ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Eosinophilic oesophagitis (EoE)

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

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]

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]

Histology results of eosophageal biopsy demosntrating either <15 or >15 eosinophils per high power field (hpf).

Timepoint [1]

8 weeks post randomisation

Primary outcome [2]

Histology results of eosophageal biopsy demonstrating either <15 or >15 eosinophils per high power field (hpf).

Timepoint [2]

16 weeks post randomisation.

Secondary outcome [1]

Change in Endoscopic Reference Score (EREFS; range 0-9).

Timepoint [1]

Outcomes will be assessed at baseline (enrolment day), and upon endoscopy at 8 weeks and 16 weeks post randomisation.

Secondary outcome [2]

Change in Clinical Symptoms (Symptom-Based Activity Index for Adults with Eosinophilic Esophagitis [EEsAI PRO]).

Timepoint [2]

Outcomes will be assessed at baseline (enrolment day), 8 weeks and 16 weeks post randomisation.

Secondary outcome [3]

Change in quality of life measured using the Esophageal Hypervigilance and Anxiety Scale.

Timepoint [3]

Outcomes will be assessed at baseline (enrolment day), 8 weeks and 16 weeks post randomisation.

Secondary outcome [4]

Change in oesophageal wall thickness (ultrasound observation).

Timepoint [4]

Outcomes will be assessed at baseline (enrolment day), and upon endoscopy at 8 weeks and 16 weeks post randomisation.

Secondary outcome [5]

Change in oesophageal peristalsis at manometry.

Timepoint [5]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,SA,VIC

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Northern Adelaide Local Health Network

Address [1]

Lyell McEwin Hospital, Haydown Rd, Elizabeth Vale SA 5112

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network HREC

Ethics committee address [1]

Level 3, Roma Mitchell House 136 North Terrace Adelaide, South Australia, 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

13/02/2023

Approval date [1]

01/08/2023

Ethics approval number [1]

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

A/Prof Hamish Philpott

Address

Lyell McEwin Hospital
Haydown Rd, Elizabeth Vale SA 5112

Country

Australia

Phone

+61421227551

Fax

[email protected]

Contact person for public queries

Name

Van MT Hoang

Address

Lyell McEwin Hospital
Haydown Rd, Elizabeth Vale SA 5112

Country

Australia

Phone

+61 0881829452

Fax

[email protected]

Contact person for scientific queries

Name

Hamish Philpott

Address

Lyell McEwin Hospital
Haydown Rd, Elizabeth Vale SA 5112

Country

Australia

Phone

+61 0881829000

Fax

[email protected]

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 [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
18324	Study protocol					384796-(Uploaded-11-02-2023-22-28-26)-Study-related document.docx

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.

Trial Review

Documents added manually

Documents added automatically