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NCT05213234 · ClinicalTrials.gov registry record · NA

Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis

A NA study of Ulcerative Colitis, sponsored by Rush University Medical Center.

Active
Registry status
NA
Development phase
32
Enrollment target
2
Study locations

NCT05213234 is a NA study of Ulcerative Colitis that is active but no longer recruiting, run by Rush University Medical Center. The registered enrollment target is 32 participants, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT05213234, a NA study of Ulcerative Colitis, is active but no longer recruiting, sponsored by Rush University Medical Center.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
32 participants
Enrollment target
2
Study locations

Study Summary

The hypothesis of this study is that appropriate time of day of administration of oral, once daily 5-ASA therapy in alignment with the host circadian rhythms will improve subclinical inflammation and microbial structure/function and increase mucosal 5-ASA levels. All subjects will be randomized to once daily 5-ASA medications at two different times of the day: between 06:00 - 10:00 h or 18:00 - 22:00 h. Three disease assessments will performed at: 1) enrollment just before randomization; 2) month 3, at the completion of first arm (Condition 1), and 3) month 6, after completion of the second arm (Condition 2). During these study time points, participants will be asked to complete questionnaires, track their 5-ASA medication usage, provide a stool sample, blood draw, urine test, collect saliva, wear a watch to measure sleep patterns, and complete a flexible sigmoidoscopy.

Conditions Studied

Ulcerative Colitis

Interventions

  • BEHAVIORAL Chronotherapy

Study Locations (2)

Illinois

  • Rush University Medical Center - Chicago

South Carolina

  • The Medical University of South Carolina - Charleston

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2021-07-09
Est. Completion 2026-03-31
Phase NA

Sponsor

Rush University Medical Center

320 total trials

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What the Registry Record Tells You About NCT05213234

The ClinicalTrials.gov registry entry for NCT05213234 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,057-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (98% lower). The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 1 intervention - of which Chronotherapy is the first listed.

NCT05213234 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Illinois, South Carolina.

Frequently Asked Questions

What is clinical trial NCT05213234 about?

NCT05213234 is a clinical study titled "Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis". The hypothesis of this study is that appropriate time of day of administration of oral, once daily 5-ASA therapy in alignment with the host circadian rhythms will improve subclinical inflammation and microbial structure/function and increase mucosal 5-ASA levels. All subjects will be randomized to ...

What is the current status of trial NCT05213234?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 32 participants. The study started on 2021-07-09. Estimated completion is 2026-03-31.

What conditions does trial NCT05213234 study?

This clinical trial studies the following conditions: Ulcerative Colitis.

What interventions are being tested in trial NCT05213234?

The interventions under investigation include: Chronotherapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT05213234?

This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05213234 being conducted?

This trial has 2 study locations across Illinois, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.