A Randomized, Single blind, Prospective, Multi-center, Phase II, Clinical Study to Evaluate Efficacy and Safety of Three Different Topical Formulations in Subjects Suffering from Osteoarthritis of Knee(s) and Backache. - NI

Emami Ltd0 个研究点目标入组 180 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Pain in one or both knee joints due to OA for a minimum of six months and maximum for five years
•Low Back Pain without any serious medical/surgical condition for a minimum period of six months.
•History of knee pain or Low Back Pain requiring the use of NSAIDs Acetaminophen, or another analgesic agent on a regular basis for at least six months before the screening visit
•OA confirmed by radiographs and diagnosed according to ACR diagnostic Criteria (clinical and radiological) for the osteoarthritis of the knee(s)
•Subjects not having knee or severe Lumbar joint deformity
•Subjects signing written informed consent and ready to comply with the protocol requirement
•Subjects with pain VAS greater than 40 mm on weight bearing activities

•Rheumatoid arthritis, gout, pseudo gout, inflammatory arthritis, Pagets disease of bone, chronic pain syndrome, fibromyalgia, or another major joint disease
•Use of any analgesics except the study medication or paracetamol
•Use of systemic corticosteroids within 2 months of screening, or intraarticular viscosupplementation within the past 3 months
•Use of any other investigational drug within 1 month prior to randomization
•Subjects having uncontrolled diabetes mellitus, tuberculosis, HIV, Ischemic Heart Disease
•Known other active and serious medical or surgical disease
•Pregnancy and Lactation.
•Known hypersensitivity to ingredients used in study drug.

发起方

Emami Ltd