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The purpose of this study is to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imotun capsule | Experimental | Imotun capsule: 300.03mg/cap, orally, 1 capsule once a day during 24 weeks |
|
| Imotun capsule placebo | Placebo Comparator | Imotun capsule Placebo: Placebo 1 capsule once a day during 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imotun capsule | Drug | Imotun capsule: Avocado-Soya Unsaponifiables 300.03mg/Cap, per oral, a capsule once a day during for 24 weeks |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| rate of adverse event | up to 24 weeks | |
| laboratory test | up to 24 weeks | |
| medication history |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myung Chul Lee, phD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk National University Hospital | Cheongju-si | Chungcheonbuk-do | South Korea | |||
| Inje University Busan Paik Hospital |
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| Imotun capsule placebo | Drug | Imotun capsule placebo: per oral, a capsule a day during 24 weeks |
|
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 |
| up to 24 weeks |
| Busan |
| 633-165 |
| South Korea |
| Kyungpook National University Hospital | Daegu | 700-721 | South Korea |
| Chonnam National University Hwasun hospital | Hwasun | 519-763 | South Korea |
| Chonbuk National University Hospital | Jeonju | 561-712 | South Korea |
| Bundang CHA medical center | Seongnam | 463-712 | South Korea |
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
| KyungHee University Medical Center | Seoul | 130-872 | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| ASAN Medical Center | Seoul | 138-736 | South Korea |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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