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最高研发阶段批准上市 |
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首次获批日期2001-01-01 |
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非在研适应症- |
最高研发阶段临床2期 |
首次获批国家/地区- |
首次获批日期- |
Efficacy and Tolerability Study of Natura-Alpha in the Treatment of Patients With Active Ulcerative Colitis
This study is to evaluate the efficacy and tolerability of multiple oral doses of Natura-alpha capsule administered to patients with active ulcerative colitis. This will be a randomized, double-blind, placebo-controlled, parallel-design study. Up to 75 patients will complete this study (20 to 25 patients per treatment group) at approximately 10-12 clinical sites in the Unites States. Patients will be assigned at a 1:1:1 ratio to receive placebo, Natura-alpha 10 mg or Natura-alpha 20 mg, b.i.d. Replacement patients may be added, pending Sponsor approval, if it appears that less than 60 patients will complete the study.
100 项与 Natrogen Therapeutics International, Inc. 相关的临床结果
0 项与 Natrogen Therapeutics International, Inc. 相关的专利(医药)
100 项与 Natrogen Therapeutics International, Inc. 相关的药物交易
100 项与 Natrogen Therapeutics International, Inc. 相关的转化医学