Status:
COMPLETED
Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis
Lead Sponsor:
The University of Western Australia
Collaborating Sponsors:
Royal Brisbane and Women's Hospital
Royal Adelaide Hospital, Australia
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Detailed Description
The Inflammatory Bowel Diseases (IBDs) are life-long conditions often diagnosed between 15 and 35 years of age that are increasing in frequency. In developed countries, IBD prevalence was about 100-22...
Eligibility Criteria
Inclusion
- 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.
- Oral Corticosteroids: If taking oral corticosteroids the patient has used them continuously for 4 weeks and has been on a stable dose for 2 weeks prior to the screening visit at a dose of ≤30mg.
- Oral Azathioprine/6MP or Methotrexate: If taking one of these medications the patient has used them for a minimum of 12 weeks and has been on a stable dose for 4 weeks prior to screening.
- Rectal Preparations; 5-Aminosalicylates and corticosteroids: All rectal preparations have been ceased at least one day prior to Week 0.
- Has a normal serum potassium levels defined as 3.4-5mmol/L.
- Has normal renal function defined as a Glomerular Filtration Rate (GFR) \>60ml/min.
- Willing to participate in the study and comply with the proceedings by signing a written informed consent.
- Free of any clinically significant disease, other than ulcerative colitis, that would interfere with the study's evaluations.
- Subjects can understand and is able to adhere to the dosing and visit schedules; Agrees to record symptom severity scores, medication times, adverse events and concomitant medications accurately and consistently.
Exclusion
- Has Crohn's disease.
- Has colitis extending more than 25cm from the anal verge.
- Has a known hypersensitivity/allergic reaction to tacrolimus.
- Is pregnant or is breast-feeding.
- Has unstable, or poorly controlled, hypertension.
- Has an abnormal serum potassium level defined as outside the range of 3.4-5mmol/L.
- Has chronic renal failure defined as a Glomerular Filtration Rate \<60 ml/min.
- Is currently using a potassium-sparing diuretic agent.
- Has received a trial medication within 12 weeks of screening.
- Has documented HIV infection.
- Has a known malignancy, a pre-malignant lesion, or any history of malignancy within the past 5 years (excluding squamous and/or basal cell carcinomas).
- Presence of alcoholism, alcoholic liver disease, or other chronic liver disease.
- Has known dementia and the inability to understand the trial requirements.
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01418131
Start Date
October 1 2012
End Date
November 1 2016
Last Update
December 15 2016
Active Locations (4)
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1
Liverpool Hospital
Sydney, New South Wales, Australia
2
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
3
Royal Adelaide Hospital
Adelaide, South Australia, Australia
4
Centre for IBD, Fremantle Hospital
Fremantle, Western Australia, Australia, 6160