Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Efficacy and safety of Imotun capsule in osteoarthritis of the knee

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chong Kun Dang Pharmaceutical

Criteria

Inclusion Criteria:

• Agreement with written informed consent and 40 years of age and older

• Patients with more than 63months history of OA of knee according to ACR criteria

• Radiographic evidence of Kellgren & Lawrence grade II to III OA of the knee

• The 100mm Pain VAS is over 40mm

• The Lequensne's index is over 5

Exclusion Criteria:

• Treatment with SYSADOA within 3 months

• History of joint surgery within 5 years or Arthroscopic surgery within 1year

• Intra-articular injections within 3 months

• Treatment with NASIDs within 7 days

• Any history of adverse reaction to the study drugs

• clinically significant hepatic, renal, cardiovascular diseases

• Patients with gastrointestinal ulcers or bleeding disorders

• Pregnant women, nursing mothers or Fertile women who not practice contraception with appropriate methods

• History of drug abuse or alcoholism

• Patients on any other clinical trial or experimental treatment in the past 4 weeks

• An impossible one who participates in clinical trial by investigator's decision