TerminatedPhase 4

The Clinical Significance of Acid Rebound in Functional Dyspepsia

Denmark184 participantsStarted 2011-05

Plain-language summary

Proton pump inhibitors (PPI) have been shown to cause acid reflux related symptoms at withdrawal in healthy volunteers, a phenomenon known as Rebound Acid Hyper Secretion. Whether this also applies for patients with dyspeptic symptoms but without true reflux disease (functional dyspepsia) treated with PPI is unknown. If this is the case, it could lead to an unfortunate long term use of PPI, since the acid rebound renders withdrawal too difficult. This is a single centre, randomized, double-blinded, placebo-controlled cross over study. Study period is 12 weeks per study subject. Study subjects are referred to the study from General Practitioner (GP) and the gastroenterology department or endoscopy clinic of the investigational centre. The study population consists of patients who seek their GP because of dyspepsia without alert signs, and whom the GP may consider starting on PPI. Out patients referred to the gastroenterology department or endoscopy clinic of the investigational centre because of dyspepsia without specific exclusion criteria are also invited to participate. Baseline interview, upper endoscopy and pH monitoring are performed one week before inclusion to exclude patients with GERD. Helicobacter Pylori (Hp.) status is assessed by Helicobacter Urease Test (HUT). Hp. positive subjects without ulcus are not excluded. Patients with a positive pH monitoring will not be included in the analysis regarding the primary endpoint (Development of GERD) but will be included in the analysis regarding one of the secondary endpoints (Effect of PPI on Functional Dyspepsia). Study subjects are randomized to either pantoprazol followed by cross over to placebo or to placebo. Escape medication in the form of Gaviscon can be used on demand. Internet based questionnaires are answered weekly. Questionnaires consist of the Gastrointestinal Symptom rating Scale (GSRS) in combination with items assessing postprandial fullness and items assessing the Montreal Criteria for Gastro Esophageal Reflux Disease (GERD). Compliance to protocol is assessed at hospital visits every fourth week. At the end of study endoscopy and pH monitoring are repeated.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Symptoms indicating dyspepsia, including: * Epigastric pain or epigastric discomfort * Bothersome postprandial fullness * Early satiation * Epigastric burning * Access to internet Exclusion Criteria: * Daily use of PPI or H2-receptor antagonists in more than 28 days within the last 120 days OR more than two days within the last 28 days OR more than five non-consecutive days within the last 28 days. * Mild heartburn or regurgitation more than once per week * Moderate or severe heartburn or regurgitation at least once per week * Complications to GERD (esophagitis, stricture or Barrett's esophagus) prior to enrolment or at screening * Abnormal findings at upper endoscopy necessitating treatment * Abnormal pH-monitoring prior to enrolment or at screening (pH \<4 in ≥5.5 % of the time on "worst day" of 48-h monitoring) * Excludes data from analysis regarding primary endpoint (see summary) * Previous surgery on esophagus, stomach or duodenum * Regular use of NSAIDs through the last six months * Potential language problems in understanding information and registering symptoms * Pregnancy or breast feeding * Other diseases which can interfere with the symptom registration (severe congestive heart disease, malignant disease, schizophrenia ect.) * Abuse of alcohol/narcotics * Allergy/intolerance to gelatine or lactose used in placebo * Patients with pacemaker, Implantable Cardioverter Defibrillator or Implantable Neurostimulator

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Development of GERD

Timeframe: week 9 - 12

Trial details

NCT IDNCT01373970

SponsorZealand University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-05

View on ClinicalTrials.gov More Functional Dyspepsia trials