Analyzing the Factors in Ulcerative Colitis Patients' Clinical Trial Experiences

NCT05737836 | Not Yet Recruiting

• 1 other identifier: 80979547
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Taking part in clinical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. 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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis

Outcome Measures

Primary Outcomes (2)

• Rate of patients who decide to join in an Ulcerative Colitis clinical trial

  3 months

• Number of Ulcerative Colitis patients who remain in clinical trial until completion

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Ulcerative Colitis patients who are actively considering involvement in a clinical trial, but have not yet completed enrollment and registration.

You may qualify if:

• Patient is at least 18 years of age
• Diagnosis of Ulcerative Colitis
• Ability to understand the study procedures, benefits and risks, and sign a written informed consent document.

You may not qualify if:

• Inability to perform regular electronic reporting
• Women who are pregnant, intend to become pregnant, or are lactating
• Inability to perform regular electronic reporting

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• 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.

  PMID: 25913641 BACKGROUND

• 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.

  PMID: 33545083 BACKGROUND

• 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.

  PMID: 25199861 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

415-900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: February 21, 2023
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2026
• Last Updated: June 12, 2023

Record last verified: 2023-06