The Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate 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:

• Female and male patients who aged 40 or more and agreement with written informed consent

• Patients with osteoarthritis according to ACR criteria lasted for the past 3 months or more

• Patients with Kellgren & Lawrence grade Ⅱ~Ⅲ on radiographs

• Patients with 40mm or higher 100mm Pain VAS on screening and baseline visit (based on more painful knee)

• Patients with Lequesne's index 5 or more on screening and baseline visit

Exclusion Criteria:

• Patients who had taken SYSADOA within the past 3 months (Imotun, diacerein, s-adenosyl-methionone, JOINS, glucosamine, chondroitin and any other cartilage protective agents determined by investigator)

• Patients who experienced cartilage surgery within the past 5 years or arthroscope surgery within a year(one side or both)

• Patients who were treated with joint space injection within the past 3 months

• Patients who had taken NSAIDs including pain killers within 7 days (except, it is acceptable to enroll the study if the patients have wash out periods at least 7 days before randomization)

• Patients with hypersensitivity or allergy to the study or rescue medicine or those who have medical history.

• Patients with severe liver, kidney or cardiac diseases who are not acceptable for the study determined by investigator

• Patients with active peptic ulcer or GI bleeding.

• Pregnancy, nursing women or women of reproductive age who do not agree to the contraception.

• Patients with abuse of alcohol, illegal drugs or drug dependency

• Patients who were treated with another investigational product within the past 4 weeks

• All other patients who are not acceptable for the study determined by investigator