JPRN‐UMIN000007406.
Methods |
Study design: randomised, parallel group trial Setting: Jichi Medical University hospital for induction of remission Study period: 1 April 2012 to NR |
Participants |
Inclusion criteria: adults aged 20–75 years; moderate‐to‐severe active UC; people with comorbidities should be stable and no alterations to their therapeutic regimen are expected; able to understand and sign an informed consent Exclusion criteria: hypersensitivity or contraindication to tacrolimus; unable to make an informed consent due to any disorder such as dementia 20 participants Disease activity: NR Disease duration: NR Extent of disease: NR Age: NR Sex (M/F): NR Concurrent therapies: NR Number enrolled: NR Number randomised: NR Number reaching end of study: NR |
Interventions |
IG: conventional steroid tapering (5 mg/day every 2 weeks) CG: rapidly tapering dose of steroids |
Outcomes |
Primary outcome: Mayo score Secondary outcome: Stool frequency, rectal bleeding, Matts Score, C‐reactive protein Duration: NR Length of intervention and follow‐up points: NR Definition of remission or clinical improvement by study authors: NR Number of participants who achieved remission: NR Number of participants who achieved clinical improvement: NR Time to onset of action for tacrolimus from beginning of study: NR Number of participants who required other rescue medication: NR Time to other rescue medication from beginning of study: NR Number of participants who underwent surgery: NR Time to surgery from beginning of study: NR Adverse events: NR Withdrawal due to adverse events: NR Serious adverse events: NR Time to adverse events from beginning of study: NR |
Notes | Contacted author by email on 23 November 2020 for further information; the email was undeliverable. |