Esomeprazole for Dyspepsia

Inclusion criteria

• {"criterion_text":"- Age 18-60 years at the time of enrolment\n- Unexplained dyspepsia\n- H. pylori negative\n- No PPI therapy for the last three months\n- Previous upper endoscopy normal\n- Ability to understand Icelandic or English"}

Exclusion criteria

• {"criterion_text":"- History of upper gastrointestinal malignancy\n- Use of oral anticoagulants\n- Heart, kidney, liver and pulmonary failure\n- Active malignancy, autoimmune, neurological diseases\n- Predominant heartburn and/or acid regurgitation\n- More than minor heartburn and acid reflux on GSRS\n- Predominant symptoms of IBS\n- Known allergy to esomeprzole, Rennie and its components\n- Chronic alcohol or substance abuse (cannabis, amphetamine, cocaine), overconsumption of alcohol\n- Lactose intolerance\n- PPI use within the last 3 months\n- NSAID use 2 weeks prior to study\n- Previous upper endoscopy abnormal\n- Inability to sign informed consent\n- Inability to understand Icelandic or English\n- Eradication of H. pylori within 12 months\n- Use of biological therapy"}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Change in mean daily modified GDSS measured from Days 1-7 compared to Days 8-28; between-arm difference used to assess non-inferiority with margin of 2 points."}

Secondary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Analysis uses a linear mixed effects model of daily modified GDSS with an arm-by-time-period interaction (time period: week 1 vs weeks 5-7). Also measures incidence rate of referrals to upper gastrointestinal endoscopy during study weeks 1-7."}

Iceland

Earliest CTIS Part Ii Submission Date

09-01-2026

Latest Decision Or Authorization Date

06-02-2026

Processing Time Days

28

Number Of Sites

1

Number Of Participants

128

Primary sponsor

Full Name

Landspitali

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Iceland