ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Newly diagnosed coeliac disease

Condition category

Condition code

Oral and Gastrointestinal

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]

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]

Proportion of patients achieving mucosal healing (as defined by modern histological classification - Marsh I or better)

Timepoint [1]

8 weeks from randomisation

Secondary outcome [1]

Proportion of patients achieving mucosal healing defined by Marsh 0

Timepoint [1]

8 weeks and 12 months from randomisation

Secondary outcome [2]

Proportion of patients achieving mucosal healing (Marsh I or better)

Timepoint [2]

12 months from randomisation

Secondary outcome [3]

Proportion of patients healing (Marsh I or better) who have a full or half dose of Human Leukocyte Antigen (HLA-DQ2)

Timepoint [3]

8 weeks and 12 months from randomisation

Secondary outcome [4]

Degree of symptom improvement as determined by a visual analogue scale (VAS) assessing key gastrointestinal symptoms and administered regularly throughout the study.

Timepoint [4]

At 8 weeks from randomisation. VAS administered at randomisation and weeks 4 and 8.

Secondary outcome [5]

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]

12 months from randomisation.

Secondary outcome [6]

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]

8 weeks, 6 months and 12 months from randomisation

Secondary outcome [7]

Degree of improvement in villous height to crypt depth ratio.

Timepoint [7]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Box Hill Hospital - Box Hill

Recruitment postcode(s) [1]

3128 - Box Hill

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Dr Falk Pharma

Address [1]

Leinenweberstr. 5
D-79108 Freiburg
Postbox 6529
D-79041 Freiburg

Country [1]

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]

Hospital

Name [1]

Box Hill Hospital

Address [1]

Nelson Road
Box Hill
Victoria 3128

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics committee address [1]

Ethics committee country [1]

Date submitted for ethics approval [1]

24/08/2009

Approval date [1]

Ethics approval number [1]

TBA

Ethics committee name [2]

Eastern Health Research and Ethics Committee

Ethics committee address [2]

Level 3, 5 Arnold Street
Box Hill, Victoria 3128

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

26/08/2009

Approval date [2]

06/11/2009

Ethics approval number [2]

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

Prof Peter Gibson

Address

Department of Gastroenterology
The Alfred Hospital
Commercial Road
Prahran

Country

Australia

Phone

+61 3 9094 9555

Fax

peter.gibson@monash.edu

Contact person for public queries

Name

Evan Newnham

Address

Department of Gastroenterology
Box Hill Hospital
Neslon Road
Box Hill
VICTORIA 3128

Country

Australia

Phone

+61 3 9094 9534

Fax

+61 3 9899 9137

evan.newnham@monash.edu

Contact person for scientific queries

Name

Professor Peter Gibson

Address

Department of Medicine
Box Hill Hospital
Neslon Road
Box Hill
VICTORIA 3128

Country

Australia

Phone

+61 3 9094 9575

Fax

+61 3 9899 9137

peter.gibson@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Randomised clinical trial: adjunctive induction therapy with oral effervescent budesonide in newly diagnosed coeliac disease.	2021	https://dx.doi.org/10.1111/apt.16446

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically