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Trial registered on ANZCTR


Registration number
ACTRN12609000738224
Ethics application status
Approved
Date submitted
21/08/2009
Date registered
25/08/2009
Date last updated
16/06/2021
Date data sharing statement initially provided
16/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised, double blind, placebo-controlled trial evaluating the effectivenes and safety of oral budesonide in healing the small bowel in patients with newly diagnosed coeliac disease
Scientific title
A phase II, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of oral effervescent budesonide in the induction of mucosal healing in newly diagnosed coeliac disease.
Secondary ID [1] 252816 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Newly diagnosed coeliac disease 243570 0
Condition category
Condition code
Oral and Gastrointestinal 239866 239866 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gluten free diet (prescribed by an Accredited Practising Dietitian and with compliance assessed regularly throughout the study) PLUS oral effervescent budesonide 3mg three times per day for 8 weeks, followed by 3mg twice daily for 1 week, followed by 3mg daily for 1 week
Intervention code [1] 241172 0
Treatment: Drugs
Comparator / control treatment
Gluten free diet as above PLUS placebo (effervescent sugar tablets of identical taste and form) in identical unit dosing and timescale
Control group
Placebo

Outcomes
Primary outcome [1] 240652 0
Proportion of patients achieving mucosal healing (as defined by modern histological classification - Marsh I or better)
Timepoint [1] 240652 0
8 weeks from randomisation
Secondary outcome [1] 257288 0
Proportion of patients achieving mucosal healing defined by Marsh 0
Timepoint [1] 257288 0
8 weeks and 12 months from randomisation
Secondary outcome [2] 257289 0
Proportion of patients achieving mucosal healing (Marsh I or better)
Timepoint [2] 257289 0
12 months from randomisation
Secondary outcome [3] 257290 0
Proportion of patients healing (Marsh I or better) who have a full or half dose of Human Leukocyte Antigen (HLA-DQ2)
Timepoint [3] 257290 0
8 weeks and 12 months from randomisation
Secondary outcome [4] 257291 0
Degree of symptom improvement as determined by a visual analogue scale (VAS) assessing key gastrointestinal symptoms and administered regularly throughout the study.
Timepoint [4] 257291 0
At 8 weeks from randomisation. VAS administered at randomisation and weeks 4 and 8.
Secondary outcome [5] 257292 0
Change in Bone Mineral Density from baseline as assessed by Dual energy x-ray absorptiometry (DEXA) performed at the hip and lumbar spine.
Timepoint [5] 257292 0
12 months from randomisation.
Secondary outcome [6] 257293 0
Change in fatigue and measures of anxiety and depression as assessed by validated questionnaires - Hospital anxiety and depression score (HADS) and the Fatigue Impact Scale (FIS)
Timepoint [6] 257293 0
8 weeks, 6 months and 12 months from randomisation
Secondary outcome [7] 263706 0
Degree of improvement in villous height to crypt depth ratio.
Timepoint [7] 263706 0
8 weeks and 12 months from randomisation

Eligibility
Key inclusion criteria
Newly disgnosed coeliac disease
Marsh III or greater on duodenal histology
Minimum age
16 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Gluten free diet for more than 4 weeks Marsh I-II on duodenal histology Significant comorbidities (heart failure, diabetes, untreated thyroid disease, inflammatory bowel disease) Existing or intended pregnancy Use of inhaled steroids Abnormal liver function tests

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)
Patients will be given a consecutive number in the order of enrolment in the study. This number serves as a unique identifier of the study oatient throughout the study. Concealment of allocation will be achieved by central randomisation by a computer off-site from the location of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The consecutive number (unique identifier) will be allocated at random by means of a computer-generated randomisation list. Randomisation will be performed using randomly permuted blocks.
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 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/04/2010
Actual
7/04/2010
Date of last participant enrolment
Anticipated
Actual
19/03/2014
Date of last data collection
Anticipated
Actual
19/03/2015
Sample size
Target
40
Accrual to date
Final
37
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19744 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 34385 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 237533 0
Commercial sector/Industry
Name [1] 237533 0
Dr Falk Pharma
Country [1] 237533 0
Germany
Primary sponsor type
University
Name
Eastern Clinical Research Unit
Address
Level 2, 5 Arnold Street
Box Hill, Victoria 3128
Country
Australia
Secondary sponsor category [1] 237009 0
Hospital
Name [1] 237009 0
Box Hill Hospital
Address [1] 237009 0
Nelson Road
Box Hill
Victoria 3128
Country [1] 237009 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243664 0
Ethics committee address [1] 243664 0
Ethics committee country [1] 243664 0
Date submitted for ethics approval [1] 243664 0
24/08/2009
Approval date [1] 243664 0
Ethics approval number [1] 243664 0
TBA
Ethics committee name [2] 258734 0
Eastern Health Research and Ethics Committee
Ethics committee address [2] 258734 0
Level 3, 5 Arnold Street
Box Hill, Victoria 3128
Ethics committee country [2] 258734 0
Australia
Date submitted for ethics approval [2] 258734 0
26/08/2009
Approval date [2] 258734 0
06/11/2009
Ethics approval number [2] 258734 0
E22-0910

Summary
Brief summary
Coeliac disease is a condition which affects 1% of the Australian population and is an abnormal immune response to ingested gluten resulting in damage to the small bowel. The aim of treatment is to heal the small bowel and thus avoid long term complications. Despite adherance to a strict gluten free diet, up to 1 in 3 people fail to achieve this healing. The purpose of this study is to examine the effectiveness and safety of budesonide, a corticosteroid medication, in inducing faster and more complete healing of the small bowel than the gluten free diet alone in patients with newly diagnosed coeliac disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30082 0
Prof Peter Gibson
Address 30082 0
Department of Gastroenterology
The Alfred Hospital
Commercial Road
Prahran
Country 30082 0
Australia
Phone 30082 0
+61 3 9094 9555
Fax 30082 0
Email 30082 0
[email protected]
Contact person for public queries
Name 13329 0
Evan Newnham
Address 13329 0
Department of Gastroenterology
Box Hill Hospital
Neslon Road
Box Hill
VICTORIA 3128
Country 13329 0
Australia
Phone 13329 0
+61 3 9094 9534
Fax 13329 0
+61 3 9899 9137
Email 13329 0
[email protected]
Contact person for scientific queries
Name 4257 0
Professor Peter Gibson
Address 4257 0
Department of Medicine
Box Hill Hospital
Neslon Road
Box Hill
VICTORIA 3128
Country 4257 0
Australia
Phone 4257 0
+61 3 9094 9575
Fax 4257 0
+61 3 9899 9137
Email 4257 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This was not part of the initial ethics submission and will thus require an amendment.


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
SourceTitleYear of PublicationDOI
EmbaseRandomised clinical trial: adjunctive induction therapy with oral effervescent budesonide in newly diagnosed coeliac disease.2021https://dx.doi.org/10.1111/apt.16446
N.B. These documents automatically identified may not have been verified by the study sponsor.