Mild to Moderate Ulcerative Colitis Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Dose-finding Phase II Clinical Study to Evaluate the Efficacy and Safety of SPH3127 Tablets in the Treatment of Mild to Moderate Ulcerative Colitis
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.
Status | Recruiting |
Enrollment | 108 |
Est. completion date | February 15, 2025 |
Est. primary completion date | February 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Aged 18 - 75 years, male or female; 2. Subjects who have been diagnosed with ulcerative colitis; 3. Subjects who agree to take effective contraceptive measures with their spouses throughout the study period and for up to 12 weeks after the last dose; 4. Subjects who thoroughly learn about the nature, significance, possible benefits, possible inconvenience and potential risks of the trial, understand the study procedures and voluntarily sign the informed consent form prior to their participation in the trial. Exclusion Criteria: 1. Subjects who are diagnosed with Crohn's disease or indeterminate colitis; 2. Subjects with active infections at screening which may, as evaluated by the investigator, cause increased risks for subjects; 3. Subjects who had surgery that might impact the absorption of oral drugs, subjects who will undergo surgery during the study period, subjects who have undergone major surgery before screening, or subjects who have a plan of surgery during the study period; 4. Subjects and lactating women and those who will become pregnant within 6 months after the trial starts; 5. Subjects with a history of drug abuse with clinical significance within 1 year prior to screening; 6. Subjects with other diseases or conditions that the investigator considers unsuitable for this trial. |
Country | Name | City | State |
---|---|---|---|
China | Affiliated Hospital of Hebei University | Baoding | Hebei |
China | Beijing Chao-Yang Hospital,Capital Medical University | Beijing | |
China | Peking University Third Hospital | Beijing | |
China | The First Hospital of Hunan University of Chinese Medicine | Changsha | Hunan |
China | Chifeng Municipal Hospital | Chifeng | |
China | Nanfang Hospital, Southern Medical University | Guangzhou | Guanmgdong |
China | The First Affiliated Hospital,Sun Yat-sen University | Guangzhou | Guangdong |
China | The Sixth Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong |
China | The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | |
China | The First Affiliated Hospital of University of South China | Hengyang | Hunan |
China | Huizhou First Hospital | Huizhou | Guangdong |
China | Shandong Provincial Hospital Affiliated to Shandong First Medical University | Jinan | Shandong |
China | The First Affiliated Hospital of Henan University | Kai Feng | Henan |
China | Shanghai Jiaotong University School of Medicine, Renji Hospital | Shanghai | |
China | Shengjing Hospital affiliated to China Medical University | Shenyang | Liaoning |
China | The Second Hospital of Hebei Medical University | Shijiazhuang | Hebei |
China | Suining Central Hospital | Suining | Sichuan |
China | Tianjin Medical University General Hospital; | Tianjin | |
China | Renmin Hospital of Wuhan University | Wuhan | Hubei |
China | Tongji Hospital Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei |
China | Union Hospital Tongji Medical College Huazhong Universitu of Science and Technology | Wuhan | Hubei |
China | Xi'an Central Hospital | Xi'an | Shanxi |
China | The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu |
China | General Hospital of Ningxia Medical University | Yinchuan | Ningxia |
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Shanghai Pharmaceuticals Holding Co., Ltd |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptom remission rate | Symptom remission rate | Week8 | |
Primary | Endoscopic remission rate | Endoscopic remission rate | Week8 | |
Secondary | Clinical remission rate | Clinical remission rate | Week8 | |
Secondary | Symptom remission rate | Symptom remission rate | Week2?Week4 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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