who have taken any other medication for a specific medical condition or disease within the past 7 days before inclusion in the study. 7. Subjects with a history of: a. Convulsions, seizures or epilepsy risk b. Significant renal or hepatic function abnormal, which could compromise the welfare of the subjects or mask the results of the study, c. Gastrointestinal bleeding 8. Subjects as precautions, warnings or contraindications included in the monograph thiocolchicoside and / or diclofenac potassium and according to the investigator's opinion should not be included in the study 9. Subjects with a history of substance abuse or chronic alcohol abuse. 10. Pregnant or breast-feeding. 11. Women of childbearing age in which they may suspect the possibility of pregnancy (LMP, anamnesis and if necessary test to exclude pregnancy)

发起方

Gutis Ltda. San Jose, Costa Rica