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Immunosuppressant
Morning for Inflammatory Bowel Disease
Phase 4
Waitlist Available
Led By Garth Swanson, MD
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks post baseline visit.
Awards & highlights
Study Summary
This trial is studying whether it's better to take azathioprine or 6-mercaptopurine in the morning or evening for people with inflammatory bowel disease.
Eligible Conditions
- Inflammatory Bowel Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks post baseline visit.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks post baseline visit.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6-Methylmercaptopurine Levels in Blood
Harvey Bradshaw Activity Index
Short Inflammatory Bowel Disease Questionnaire
+1 moreSecondary outcome measures
Munich Chronotype Questionnaire ( MCTQ)
Trial Design
2Treatment groups
Experimental Treatment
Group I: MorningExperimental Treatment1 Intervention
Participants with Ulcerative Colitis or Crohn's Disease taking 6-Mercatopurine or Azathioprine orally once a day in the evening were assigned to the morning group. Instead of taking their medication at their usual PM time, they were instructed to take their medications in the morning for the duration of the study-10 weeks. The dosage amount is per clinical care and not defined by the study protocol.
Group II: EveningExperimental Treatment1 Intervention
Participants with Ulcerative Colitis or Crohn's Disease taking 6-Mercatopurine or Azathioprine orally once a day in the morning were assigned to the evening group. Instead of taking their medication at their usual AM time, they were instructed to take their medications in the evening for the duration of the study-10 weeks. The dosage amount is per clinical care and not defined by the study protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Evening Group
2016
Completed Phase 4
~30
Morning Group
2016
Completed Phase 4
~30
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Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
422 Previous Clinical Trials
163,503 Total Patients Enrolled
Garth Swanson, MDPrincipal Investigator - Rush University Medical Center
Rush University Medical Center
Medical University Of South Carolina College Of Medicine (Medical School)
Rush-Presby-St Luke'S M C (Residency)
1 Previous Clinical Trials
52 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can you provide insight into the safety of utilizing Azathiopurine to treat Crohn's Disease?
"Our team has evaluated the safety of Azathiopurine for Crohn's disease to be a score of 3 due to its approval in Phase 4 clinical trials."
Answered by AI
Is there currently an opportunity for enrolment in this research?
"As stated on clinicaltrials.gov, this research trial is not currently taking part in participant recruitment. The study was initially posted on April 25th 2016 and its most recent update occurred September 22nd 2022. Although this project does not need any more participants, there are 198 other studies that require enrolment at the moment."
Answered by AI
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