Trial intelligence / Profile preview

Chronotherapy in Inflammatory Bowel Disease

NCT04304950Phase 4

Key facts

Status: Completed
Start: Apr 2016
Primary completion: Dec 2021
Countries: 1
Sponsor: Rush University Medical Center
Modality: Small Molecules

Drugs: azathioprinemercaptopurine
Conditions: Crohn's disease (CD)ulcerative colitis (UC)

Overview

Phase 4, open-label trial of azathioprine and mercaptopurine in Crohn's disease (CD) and ulcerative colitis (UC) (2 arms), sponsored by Rush University Medical Center. Primary endpoints: Thioguanine Levels in Blood at 10 weeks, Harvey Bradshaw Activity Index at 10 weeks and 2 more. Started Apr 2016; status: completed.

Design

2 arms

Study design: Non-randomizedOpen-label

Morning Group
Participants switched from evening to morning dosing (6am-11am).
Evening Group
Participants switched from morning to evening dosing (6pm-11pm).

Who it enrols

Adult patients with Crohn's Disease or Ulcerative Colitis currently taking azathioprine or 6-mercaptopurine.

Endpoints

Primary

Thioguanine Levels in Blood10 weeks
Harvey Bradshaw Activity Index10 weeks
Short Inflammatory Bowel Disease Questionnaire10 weeks
6-Methylmercaptopurine Levels in Blood10 weeks

Secondary

Munich Chronotype Questionnaire10 weeks

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