CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 28 enrolled
Drug / intervention
Evening Group +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04304950
NCT04304950Phase 4Completed

Chronotherapy in Inflammatory Bowel Disease

Rush University Medical Center·interventional·Posted Mar 12, 2020·Updated Jun 27, 2023

In Brief

A Phase 4 clinical trial evaluating Evening Group and Morning Group for Inflammatory Bowel Diseases. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 12, 2020
Enrollment StartApr 25, 2016
Primary CompletionDec 1, 2021
Study CompletionApr 1, 2023
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 6.3 years ago

Interventions

Evening Groupdrug

Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm.

Morning Groupdrug

Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am.