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Trial registered on ANZCTR


Registration number
ACTRN12623000604606
Ethics application status
Approved
Date submitted
11/02/2023
Date registered
2/06/2023
Date last updated
23/06/2024
Date data sharing statement initially provided
2/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized head-to-head trial of proton pump inhibitor (PPI) vs topical corticosteroids (TCs) post food bolus impaction and/or for untreated patients with Eosinophilic esophagitis (EoE).
Scientific title
Randomized head-to-head trial of proton pump inhibitor (PPI) vs topical corticosteroids (TCs) post food bolus impaction and/or for untreated patients with Eosinophilic esophagitis (EoE).
Secondary ID [1] 308138 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eosinophilic oesophagitis (EoE) 327857 0
Condition category
Condition code
Oral and Gastrointestinal 324938 324938 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
Randomisation assessment will occur as baseline visit. The treatment commences 48 hours after randomization day.
Pantoprazole 40mg oral tablet twice per day for 8 weeks, followed by a possible extension period of another 8 weeks. Following 8 weeks of treatment, participants will be reviewed by their treating gastroenterologist (with the first biopsy results). If the severity of their condition has not improved at 8 weeks (determined by >15 eosinophils per high power field [HPF]), participants will be switched to the other arm (Jorveza). The switching process is following study protocol, not participant’s choice. Participant can discontinue trial participation if they wish to.
Intervention code [1] 325039 0
Treatment: Drugs
Comparator / control treatment
Randomisation assessment will occur as baseline visit. The treatment commences 48 hours after randomization day.
Jorvesa 1mg orodispersible tablet twice daily for 8 weeks, followed by a possible extension period of another 8 weeks. Following 8 weeks of treatment, participants will be reviewed by their treating gastroenterologist (with the first biopsy results). If the severity of their condition has not improved at 8 weeks (determined by >15 eosinophils per hpf), participants will be switched to the other arms (PPI). The switching process is following study protocol, not participant’s choice. Participant can discontinue trial participation if they wish to.
Control group
Active

Outcomes
Primary outcome [1] 333343 0
Histology results of eosophageal biopsy demosntrating either <15 or >15 eosinophils per high power field (hpf).
Timepoint [1] 333343 0
8 weeks post randomisation
Primary outcome [2] 334477 0
Histology results of eosophageal biopsy demonstrating either <15 or >15 eosinophils per high power field (hpf).
Timepoint [2] 334477 0
16 weeks post randomisation.
Secondary outcome [1] 416680 0
Change in Endoscopic Reference Score (EREFS; range 0-9).

Timepoint [1] 416680 0
Outcomes will be assessed at baseline (enrolment day), and upon endoscopy at 8 weeks and 16 weeks post randomisation.
Secondary outcome [2] 420882 0
Change in Clinical Symptoms (Symptom-Based Activity Index for Adults with Eosinophilic Esophagitis [EEsAI PRO]).
Timepoint [2] 420882 0
Outcomes will be assessed at baseline (enrolment day), 8 weeks and 16 weeks post randomisation.
Secondary outcome [3] 420883 0
Change in quality of life measured using the Esophageal Hypervigilance and Anxiety Scale.
Timepoint [3] 420883 0
Outcomes will be assessed at baseline (enrolment day), 8 weeks and 16 weeks post randomisation.
Secondary outcome [4] 420884 0
Change in oesophageal wall thickness (ultrasound observation).
Timepoint [4] 420884 0
Outcomes will be assessed at baseline (enrolment day), and upon endoscopy at 8 weeks and 16 weeks post randomisation.
Secondary outcome [5] 420885 0
Change in oesophageal peristalsis at manometry.
Timepoint [5] 420885 0
Outcomes will be assessed at baseline (enrolment day), and upon manometry at week 9 and 17 post randomisation.

Eligibility
Key inclusion criteria
Patients who present with a food bolus obstruction (FBO) or dysphagia.
Diagnosed with EoE, which is defined as eosophageal biopsy containing >15 eosinophils per high power field, in any one oesophageal location (peak count).
On nil current treatment, or willing to cease treatment with PPI or diet for 8 weeks prior to repeat endoscopy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will comprise any of the following conditions or factors:
• Coexistent medical conditions that could cause oesophageal eosinophilia (e.g. primary hypereosinophilic syndrome, organ transplant recipient, connective tissue disorder, Crohn’s disease)
• Medications that could cause oesophageal eosinophilia (e.g. antiepileptic, clozapine)
• Medications that could suppress the immune system and decrease eosinophil count (e.g,systemic corticosteroids, immunosuppressant such as methotrexate or azathioprine, biological agents such as anti – TNF)
• Usual residence is a forensic facility
• Intellectual disability
• Pregnancy

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)
Central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
In this intention to treat analysis, Data will be analyzed using SPSS V21.0 for windows. Continuous data will be considered using the student t – test, whilst categorical variables will be analyzed with the Mann – Whitney or Kruskall – Wallis as appropriate. Statistical significance will be recorded at p<.05 (two tailed).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2023
Actual
20/12/2023
Date of last participant enrolment
Anticipated
1/10/2024
Actual
Date of last data collection
Anticipated
19/02/2025
Actual
Sample size
Target
72
Accrual to date
16
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC

Funding & Sponsors
Funding source category [1] 312402 0
Hospital
Name [1] 312402 0
Northern Adelaide Local Health Network
Country [1] 312402 0
Australia
Primary sponsor type
Hospital
Name
Northern Adelaide Local Health Network
Address
Lyell McEwin Hospital, Haydown Rd, Elizabeth Vale SA 5112
Country
Australia
Secondary sponsor category [1] 313970 0
None
Name [1] 313970 0
Address [1] 313970 0
Country [1] 313970 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311753 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 311753 0
Level 3, Roma Mitchell House 136 North Terrace Adelaide, South Australia, 5000
Ethics committee country [1] 311753 0
Australia
Date submitted for ethics approval [1] 311753 0
13/02/2023
Approval date [1] 311753 0
01/08/2023
Ethics approval number [1] 311753 0
2022/HRE00246

Summary
Brief summary
Eosinophilic oesophagitis (EoE) is a chronic inflammatory condition causing narrowing of the oesophagus manifesting clinically as dysphagia and food bolus impaction (FBO). Two first line medications, namely proton pump inhibitors (PPI’s) and topical corticosteroids (TC’s) are feasible options. we propose an opened label, randomized controlled trial of PPI (Pantoprazole) vs TCs(Jorveza), with a formalized treatment protocol and the ascertainment of symptom scores (questionnaire), endoscopic appearance, histological findings (biopsy), physiological (manometry) and cross sectional (endoscopic ultrasound) data to determine if PPI or Jorveza are superior treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122242 0
A/Prof Hamish Philpott
Address 122242 0
Lyell McEwin Hospital
Haydown Rd, Elizabeth Vale SA 5112
Country 122242 0
Australia
Phone 122242 0
+61421227551
Fax 122242 0
Email 122242 0
hamish.philpott@sa.gov.au
Contact person for public queries
Name 122243 0
Dr Van MT Hoang
Address 122243 0
Lyell McEwin Hospital
Haydown Rd, Elizabeth Vale SA 5112
Country 122243 0
Australia
Phone 122243 0
+61 0881829452
Fax 122243 0
Email 122243 0
van.hoang@sa.gov.au
Contact person for scientific queries
Name 122244 0
A/Prof Hamish Philpott
Address 122244 0
Lyell McEwin Hospital
Haydown Rd, Elizabeth Vale SA 5112
Country 122244 0
Australia
Phone 122244 0
+61 0881829000
Fax 122244 0
Email 122244 0
hamish.philpott@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
de-identification data collected during the trial
When will data be available (start and end dates)?
Immediately following publication and ending 5 years following main results publication.
Available to whom?
only researchers who provide a methodologically sound proposal, determined by PI
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator. Request should be sent to Dr Hamish Philpott at hamish.philpott@sa.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18324Study protocol    384796-(Uploaded-11-02-2023-22-28-26)-Study-related document.docx



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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