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

Phase 4

Completed

Brief Summary: The purpose of this study is to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee

Detailed Description: This is a six-month, multicenter, randomized, double blind, parallel-group,placebo controlled study. Patients take Imotun capsules or placebo once a day, between the meals. Patients are allowed to take study drugs during the meal in the case of intolerant reflux of oil smell from GI. If patients do not tolerate the pain, they are able to take Celecoxib as a rescue medication during 6 months.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Imotun capsule	Imotun capsule	Imotun capsule: 300.03mg/cap, orally, 1 capsule once a day during 24 weeks
Imotun capsule placebo	Imotun capsule placebo	Imotun capsule Placebo: Placebo 1 capsule once a day during 24 weeks

Primary Outcome Measures

Name	Time	Method
100mm pain VAS	24 weeks	assessment of the 100mm pain VAS
change from baseline Lequesne's index score at 24 weeks	baseline, 24 weeks

Secondary Outcome Measures

Name	Time	Method
change from baseline Lequesne's index score at 4 weeks	baseline, 4 weeks
change from baseline 100mm pain VAS at 4 weeks	baseline, 4 weeks
100mm pain VAS	16 weeks	assessment of 100mm pain VAS
global assessment	24 weeks	global assessment by physician and patient
administration days of the rescue medication	24 weeks
The rate of patients who consumed the rescue medication	24 weeks
change from baseline Lequesne's index score at 8 weeks	baseline, 8 weeks
change from baseline Lequesne's index score at 16 weeks	baseline, 16 weeks
change from baseline 100mm pain VAS at 8 weeks	baseline, 8 weeks
change from baseline 100mm pain VAS at 16 weeks	baseline, 16 weeks
dosing quantity of the rescue medication	24 weeks
change from baseline 100mm pain VAS at 24 weeks	baseline, 24 weeks

Locations (10): Chonbuk National University Hospital
🇰🇷
Jeonju, Korea, Republic of
Bundang CHA medical center
🇰🇷
Seongnam, Korea, Republic of
Seoul National University Hospital
🇰🇷
Seoul, Korea, Republic of
KyungHee University Medical Center
🇰🇷
Seoul, Korea, Republic of
Chonnam National University Hwasun hospital
🇰🇷
Hwasun, Korea, Republic of
Samsung Medical Center
🇰🇷
Seoul, Korea, Republic of
Chungbuk National University Hospital
🇰🇷
Cheongju, Chungcheonbuk-do, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷
Busan, Korea, Republic of
Kyungpook National University Hospital
🇰🇷
Daegu, Korea, Republic of
ASAN Medical Center
🇰🇷
Seoul, Korea, Republic of