Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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16 December 2017 |
Main ID: |
NCT03185611 |
Date of registration:
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11/06/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Recurrence in Crohn's Disease
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Scientific title:
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Effectiveness of Rifaximin Combined With Thiopurine on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients With Risk Factor for Recurrence: A Multicenter Randomized Controlled Trial |
Date of first enrolment:
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May 18, 2017 |
Target sample size:
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120 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT03185611 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Xiang Gao, MD, PhD |
Address:
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Telephone:
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020-38663423 |
Email:
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gaoxiangmed@163.com |
Affiliation:
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Name:
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Xiang Gao, MD, PhD |
Address:
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Telephone:
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020-38663423 |
Email:
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gaoxiangmed@163.com |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Consecutive patients with Crohn's disease undergoing intestinal resection of all
macroscopic diseased bowel, with an endoscopically accessible ileocolic anastomosis;
2. Enrolled patients must have one or more risk factor for the development of
postoperative recurrence including penetrating disease behaviour, prior bowel
resection, and active smoking.
Exclusion Criteria:
1. Severe comorbidities;
2. With a stoma;
3. With malignancy;
4. Pregnancy;
5. Intolerant of thiopurine drugs;
6. With contraindication of using rifaximin or thiopurine drugs.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Drug: Azathioprine
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Drug: Rifaximin
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Primary Outcome(s)
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difference of incidence of endoscopic recurrence
[Time Frame: 6 months after surgery]
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Secondary Outcome(s)
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Adverse effect
[Time Frame: 6 months after surgery]
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Secondary ID(s)
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2017-ZSLY-06
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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