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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 January 2023 |
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Main ID: |
NCT03915262 |
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Date of registration:
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09/04/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease
IPEC |
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Scientific title:
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Exocrine Pancreatic Insufficiency's Prevalence in Active Crohn's Disease Treated by Biological Therapy |
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Date of first enrolment:
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November 15, 2019 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03915262 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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France
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Contacts
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Name:
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Gilles BOSCHETTI, MD |
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Address:
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Telephone:
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478860302 |
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Email:
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gilles.boschetti@chu-lyon.fr |
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Affiliation:
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Name:
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Gilles BOSCHETTI |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospices Civils de Lyon |
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Name:
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Gilles BOSCHETTI, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age of 18 years or more
- Crohn's disease diagnosed for more than 3 months.
- Active Crohn's disease : CDAI score > 150 + [CRP > 5 mg/L or faecal calprotectin >
250mcg/g or endoscopic lesion or MRI lesion]
- Indication of a biological therapy (anti-TNFa, vedolizumab ou ustekinumab).
Exclusion Criteria:
- Crohn's disease that doesn't fit the previous criteria
- Extended resection of small intestine (>40cm)
- Chronic pancreatitis diagnosed before inclusion
- Contraindication to biological therapy (anti-TNFa, vedolizumab ou ustekinumab)
- Pancreatic enzyme replacement therapy
- Pregnant or breastfeeding woman
- Patient under the protection of a conservator
Age minimum:
18 Years
Age maximum:
N/A
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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Biological: Search for exocrine pancreatic insufficiency at week 0 and 12
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Primary Outcome(s)
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Exocrine pancreatic insufficiency's prevalence
[Time Frame: week 14]
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Exocrine pancreatic insufficiency's prevalence
[Time Frame: week 0]
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Secondary ID(s)
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69HCL19_0294
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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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