"Acid-Rebound Hypersecretion" and "Functional dyspepsia" MedDRA version: 13.1 Level: LLT Classification code 10064536 Term: Functional dyspepsia System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Pantoprazol
Pharmaceutical Form: Tablet
INN or Proposed INN: Pantoprazol
CAS Number: 102025-70-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pha
Sponsors
Koege Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18 years + Symptoms of dyspepsia, which GP consider would benefit from PPI treatment. Access to internet. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Signs of severe pathology (extreme weight loss ect.) Symptoms of GORD four weeks before enrolment, according to the Montreal definition. Abnormal pH profile prior to enrolment or at screening. Treatment with PPI or H2-blockers on a regular basis the last year before enrolment Previous surgery on esophagus, stomach or duodenum Use of NSAIDs, antacids, anti-depressives and other analgesics on a regular basis 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.). No access to internet.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparison of number of participants that develop GORD according to the Montreal definition in week 9-12 in the PPI group versus the placebo group. ;Secondary Objective: Comparison of number of participants that develop abdominal pain in week 9-12 in the PPI group versus the placebo group. Comparison of the total amount of consumed antacida in week 9-12 in the PPI group versus the placebo group. Number of patients referred from General Practitioner with esophagitis or Barretts' esophagus without symptoms of reflux. Number of patients referred from General Practitioner with an abnormal pH profile at inclusion without symptoms of reflux. Number of patients with symptoms of colon irritable at inclusion. Comparison of treatment response in patients with co-existing colon irritable in the PPI group versus the placebo group.;Primary end point(s): Comparison of number of participants that develop GORD according to the Montreal defi-nition in weeks 9-12 in the PPI group versus the placebo group: - More than mild reflux symptoms (heartburn or acid regurgitation) on more than one day a week or moderate/severe symptoms on one or more days a week. OR - Complications to GERD (esophagitis, stricture or Barrett’s esophagus) OR - Abnormal pH profile (pH <4 in =5.5 % of the time; middle 24-hour period during 48-h monitoring). | — |
Countries
Denmark
Outcome results
None listed