Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis (NCT01418131) | Clinical Trial Compass
CompletedPhase 4
Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis
Australia21 participantsStarted 2012-10
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Is able to provide informed consent.
✓. Is over the age of 18 years
✓. Has a diagnosis of ulcerative colitis of over 3 months duration that was confirmed by a specialist gastroenterologist
✓. Has inflammation limited to 25cm proximal to the anal verge
✓. Has failed to achieve remission with, or be intolerant of, the use of conventional therapy defined as oral and/or rectal 5-Aminosalicylates, and/or oral and rectal steroids
✓. Has symptoms of active UC with a Mayo score of between 6 and12
✓. Medications:
✓. Oral 5-Aminosalicylates: If taking an oral 5-Aminosalicylates the patient has used them continuously for 4 weeks and has been on a stable dose for 2 weeks prior to the screening visit.