A Randomized, Non-inferiority Trial Comparing 7-Day Versus 4-Week Esomeprazole Treatment in Patients with Unexplained Dyspepsia

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524044-35-00

Enrollment

128

Registered

2026-02-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia

Brief summary

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).

Detailed description

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.

Interventions

DRUGEsomeprazol Krka 40 mg magensaftresistente Hartkapseln

DRUGRennie 680 mg/80 mg tuggutöflur

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 7, 2026