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The purpose of this study is to determine the optimal dose of AD-211 in patients with osteoarthritis of the knee.
Osteoarthritis of the knee
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AD-211-L Group | Experimental | 1 Week: twice daily; 2 tablets per dose (AD-211-L + placebo to AD-2113). 12 Weeks: twice daily; 3 tablets per dose (AD-211-L + placebo to AD-211-H + placebo to AD-2113). |
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| AD-211-M Group | Experimental | 1 Week: twice daily; 2 tablets per dose AD-211-M + placebo to AD-2113). 12 Weeks: twice daily; 3 tablets per dose (AD-211-M + placebo to AD-211-H + placebo to AD-2113). |
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| AD-211-H Group | Experimental | 1 Week: twice daily; 2 tablets per dose (AD-211-M + placebo to AD-2113). 12 Weeks: twice daily; 3 tablets per dose (AD-211-H + placebo to AD-211-L/M + placebo to AD-2113). |
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| AD-2113 Group | Active Comparator | 1 Week: twice daily; 2 tablets per dose (AD-2113 + placebo to AD-211-L/M). 12 Weeks: twice daily; 3 tablets per dose (AD-2113 + placebo to AD-211-L/M + placebo to AD-211-H). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AD-211-L | Drug | Per oral, 1 tablet twice daily during the treatment period. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in 100 mm Pain VAS score during activity over the past 24 hours in the target knee | Baseline to Week13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyeji Lee | Contact | +82318915604 | hjlee@addpharma.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jung Yoon Choi | Daegu Catholic University Medical Center | Principal Investigator |
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| AD-211-M |
| Drug |
Per oral, 1 tablet twice daily during the treatment period. |
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| AD-211-H | Drug | Per oral, 1 tablet twice daily during the treatment period. |
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| AD-2113 | Drug | Per oral, 1 tablet twice daily during the treatment period. |
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| Placebo to AD-211-L/M | Drug | Per oral, 1 tablet twice daily during the treatment period. |
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| Placebo to AD-211-H | Drug | Per oral, 1 tablet twice daily during the treatment period. |
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| Placebo to AD-2113 | Drug | Per oral, 1 tablet twice daily during the treatment period. |
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