Authorised Therapeutic use (Phase IV) Dyspepsia

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

EU CTIS ID: 2025-524044-35-00

What this study is testing

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.

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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

You likely can't join if

  • History of upper gastrointestinal malignancy
  • 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • History of upper gastrointestinal malignancy
  • 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
  • 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.