NCT04968652|Completed
IBS-C Questionnaire Study
Evaluation of the Simplified Diagnosis Tool for Chinese IBS-C (Irritable Bowel Syndrome With Constipation) Patients
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Evaluation of the Simplified Diagnosis Tool for Chinese IBS-C (Irritable Bowel Syndrome With Constipation) Patients
Sponsor study identifier
observational
300
1 country
10
Study Start
November 1, 2021
Actual (reported)Primary Completion
October 28, 2022
Actual (reported)Study Completion
October 28, 2022
Actual (reported)The study is a multi-centre, observational study which enrolls 150 IBS-C patients and 150 non-IBS-C patients in China.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 28, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 28, 2021
Actual (reported)July 20, 2021
Actual (reported)November 1, 2021
Actual (reported)October 28, 2022
Actual (reported)October 28, 2022
Actual (reported)the sensitivity and specificity of the Simplified Diagnosis Tool for Chinese IBS-C patients
Sensitivity (%)=(number of patients judged as IBS-C based on both the Simplified Diagnosis Tool and the ROME IV)/( number of patients judged as IBS-C based on ROME IV) ×100% Specificity (%)=(number of patients judged as non-IBS-C based on both the Simplified Diagnosis Tool and ROME IV)/( number of patients judged as non-IBS-C based on The ROME IV) ×100%
14 months
the accuracy of the Simplified Diagnosis Tool
14 month
the Kappa coefficient of the Simplified Diagnosis Tool
14 months
the positive predictive value, and negative predictive value of the Simplified Diagnosis Tool
14 months
Result of ROME VI marked as 'IBS-C'.
Result of ROME VI marked as 'Non IBS-C'
With the ratio of IBS-C/non-IBS-C as 1:1, when the sample size is 300, assuming the sensitivity and specificity using ROME IV as reference are 0.85 and 0.85 respectively, a two-sided 95% confidence interval will produce confidence interval widths of 0.12 and 0.12 respectively. In addition, with the same assumption as above, a total sample size of 300 (which includes 150 subjects with the IBS-C) achieves 99% power to detect a change in sensitivity/ specificity from 0.7 to 0.85 using a two-sided binomial test. The target significance level is 0.05.
Research Site
Beijing, China
Research Site
Guangzhou, 510062, China
Research Site
Guangzhou, 510530, China
Research Site
Nanchang, 330006, China
Research Site
Nanjing, China
Research Site
Shanghai, China
Research Site
Shenyang, China
Research Site
Lishou Xiong
First Affiliated Hospital, Sun Yat-Sen University
300 participants (actual enrollment reported by the registry).
First Submitted
June 28, 2021
First Posted
July 20, 2021
Study Start
November 1, 2021
Actual (reported)Contact the study team to confirm eligibility.
Wenzhou, China
Research Site
Wuhan, 430022, China
Research Site
Zhengzhou, China
Primary Completion
October 28, 2022
Actual (reported)Study Completion
October 28, 2022
Actual (reported)Last Updated
December 28, 2023
Record last verified: 2023-12
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Source: ClinicalTrials.gov.
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