Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01418131




Registration number
NCT01418131
Ethics application status
Date submitted
15/08/2011
Date registered
16/08/2011
Date last updated
15/12/2016

Titles & IDs
Public title
Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis
Scientific title
A Multi-centre Double Blind Randomised Placebo-controlled Study of the Use of Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis
Secondary ID [1] 0 0
Tacro001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rectal tacrolimus
Treatment: Drugs - Placebo

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

Placebo comparator: Rectal Placebo - Placebo 3ml applied rectally twice a day. Identical to Interventional agent expect for the lack of tacrolimus


Treatment: Drugs: 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

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical response
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Remission rates
Timepoint [1] 0 0
8 weeks
Secondary outcome [2] 0 0
Mucosal Healing
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Changes in the Mayo Score
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Quality of Life
Timepoint [4] 0 0
8 weeks
Secondary outcome [5] 0 0
Safety and tolerability
Timepoint [5] 0 0
8 weeks
Secondary outcome [6] 0 0
Cytokine Expression
Timepoint [6] 0 0
8 weeks

Eligibility
Key inclusion criteria
1. Is able to provide informed consent.
2. Is over the age of 18 years
3. Has a diagnosis of ulcerative colitis of over 3 months duration that was confirmed by a specialist gastroenterologist
4. Has inflammation limited to 25cm proximal to the anal verge
5. 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
6. Has symptoms of active UC with a Mayo score of between 6 and12
7. Medications:

1. 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.
2. 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.
3. 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.
4. Rectal Preparations; 5-Aminosalicylates and corticosteroids: All rectal preparations have been ceased at least one day prior to Week 0.
8. Has a normal serum potassium levels defined as 3.4-5mmol/L.
9. Has normal renal function defined as a Glomerular Filtration Rate (GFR) >60ml/min.
10. Willing to participate in the study and comply with the proceedings by signing a written informed consent.
11. Free of any clinically significant disease, other than ulcerative colitis, that would interfere with the study's evaluations.
12. 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Has Crohn's disease.
2. Has colitis extending more than 25cm from the anal verge.
3. Has a known hypersensitivity/allergic reaction to tacrolimus.
4. Is pregnant or is breast-feeding.
5. Has unstable, or poorly controlled, hypertension.
6. Has an abnormal serum potassium level defined as outside the range of 3.4-5mmol/L.
7. Has chronic renal failure defined as a Glomerular Filtration Rate <60 ml/min.
8. Is currently using a potassium-sparing diuretic agent.
9. Has received a trial medication within 12 weeks of screening.
10. Has documented HIV infection.
11. 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).
12. Presence of alcoholism, alcoholic liver disease, or other chronic liver disease.
13. Has known dementia and the inability to understand the trial requirements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2016
Sample size
Target
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Centre for IBD, Fremantle Hospital - Fremantle
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
6160 - Fremantle

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Western Australia
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Royal Brisbane and Women's Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Royal Adelaide Hospital, Australia
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Liverpool Hospital, Australia
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Fremantle Hospital and Health Service
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ian C Lawrance, MBBS PhD
Address 0 0
University of Western Australia, Fremantle Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01418131