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Trial registered on ANZCTR


Trial ID
ACTRN12615000150549
Ethics application status
Approved
Date submitted
12/08/2014
Date registered
17/02/2015
Date last updated
17/02/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Budesonide in patients with functional dyspepsia.
Scientific title
A randomised placebo controlled, double blind study to evaluate the effectiveness of Budesonide in reducing symptoms in patients with functional dyspepsia
Secondary ID [1] 285155 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Dyspepsia 292745 0
Condition category
Condition code
Oral and Gastrointestinal 293037 293037 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
Budesonide
a) 9mg (1 effervescent tablet contains 3 mg budesonide/ taken 3 times daily)
b). Duration - 8 weeks
c) Dissolve EACH tablet in 50 mL of water and wait for tablet to finish effervescing. Then mix in with apple sauce and take 1 hour before meals.
d). Tablet return is the strategy used to monitor adherence.
Intervention code [1] 290003 0
Treatment: Drugs
Comparator / control treatment
Placebo -effervescent tablet
Control group
Placebo

Outcomes
Primary outcome [1] 292900 0
Symptom reduction during the objective nutrient challenge test (participants will be asked to drink 200 ml of a liquid meal consisting of 3.8 g protein, 13.8 g carbohydrate, 3.4 g fat/100 ml every five minutes and report symptoms after a total of 600 ml). The questionnaire will ask about fullness, nausea, bloating and pain using a 100mm VAS scale from unnoticeable to unbearable.

Timepoint [1] 292900 0
End of treatment (8 weeks)
Primary outcome [2] 292901 0
Histological eosinophil quantitation and immunopathological evaluation
Timepoint [2] 292901 0
End of treatment (8 weeks)
Secondary outcome [1] 309894 0
Quality of life: Nepean Dyspepsia Index
Timepoint [1] 309894 0
End of treatment (8 weeks),1 month Follow-up (12 weeks)
Secondary outcome [2] 309895 0
Psychological distress (anxiety and depression): validated Hospital Anxiety and Depression Scale
Timepoint [2] 309895 0
End of treatment (8 weeks), 1 month Follow-up (12 weeks)
Secondary outcome [3] 309896 0
Diary - abdominal symptom intensity: Mechanical Visual Analogue Scale (M-VAS)
Timepoint [3] 309896 0
End of treatment (8 weeks)
Secondary outcome [4] 309897 0
Th2 T cell responses in the duodenum (qPCR and explant culture).
Timepoint [4] 309897 0
End of treatment (8 weeks)

Eligibility
Key inclusion criteria
Functional Dyspepsia patients with duodenal eosinophilia
Minimum age
18 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with type I diabetes, immunosuppression, active infection, TB, peptic ulcer, liver or renal disease, or osteoporosis.

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)
Subjects qualifying for the study (n= 70) will be randomized to one of two treatment arms using random blocks by computer. Concealed allocation will be assured by central allocation through the JHH, PAH, Nepean Hospital and Gosford Hospital pharmacies. Recruited patients will undergo a washout period of 2 weeks and eligible patients will attend an appointment at the outpatient clinic to formally consent to the study, complete baseline assessments and collect medication.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random blocks by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
A randomized, double-blind, placebo-controlled trial, with a 2 arm design, consisting of 3 phases: a 2-week drug free screening phase, an 8-week, identical placebo treatment phase, and a post treatment follow up phase over 4 weeks.
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical analysis plan: Randomized groups will be compared in terms of potentially confounding variables. If any baseline differences between groups are found that may affect the outcome variables these will be included as covariates in a covariance model including group and covariate terms. If the assumption of normality is not met formal inference will employ the nonparametric bootstrap. A sample of n=32 per study group will provide statistical power >0.9 at the 0.01 (two-tailed) level of statistical significance if the improvement in mean eosinophil count is 50% from a base of mean 33, SD=19 among treated individuals but only 15% among controls. N=32 per group will also provide statistical power of 0.9 at the 0.01 level of statistical significance for a Cohen d effect size of 1.0 for comparisons of symptom reduction.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 2835 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [2] 2836 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 2837 0
Nepean Hospital - Kingswood
Recruitment hospital [4] 2838 0
Gosford Hospital - Gosford
Recruitment postcode(s) [1] 8525 0
2305 - New Lambton
Recruitment postcode(s) [2] 8526 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 8527 0
2747 - Kingswood
Recruitment postcode(s) [4] 8528 0
2250 - Gosford

Funding & Sponsors
Funding source category [1] 289756 0
University
Name [1] 289756 0
University of Newcastle
Address [1] 289756 0
University of Newcastle
University Drive
Callaghan NSW 2308
Country [1] 289756 0
Australia
Funding source category [2] 290733 0
Commercial sector/Industry
Name [2] 290733 0
Falk Pharmaceuticals
Address [2] 290733 0
Falk Foundation e.V.
Leinenweberstr. 5
D-79108 Freiburg
Postbox 6529
D-79041 Freiburg
Germany
Country [2] 290733 0
Germany
Primary sponsor type
University
Name
University of Newcastle
Address
University of Newcastle
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 289074 0
None
Name [1] 289074 0
Address [1] 289074 0
Country [1] 289074 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291490 0
Hunter New England Health Human Research Ethics Committee
Ethics committee address [1] 291490 0
Hunter New England Research Ethics & Governance Unit
Locked Bag 1
New Lambton NSW 2305
Ethics committee country [1] 291490 0
Australia
Date submitted for ethics approval [1] 291490 0
Approval date [1] 291490 0
23/06/2014
Ethics approval number [1] 291490 0
13/12/11/3.01

Summary
Brief summary
Functional dyspepsia affects a considerable proportion of Australians and results in significant personal and economic cost. There is as yet no cure for this condition and current treatments are generally not effective for the majority of people with functional dyspepsia.

New research into the causes of functional dyspepsia have found that the numbers of a type of immune cell, the eosinophil, are increased in the top of the small bowel in patients with dyspepsia.

A treatment called Budesonide has been shown to lower the amount of the eosinophils in the top of the small bowel. Budesonide is already an effective treatment in the management of other diseases including coeliac disease, collagenous sprue, oesophagitis and bronchitis. It is suspected that Budesonide will also be a promising treatment for functional dyspepsia but this needs to be properly tested.

In this study we aim to test the effectiveness of Budesonide in people with functional dyspepsia in a randomised placebo controlled, double blind study.
Trial website
None available
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 50646 0
Prof Nicholas Talley
Address 50646 0
HMRI Building
University of Newcastle
Lookout Rd
New Lambton NSW 2305
Country 50646 0
Australia
Phone 50646 0
+61 2 4921 5885
Fax 50646 0
Email 50646 0
Nicholas.Talley@newcastle.edu.au
Contact person for public queries
Name 50647 0
Dr Natasha Koloski
Address 50647 0
HMRI Building
University of Newcastle
Lookout Rd
New Lambton NSW 2305
Country 50647 0
Australia
Phone 50647 0
61407126897
Fax 50647 0
Email 50647 0
Natasha.Koloski@newcastle.edu.au
Contact person for scientific queries
Name 50648 0
Dr Natasha Koloski
Address 50648 0
HMRI Building
University of Newcastle
Lookout Rd
New Lambton NSW 2305
Country 50648 0
Australia
Phone 50648 0
+61 407126897
Fax 50648 0
Email 50648 0
Natasha.Koloski@newcastle.edu.au