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

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

Detailed Description
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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.

Official Title
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A Six-month, Multi Center, Randomized, Double Blind, Parallel-group, Placebo Controlled Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: Imotun capsule
* Drug: Imotun capsule placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imotun capsule<br>Imotun capsule: 300.03mg/cap, orally, 1 capsule once a day during 24 weeks | Drug: Imotun capsule<br>* Imotun capsule: Avocado-Soya Unsaponifiables 300.03mg/Cap, per oral, a capsule once a day during for 24 weeks<br>|
| Placebo Comparator: Imotun capsule placebo<br>Imotun capsule Placebo: Placebo 1 capsule once a day during 24 weeks | Drug: Imotun capsule placebo<br>* Imotun capsule placebo: per oral, a capsule a day during 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100mm pain VAS | assessment of the 100mm pain VAS | 24 weeks | 
| change from baseline Lequesne's index score at 24 weeks |  | baseline, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | assessment of 100mm pain VAS | 4 weeks | 
| global assessment | global assessment by physician and patient | 4 weeks | 
| 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 | 
| change from baseline 100mm pain VAS at 24 weeks |  | baseline, 24 weeks | 
| 100mm pain VAS | assessment of 100mm pain VAS | 8 weeks | 
| 100mm pain VAS | assessment of 100mm pain VAS | 16 weeks | 
| global assessment | global assessment by physician and patient | 8 weeks | 
| global assessment | global assessment by physician and patient | 16 weeks | 
| global assessment | global assessment by physician and patient | 24 weeks | 
| dosing quantity of the rescue medication |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis of the knee