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Efficacy and safety of Imotun capsule in osteoarthritis of the knee
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Imotun | Active Comparator | 300.03mg/cap,orally, 1 capsule once daily for 24 weeks |
|
| Placebo | Placebo Comparator | 1 capsule once daily for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imotun | Drug | 300.03mg/cap,orally, 1 capsule once daily for 24 weeks |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by the incidence of adverse event | Safety assessed by the incidence of adverse event | up to 24weeks |
| laboratory test | laboratory test |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dae Hyun Yoo | Hanyang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym Universicy Sacred heart Hospital | Anyang | 431-070 | South Korea | |||
| Dong-A university Hospital |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D002214 | Capsules |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Placebo | Drug | 1 capsule once daily for 24 weeks |
|
| 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 |
| up to 24weeks |
| medication history | medication history | up to 24weeks |
| Busan |
| 602-715 |
| South Korea |
| Yeungnam university medical center | Daegu | 705-035 | South Korea |
| Chungnam National University hospital | Daejeon | 301-721 | South Korea |
| Chonnam National university medical school & Hospital | Gwangju | 501-757 | South Korea |
| hanyang University Guri Hospital | Gyeonggi-do | South Korea |
| Konkuk University Medical Center | Seoul | 143-729 | South Korea |
| Chung-Ang University hospital | Seoul | 156-755 | South Korea |
| Hanyang University Hospital | Special City of Seoul | South Korea |
| D012216 |
| Rheumatic Diseases |