Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05213234 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Chronotherapy of 5-Aminosalicylic Acid in Ulcerative Colitis

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 4 months later Aug 30, 2026 → Dec 30, 2026
See other at-risk trials from Rush University Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 30, 2026 to Dec 30, 2026
    • Study completion pushed from Sep 30, 2026 to Dec 30, 2026
    • Eligibility criteria expanded, about 19 words
  2. Primary completion pushed from Jun 30, 2026 to Aug 30, 2026
    • Study completion pushed from Jun 30, 2026 to Sep 30, 2026
    v14
  3. Primary and study completion dates: Mar 31, 2026 to Jun 30, 2026
    • Eligibility criteria shortened, about 14 words
    v13
  4. Re-verified, no change to tracked fieldsv12
  5. Enrollment target: 60 to 32
    • Primary and study completion dates: Jun 30, 2025 to Mar 31, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 2 of 2 sites
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary and study completion dates: Oct 31, 2024 to Jun 30, 2025v10
  2. Eligibility criteria expanded, about 27 words
    • Site details revised at 1 of 2 sites
    v9
  3. Primary completion date: Mar 29, 2024 to Oct 31, 2024
    • Study completion date: Apr 30, 2024 to Oct 31, 2024
    v8
  4. Primary completion date: Dec 31, 2023 to Mar 29, 2024
    • Study completion date: Mar 31, 2024 to Apr 30, 2024
    v7
  5. Primary completion date: Apr 1, 2024 to Dec 31, 2023
    • Study completion date: Sep 30, 2024 to Mar 31, 2024
    v6
  6. Study sites: 1 to 2
    • Primary completion date: Dec 31, 2023 to Apr 1, 2024
    • Study completion date: Mar 31, 2024 to Sep 30, 2024
    v5
  7. Re-verified, no change to tracked fieldsv4
  8. Eligibility criteria shortened, about 12 words
    • Site contact updated
    v3
  9. Primary completion date: Aug 17, 2024 to Dec 31, 2023
    • Study completion date: Aug 17, 2025 to Mar 31, 2024
    • Start date: Aug 17, 2021 to Jul 9, 2021
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 1, at the completion of first arm (Condition 1), and 3) month 3, 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.
Trial Details
NCT Number NCT05213234
Lead Sponsor Rush University Medical Center
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions
(from sponsor)		 Ulcerative Colitis
Related terms Colitis, Ulcerative
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov