Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis
Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
Summary
Ulcerative Colitis (UC) is a life-long incurable disease with remissions and exacerbations.
Inflammation confined to the rectum occurs in a quarter of patients and can be extremely hard
to treat. Many medications have been tried in order to control the inflammation, but they do
not always work. One of the newer medications is the immunosuppressing medication, tacrolimus
that has been shown to be effective in UC when taken orally. Unfortunately, the oral use of
this medication can have numerous serious side effects. In order to overcome these side
effects, the use of topical rectal tacrolimus has been examined. Pilot studies in ulcerative
proctitis (inflammation confined to the rectum) resistant to conventional therapies have
demonstrated a clinical remission in 75% of patients and although the medication was well
absorbed through the lining of the bowel, the levels in the blood were very low and no
serious side effects were reported. The findings suggest that this preparation is indeed
effective for inflammation in the distal bowel and that the method of administration reduces
side effects. Further work, however, now needs to be undertaken to validate the original
findings.
Phase:
Phase 4
Details
Lead Sponsor:
The University of Western Australia
Collaborators:
Fremantle Hospital and Health Service Liverpool Hospital, Australia Royal Adelaide Hospital, Australia Royal Brisbane and Women's Hospital