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To preliminarily evaluate the clinical efficacy of the renin inhibitor SPH3127 Tablets in patients with mild to moderate ulcerative colitis with placebo as a control and determine the recommended dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPH3127 Tablets with Dose A | Experimental | Oral daily dose of SPH3127 Tablets for up to 8 weeks |
|
| SPH3127 Tablets with Dose B | Experimental | Oral daily dose of SPH3127 Tablets for up to 8 weeks |
|
| SPH3127 Tablets placebo | Placebo Comparator | Oral daily dose of SPH3127 Tablets placebo for up to 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPH3127 Tablets with Dose A | Drug | See Arm description |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom remission rate | Symptom remission rate | Week8 |
| Endoscopic remission rate | Endoscopic remission rate | Week8 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission rate | Clinical remission rate | Week8 |
| Symptom remission rate | Symptom remission rate | Week2、Week4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital,Sun Yat-sen University | Guangzhou | Guangdong | 510080 | China | ||
| The Sixth Affiliated Hospital, Sun Yat-sen University |
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| SPH3127 Tablets with Dose B |
| Drug |
See Arm description |
|
| SPH3127 Tablets placebo | Drug | See Arm description |
|
| Safety and tolerability since the start of any study treatment. | Incidence of adverse event and serious adverse event , correlation with study drug | Approximately 3 months |
| Guangzhou |
| Guangdong |
| 510655 |
| China |
| Huizhou First Hospital | Huizhou | Guangdong | China |
| Nanfang Hospital, Southern Medical University | Guangzhou | Guanmgdong | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | He'nan | China |
| Affiliated Hospital of Hebei University | Baoding | Hebei | China |
| The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei | China |
| The First Affiliated Hospital of Henan University | Kaifeng | Henan | China |
| Union Hospital Tongji Medical College Huazhong Universitu of Science and Technology | Wuhan | Hubei | 430000 | China |
| Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
| The First Hospital of Hunan University of Chinese Medicine | Changsha | Hunan | China |
| The First Affiliated Hospital of University of South China | Hengyang | Hunan | 675299 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221000 | China |
| Shengjing Hospital affiliated to China Medical University | Shenyang | Liaoning | 110136 | China |
| General Hospital of Ningxia Medical University | Yinchuan | Ningxia | 750004 | China |
| Shandong Provincial Hospital Affiliated to Shandong First Medical University | Jinan | Shandong | China |
| Xi'an Central Hospital | Xi’an | Shanxi | China |
| Suining Central Hospital | Suining | Sichuan | China |
| Beijing Chao-Yang Hospital,Capital Medical University | Beijing | 100020 | China |
| Peking University Third Hospital | Beijing | China |
| Chifeng Municipal Hospital | Chifeng | China |
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | 310003 | China |
| Shanghai Jiaotong University School of Medicine, Renji Hospital | Shanghai | 200001 | China |
| Tianjin Medical University General Hospital; | Tianjin | 300052 | China |
| ID | Term |
|---|---|
| C000709209 | SPH3127 |
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