Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee

Phase 4

Completed

Brief Summary: Efficacy and safety of Imotun capsule in osteoarthritis of the knee

Detailed Description: A six-month, multi center, randomizied, double blind, parallel-group,placebo controlled study to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Imotun	Imotun	300.03mg/cap,orally, 1 capsule once daily for 24 weeks
Placebo	Placebo	1 capsule once daily for 24 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in the Lequesne's index score at 24weeks	baseline, 24 weeks	Change from baseline in the Lequesne's index score at 24weekS
100mm Pain VAS	24 weeks	assessment of 100mm Pain VAS (24weekS)

Secondary Outcome Measures

Name	Time	Method
Change from baseline Lequesne's index score at 4weeks	baseline, 4 weeks	Change from baseline Lequesne's index score at 4weeks
dosing quantity of the rescue medication	24weeks	dosing quantity of the rescue medication
Global assement (Patient, Physician)	24weeks	-Global assement (Patient, Physician)
change from baseline 100mm Pain VAS at 8weeeks	baseline, 8weeks	change from baseline 100mm Pain VAS at 8weeeks
Change from baseline Lequesne's index score at 8weeks	baseline, 8 weeks	Change from baseline Lequesne's index score at 8weeks
Change from baseline Lequesne's index score at 16weeks	baseline, 16 weeks	Change from baseline Lequesne's index score at 16weeks
The rate of patients who consumed the rescue medication	24weeks	The rate of patients who consumed the rescue medication
100mm Pain VAS	16weeks	- Patient's assessment of 100mm Pain VAS
change from baseline 100mm Pain VAS at 24weeeks	baseline, 24 weeks	change from baseline 100mm Pain VAS at 24weeeks
change from baseline Global assement (Patient, Physician)	baseline, 16weeks	-Global assement (Patient, Physician)
administration days of the rescue medication	24weeks	administration days of the rescue medication
change from baseline 100mm Pain VAS at 4weeeks	baseline, 4weeks	change from baseline 100mm Pain VAS at 4weeeks
change from baseline 100mm Pain VAS at 16weeeks	baseline, 16 weeks	change from baseline 100mm Pain VAS at 16weeeks

Locations (9): Yeungnam university medical center
🇰🇷
Daegu, Korea, Republic of
hanyang University Guri Hospital
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Gyeonggi-do, Korea, Republic of
Chung-Ang University hospital
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Seoul, Korea, Republic of
Chungnam National University hospital
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Daejon, Korea, Republic of
Hallym Universicy Sacred heart Hospital
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Anyang, Korea, Republic of
Dong-A university Hospital
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Busan, Korea, Republic of
Chonnam National university medical school & Hospital
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Gwangju, Korea, Republic of
Hanyang University Hospital
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Special City of Seoul, Korea, Republic of
Konkuk University Medical Center
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Seoul, Korea, Republic of