A Phase III, Multicenter, Randomized, Open Label, Parallel Group, Comparative Clinical Study To Evaluate The Efficacy And Safety of Aceclofenac Topical Gel 5% w/w Compare with HIFENAC GELÂ® 1.5% w/w For The Treatment of Sprain and Muscle Pain

Inventia Healthcare Private Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. Patients of either sex between 18-65 years of age.
•2. Patients with painful sprain and/or muscle pain.
•3. Patients with at least moderate pain of Visual Analogue Scale (VAS) greater or equal to 3.
•4. Patient is able to provide written informed consent prior to study.
•5. Willingness to comply with the study schedule and procedures.

•1. Patients with any condition which in opinion of the investigator makes the patient unsuitable for inclusion.
•2. Patients with painful muscle spasms associated with musculoskeletal systems, which need parenteral therapy / surgery / hospital admission for management.
•3. Patient with history of osteoarthritis / rheumatoid arthritis.
•4. Patients with skin wounds, open injuries or other conditions of broken skin at the site of proposed application.
•5. Use of any oral or topical analgesic or anti-inflammatory treatment within 1 week prior to study.
•6. Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient.
•7. Patients with history of severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
•8. Known hypersensitivity to aspirin, aceclofenac or any other ingredient of product.
•9. Patient is a female who is pregnant or willing to get pregnant, not ready to use contraceptive measures during the trial period or breast feeding.
•10. Participation in any other clinical trial during last 30 days.

发起方

Inventia Healthcare Private Limited