Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000347662
Ethics application status
Not yet submitted
Date submitted
24/03/2014
Date registered
1/04/2014
Date last updated
1/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Placebo controlled trial of Metformin for active Ulcerative Colitis
Scientific title
Metformin versus Placebo in Active Ulcerative Colitis for clinical and endoscopic response
Secondary ID [1] 284327 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 291478 0
Condition category
Condition code
Oral and Gastrointestinal 291843 291843 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Metformin 500mg oral twice daily for six weeks. Adherence will be assessed by pill counts.
Intervention code [1] 289044 0
Treatment: Drugs
Comparator / control treatment
Placebo (sugar pill) oral twice daily for six weeks
Control group
Placebo

Outcomes
Primary outcome [1] 291758 0
Tolerability and safety of 6 weeks of therapy with metformin 500mg oral twice daily in patients with mild to moderate ulcerative colitis. Stool frequency, blood glucose and lactic acidosis shall be assessed at each visit (weeks 0, 3 and 6). Patients will also be monitored for general well being and adverse events.
Timepoint [1] 291758 0
Assessed at 6 weeks
Secondary outcome [1] 307437 0
Clinical response at 6 weeks defined by the Mayo score (0-12) with a reduction of 3 or more and a relative decrease from baseline of 30% or more with an accompanying decrease in the rectal bleeding sub-score of 1 point or more or an absolute rectal bleeding subscore of 0 or 1
Timepoint [1] 307437 0
Assessed at 6 weeks
Secondary outcome [2] 307540 0
Clinical remission defined as a total Mayo score of 0 to 2, with no individual sub-score exceeding 1.
Timepoint [2] 307540 0
Assessed at 6 weeks

Eligibility
Key inclusion criteria
Adults age 18-60 years
Confirmed diagnosis of ulcerative colitis for greater than 3 months
Mild to moderately active UC (defined by a Mayo score of 4-10) despite a minimum of 4 weeks of therapy with at least 3g daily of oral 5-ASA compound
Endoscopic sub score of greater than or equal to 1
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Renal impairment (eGFR < 60)
Lactic acidosis
Sensitivity or previous intolerance to metformin
Pregnant or breast feeding
Evidence of infectious colitis on basis of stool culture
Poorly controlled T2DM (HbA1c > 8.0%)
Inability to provide informed consent
Contraindication to flexible sigmoidoscopy
New York Heart Association Class III or IV heart failure
Active malignancy other than non-melanoma skin cancer in the last 5 years.
Taking interacting drugs: vit K antagonists; cimetidine; nifedipine; beta blockers; alcohol; iodinated contrast materials
Liver disease

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
This is a pilot study designed to assess the safety and tolerability of metformin. As such, it is not specifically powered to assess efficacy. However, assuming a clinically meaningful response to metformin therapy with a 3 point reduction in the Mayo score compared to a 1 point reduction in the placebo group, assuming a standard deviation in both groups of 1, a power of 80% and confidence interval of 95% recruitment of 20 patients in the active arm and 10 in the placebo arm is adequately powered to detect if there is a meaningful clinical response to metformin treatment in UC.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/05/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288963 0
Self funded/Unfunded
Name [1] 288963 0
Country [1] 288963 0
Primary sponsor type
Individual
Name
Gregory Moore
Address
Monash Medical Centre
246 Clayton Rd, Clayton, Victoria 3168
Australia
Country
Australia
Secondary sponsor category [1] 287644 0
None
Name [1] 287644 0
Address [1] 287644 0
Country [1] 287644 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290773 0
Monash Health Research Directorate
Ethics committee address [1] 290773 0
Monash Health
Clayton Rd
Clayton, Victoria 3168
Ethics committee country [1] 290773 0
Australia
Date submitted for ethics approval [1] 290773 0
09/04/2014
Approval date [1] 290773 0
Ethics approval number [1] 290773 0

Summary
Brief summary
This project aims to assess the safety of Metformin and how well it works in patients with active Ulcerative Colitis. Metformin is approved in Australia to treat Type 2 Diabetes and has been used for over 50 years.
In addition its effect on blood glucose metformin has more recently been shown to have anti-inflammatory effects, which are important in the activity and severity of ulcerative colitis. Metformin may have a therapeutic benefit in ulcerative colitis via this anti-inflammatory effect.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47226 0
Dr Gregory Moore
Address 47226 0
Department of Gastroenterology,
Monash Medical Centre
246 Clayton Rd, Clayton, Victoria 3168
Country 47226 0
Australia
Phone 47226 0
+613 95946666
Fax 47226 0
Email 47226 0
[email protected]
Contact person for public queries
Name 47227 0
Dr Edward Shelton
Address 47227 0
Department of Gastroenterology,
Monash Medical Centre
246 Clayton Rd, Clayton, Victoria 3168
Country 47227 0
Australia
Phone 47227 0
+613 95946666
Fax 47227 0
Email 47227 0
[email protected]
Contact person for scientific queries
Name 47228 0
Dr Edward Shelton
Address 47228 0
Department of Gastroenterology,
Monash Medical Centre
246 Clayton Rd, Clayton, Victoria 3168
Country 47228 0
Australia
Phone 47228 0
+613 95946666
Fax 47228 0
Email 47228 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.