Study identifier:D5630R00002
ClinicalTrials.gov identifier:NCT04968652
EudraCT identifier:N/A
CTIS identifier:N/A
Evaluation of the Simplified Diagnosis Tool for Chinese IBS-C (irritable bowel syndrome with constipation) patients
irritable bowel syndrome with constipation
N/A
No
-
All
327
Observational
18 Years - n/a
Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -
Verified 01 Nov 2022 by AstraZeneca
AstraZeneca
The First Affiliated Hospital, Sun Yat-sen University, The Third Affiliated Hospital, Sun Yat-sen University, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, The First Affiliated Hospital of Nanchang University, Henan Provincial People's Hospital, Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School, Wuhan Union Hospital of China, Peking University First Hospital, The First Affiliated Hospital of Anhui Medical University, Shengjing Hospital
The study is a multi-centre, observational study which enrolls 150 IBS-C patients and 150 non-IBS-C patients in China.
The potential study subject will be identified by the investigators by face-to-face visit, and there will be only 1 visit in this study. Every patient will complete both ROME IV and the Simplified Diagnosis Tool during the visit, and in the same day. The study will collect results of the ROME IV and the Simplified Diagnosis Tool. Sensitivity and specificity of simplified diagnosis methodology compared with ROME IV will be analysed after all the data has been collected.
Location
Location
Guangzhou, China, 510062
Location
Guangzhou, China, 510530
Location
Wuhan, China, 430022
Location
Nanchang, China, 330006
Location
Shanghai, China
Location
Beijing, China
Location
Zhengzhou, China
Location
Nanjing, China
Arms | Assigned Interventions |
---|---|
IBS-C Group Result of ROME VI marked as ‘IBS-C’. | - |
Non IBS-C Group Result of ROME VI marked as ‘Non IBS-C’ | - |
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