Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee

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

Detailed Description
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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

Official Title
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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

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: Imotun
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

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 |
| --- | --- |
| Active Comparator: Imotun<br>300.03mg/cap,orally, 1 capsule once daily for 24 weeks | Drug: Imotun<br>* 300.03mg/cap,orally, 1 capsule once daily for 24 weeks<br>* Other names: Avocado-Soya Unsaponifiables 300.03mg/Cap;|
| Placebo Comparator: Placebo<br>1 capsule once daily for 24 weeks | Drug: Placebo<br>* 1 capsule once daily for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Lequesne's index score at 24weeks | Change from baseline in the Lequesne's index score at 24weekS | baseline, 24 weeks | 
| 100mm Pain VAS | assessment of 100mm Pain VAS (24weekS) | 24 weeks | 

Secondary Outcome Measures

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

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