Analyzing the Factors in Ulcerative Colitis Patients' Clinical Trial Experiences
NCT ID: NCT05737836
Last Updated: 2023-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
500 participants
OBSERVATIONAL
2024-03-31
2026-03-31
Brief Summary
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This study will admit a wide range of data on the clinical trial experience of Ulcerative Colitis patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Ulcerative Colitis patients.
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Detailed Description
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Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Ulcerative Colitis
* Ability to understand the study procedures, benefits and risks, and sign a written informed consent document.
Exclusion Criteria
* Women who are pregnant, intend to become pregnant, or are lactating
* Inability to perform regular electronic reporting
18 Years
ALL
No
Sponsors
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Power Life Sciences Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael B Gill
Role: STUDY_DIRECTOR
Power Life Sciences Inc.
Central Contacts
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References
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Hindryckx P, Baert F, Hart A, Magro F, Armuzzi A, Peyrin-Biroulet L; Clinical Trial Committee Clincom of the European Crohn's and Colitis Organisation (ECCO). Clinical trials in ulcerative colitis: a historical perspective. J Crohns Colitis. 2015 Jul;9(7):580-8. doi: 10.1093/ecco-jcc/jjv074. Epub 2015 Apr 25.
Sebastian S, Walker GJ, Kennedy NA, Conley TE, Patel KV, Subramanian S, Kent AJ, Segal JP, Brookes MJ, Bhala N, Gonzalez HA, Hicks LC, Mehta SJ, Lamb CA; PROTECT-ASUC Study Group. Assessment, endoscopy, and treatment in patients with acute severe ulcerative colitis during the COVID-19 pandemic (PROTECT-ASUC): a multicentre, observational, case-control study. Lancet Gastroenterol Hepatol. 2021 Apr;6(4):271-281. doi: 10.1016/S2468-1253(21)00016-9. Epub 2021 Feb 2.
Feuerstein JD, Cheifetz AS. Ulcerative colitis: epidemiology, diagnosis, and management. Mayo Clin Proc. 2014 Nov;89(11):1553-63. doi: 10.1016/j.mayocp.2014.07.002. Epub 2014 Sep 8.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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80979547
Identifier Type: -
Identifier Source: org_study_id
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