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Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis

NCT01418131 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2016-12-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Rectal tacrolimus

Rectal tacrolimus made as an ointment at a concentration of 0.5mg/ml with 3 mls will be applied rectally twice a day

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Royal Brisbane and Women's Hospital

    collaborator OTHER_GOV

  • Royal Adelaide Hospital, Australia

    collaborator UNKNOWN

  • Liverpool Hospital, Australia

    collaborator UNKNOWN

  • Fremantle Hospital and Health Service

    collaborator OTHER

  • The University of Western Australia

    lead OTHER

Principal Investigators

  • Ian C Lawrance, MBBS PhD · University of Western Australia, Fremantle Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2016-09-30
Completion
2016-11-30

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01418131 on ClinicalTrials.gov