Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01418131 |
Recruitment Status :
Completed
First Posted : August 16, 2011
Last Update Posted : December 15, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ulcerative Colitis | Drug: Rectal tacrolimus Drug: Placebo | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Multi-centre Double Blind Randomised Placebo-controlled Study of the Use of Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | September 2016 |
Actual Study Completion Date : | November 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Rectal tacrolimus
Active medications - Rectal tacrolimus made as an ointment at a concentration of 0.5mg/ml 3mls will be applied rectally twice a day
|
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
Other Name: calcineurin inhibitor |
Placebo Comparator: Rectal Placebo
Placebo 3ml applied rectally twice a day. Identical to Interventional agent expect for the lack of tacrolimus
|
Drug: Placebo
Placebo
Other Name: Control Arm |
- Clinical response [ Time Frame: 8 weeks ]Clinical response (Mayo Score) of resistant ulcerative proctitis after 8 weeks of rectal tacrolimus therapy
- Remission rates [ Time Frame: 8 weeks ]Remission rates (Mayo Score) of resistant ulcerative proctitis after 8 weeks of rectal tacrolimus
- Mucosal Healing [ Time Frame: 8 weeks ]Effect of rectal tacrolimus on mucosal healing after 8 weeks of therapy
- Changes in the Mayo Score [ Time Frame: 8 weeks ]Changes in the modified Mayo Score between tacrolimus and control groups over 8 weeks of therapy
- Quality of Life [ Time Frame: 8 weeks ]Changes in quality of life by the Inflammatory Bowel Disease Questionnaire (IBDQ) between tacrolimus and control groups over 8 weeks of therapy
- Safety and tolerability [ Time Frame: 8 weeks ]Safety and tolerability of rectal tacrolimus over 8 weeks of therapy
- Cytokine Expression [ Time Frame: 8 weeks ]Changes in cytokine expression in mucosal biopsies following rectal tacrolimus therapy

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
- 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 Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01418131
Australia, New South Wales | |
Liverpool Hospital | |
Sydney, New South Wales, Australia | |
Australia, Queensland | |
Royal Brisbane and Women's Hospital | |
Brisbane, Queensland, Australia | |
Australia, South Australia | |
Royal Adelaide Hospital | |
Adelaide, South Australia, Australia | |
Australia, Western Australia | |
Centre for IBD, Fremantle Hospital | |
Fremantle, Western Australia, Australia, 6160 |
Principal Investigator: | Ian C Lawrance, MBBS PhD | University of Western Australia, Fremantle Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Ian Lawrance, Professor, The University of Western Australia |
ClinicalTrials.gov Identifier: | NCT01418131 |
Other Study ID Numbers: |
Tacro001 |
First Posted: | August 16, 2011 Key Record Dates |
Last Update Posted: | December 15, 2016 |
Last Verified: | December 2016 |
Proctitis resistant ulcerative colitis inflammatory bowel disease |
Colitis Colitis, Ulcerative Proctitis Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes |
Inflammatory Bowel Diseases Rectal Diseases Tacrolimus Calcineurin Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |