The clinical significance of acid rebound: Symptoms of reflux after 8 weeks of PPI treatment in patients with functional dyspepsia.
- Conditions
- Acid-Rebound Hypersecretion and Functional dyspepsiaMedDRA version: 13.1Level: LLTClassification code 10064536Term: Functional dyspepsiaSystem Organ Class: 10017947 - Gastrointestinal disorders
- Registration Number
- EUCTR2011-000059-17-DK
- Lead Sponsor
- Koege Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method