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NCT04304950 · ClinicalTrials.gov registry record · Phase 4
Chronotherapy in Inflammatory Bowel Disease
A Phase 4 study, sponsored by Rush University Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
NCT04304950: Completed Phase 4 study, sponsored by Rush University Medical Center.
NCT04304950 is a Phase 4 study that has completed, run by Rush University Medical Center. The registered enrollment target is 28 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04304950, a Phase 4 study, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
Study Summary
This study aims to determine if there is any difference in the efficacy of Inflammatory Bowel Disease (IBD) medication and disease outcomes when taken in the morning or in the evening. The IBD medications being observed are azathioprine and 6-mercaptopurine. The study team believes that there may be a benefit to taking the medication at a certain time of day. To test this theory the study asks participants who are already taking either azathioprine or 6-mercaptopurine for IBD to take the medication consistently at either the morning or in the evening based on when they currently take their medication. Participation is up to 10 weeks +/- 3 days. There will be 2 study visits where the participant will be asked to fill in questionnaires related to their IBD symptoms, their sleep habits, sleep quality, and general health information followed by a blood draw.
Primary Outcome
This is to examine if the intervention results in a greater level of thioguanine in the participants. If so, the participants are expected to have less symptom severity. Comparing baseline taken at visit one to visit two levels 10 weeks after intervention start.
Interventions
- DRUG Evening Group
- DRUG Morning Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2016-04-25 |
| Est. Completion | 2023-04 |
| Phase | Phase 4 |
What the finished NCT04304950 record still lists
NCT04304950 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Evening Group is the first listed.
NCT04304950 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04304950 about?
NCT04304950 is a clinical study titled "Chronotherapy in Inflammatory Bowel Disease". This study aims to determine if there is any difference in the efficacy of Inflammatory Bowel Disease (IBD) medication and disease outcomes when taken in the morning or in the evening. The IBD medications being observed are azathioprine and 6-mercaptopurine. The study team believes that there may be...
What is the current status of trial NCT04304950?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2016-04-25. Estimated completion is 2023-04.
What interventions are being tested in trial NCT04304950?
The interventions under investigation include: Evening Group (DRUG), Morning Group (DRUG).
Who is sponsoring clinical trial NCT04304950?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04304950's enrollment target sits among peer trials
28 1635th of 2000 higher than 350 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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