May. 29, 2024 |
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Sept. 11, 2024 |
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jRCT2031240126 |
TK-042 Phase III Clinical Study |
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TK-042 Phase III Clinical Study |
Nishiyama Kenichi |
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Teikoku Seiyaku Co., Ltd. |
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6-6, Nihonbashi Kobunacho, Chuo-ku, Tokyo |
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+81-3-6264-9123 |
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clinical_trial@teiyaku.co.jp |
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Clinical Development Department |
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Teikoku Seiyaku Co., Ltd. |
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6-6, Nihonbashi Kobunacho, Chuo-ku, Tokyo |
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+81-3-6264-9123 |
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clinical_trial@teiyaku.co.jp |
Not Recruiting |
July. 01, 2024 |
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July. 13, 2024 | ||
60 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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treatment purpose |
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- >= 7 to < 12 years of age. |
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- Have concomitant nasal disorders (e.g., nasal polyps, nasal septum deviation, hypertrophic rhinitis, etc.) or infectious diseases (e.g., upper respiratory tract inflammation, sinusitis, infectious rhinitis, eye infections, etc.) to a degree that would interfere with the efficacy evaluation. |
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7age old over | ||
12age old not | ||
Both |
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perennial allergic rhinitis |
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Placebo administered orally as 1 tablet once daily for 1 week, TK-042 administered orally as 1 tablet once daily for 12 weeks. |
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Safety endpoints (laboratory tests, vital signs, adverse events) |
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Teikoku Seiyaku Co., Ltd. |
Medical Corporation Shinanokai Shinanozaka Clinic Institutional Review Board | |
Yotsuya Medical Bldg. 3F, 20, Samon-cho, Shinjuku-ku, Tokyo, Tokyo | |
+81-3-5366-3006 |
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scl-irb@shinanokai.com | |
Approval | |
Medical Corporation Heishinkai OPHAC Hospital IRB | |
4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka, Tokyo | |
+81-6-6395-9000 |
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ophach_irb@heishinkai.com | |
Approval | |
No |
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none |