Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
128
Countries
1
Sites
1
Dyspepsia
To assess the difference in symptoms of dyspepsia in Glasgow Dyspepsia Severity Score (GDSS) in patients treated with PPIs for one week vs. 4 weeks.
Key facts
- Sponsor
- Landspitali
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2026-02-06
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Landspitali University Hospital
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To assess the difference in symptoms of dyspepsia in Glasgow Dyspepsia Severity Score (GDSS) in patients treated with PPIs for one week vs. 4 weeks.
Secondary objectives 2
- To assess dyspepsia symptoms at week 5, 6 and 7
- To assess referrals for upper endoscopy in participants
Conditions and MedDRA coding
Dyspepsia
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | A Randomized, Non-inferiority Trial Comparing 7-Day Versus 4-Week Esomeprazole Treatment in Patients See Synopsis
|
Randomised Controlled | Double | [{"id":169167,"code":2,"name":"Investigator"}] |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Age 18-60 years at the time of enrolment
- Unexplained dyspepsia
- H. pylori negative
- No PPI therapy for the last three months
- Previous upper endoscopy normal
- Ability to understand Icelandic or English
Exclusion criteria 17
- History of upper gastrointestinal malignancy
- Lactose intolerance
- PPI use within the last 3 months
- NSAID use 2 weeks prior to study
- Previous upper endoscopy abnormal
- Inability to sign informed consent
- Inability to understand Icelandic or English
- Eradication of H. pylori within 12 months
- Use of biological therapy
- Use of oral anticoagulants
- Heart, kidney, liver and pulmonary failure
- Active malignancy, autoimmune, neurological diseases
- Predominant heartburn and/or acid regurgitation
- More than minor heartburn and acid reflux on GSRS
- Predominant symptoms of IBS
- Known allergy to esomeprzole, Rennie and its components
- Chronic alcohol or substance abuse (cannabis, amphetamine, cocaine), overconsumption of alcohol
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change in mean daily modified Glasgow Dyspepsia Severity Score (GDSS) from Week 1 (Days 1-7) to Weeks 2-4 (Days 8-28); treatment effect is the between-arm difference in this change (non-inferiority margin 2 points).
Secondary endpoints 1
- The arm by time period interaction effect in a linear mixed effects model of the daily modified Glasgow Dyspepsia Score. Time period is a binary variable, the first week vs weeks 5-7.Incidence rate of referrals to upper gastrointestinal endoscopy during study weeks 1 through 7.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Esomeprazol Krka 40 mg magensaftresistente Hartkapseln
PRD444204 · Product
- Active substance
- Esomeprazole
- Pharmaceutical form
- GASTRO-RESISTANT CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- A02BC05 — ESOMEPRAZOLE
- Marketing authorisation
- 1-29045
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
Rennie 680 mg/80 mg tuggutöflur
PRD1720716 · Product
- Active substance
- Magnesium Carbonate Heavy
- Pharmaceutical form
- CHEWABLE/DISPERSIBLE TABLET
- Route of administration
- ORAL
- Max daily dose
- 2 Other
- Max total dose
- 2 Other
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- A02AD01 — ORDINARY SALT COMBINATIONS
- Marketing authorisation
- 910021
- MA holder
- BAYER AB
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Landspitali
2
Total trials
Academic / Non-commercial
- Sponsor organisation
- Landspitali
- Address
- Skaftahlid 24
- City
- Reykjavik
- Postcode
- 105
- Country
- Iceland
Scientific contact point
- Organisation
- Landspitali
- Contact name
- Investigator
Public contact point
- Organisation
- Landspitali
- Contact name
- Project Manager
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Iceland | Authorised, recruitment pending | 128 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol - Template PPI-trial30OCT | 2 |
| Protocol (for publication) | Protocol - Template PPI-trial5OCT | 1 |
| Protocol (for publication) | Protocol - Template PPI-trial9JAN | 3 |
| Recruitment arrangements (for publication) | Rrecruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | samykkisyfirlysing Version2 | 2 |
| Subject information and informed consent form (for publication) | Information Letter in EnglishVersion1 | 1 |
| Subject information and informed consent form (for publication) | Informed consent in English PPI-version1 | 1 |
| Subject information and informed consent form (for publication) | Informed consent PPIDyspepsia | 1 |
| Subject information and informed consent form (for publication) | Upplysingbref f atttakendur-PPI-D | 1 |
| Subject information and informed consent form (for publication) | Upplysingbref f Version2 | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | Esomeprazol_Krka_SmPC | 1 |
| Synopsis of the protocol (for publication) | Islenskur-Icelandic synopsis | 1 |
| Synopsis of the protocol (for publication) | Synopsis of trial | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-06 | Iceland | Acceptable with conditions 2026-02-06
|
2026-02-06 |