Study of Long-Term Use of Proton-Pump-Inhibitors in General Practice
With-Drawal Study of Proton-Pump-Inhibitors in Patients From Primary Care Who Have Previously Been Treated on a Long-Term Basis
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The majority of patients with dyspepsia are treated in primary care with acid-suppressive therapy for shorter or longer periods of time on the assumption that the patients´ symptoms are related to the production of acid in the stomach.
In about half of the dyspeptic patients there is no structural or biochemical explanation for their symptoms. These patients suffer from functional dyspepsia.
Treatment with proton-pump-inhibitors is effective in treating patients with gastroesophageal refluxdisease or ulcers. It is however controversial if acid-suppressive treatment is effective in the large group of patients with functional dyspepsia. Previous studies have shown no or very modest effect with a very high placeboresponse rate of 40-50%.
In primary care patients with upper abdominal symptoms are often treated with PPI as a diagnostic tool. If the treatment is effective continued or repeated treatment with PPI is often favored. However some of the patients must experience the abovementioned placebo-effect. These patients may end up being treated with PPI long-term on uncertain indication.
We wish to investigate the consequences of withdrawing treatment with PPI in patients from general practice who have previously been treated long-term.
An upper endoscopy is performed in patients who experience upper abdominal symptoms after withdrawal of treatment.If the endoscopy is normal patients are randomised to 1 week treatment with either esomeprazole or placebo.
Tipo di studio
Iscrizione
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
-
-
-
Glostrup, Danimarca, 2600
- Reclutamento
- Department of gastroenterology, Glostrup University Hospital
-
Contatto:
- Christina Reimer, MD
- Numero di telefono: 43 23 27 79
- Email: chrrei01@glostruphosp.kbhamt.dk
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Treatment with PPI in at least 4 months out of the preceding 12.
- Use of PPI in the preceding 10 out of 30 days before inclusion
- Age above 18 years
Exclusion Criteria:
- Erosive Esophagitis
- PPI-treatment as prophylaxis against gastrointestinal bleeding
- PPI-treatment as prophylaxis against ulcers
- PPI-treatment as prophylaxis because of NSAID-treatment
- Pregnant or lactating women
- Previous upper GI surgery
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
|---|
|
Comparison of the effect of treatment in one week with esomeprazole and placebo measured as symptomscore in patientdiary.
|
Misure di risultato secondarie
Misura del risultato |
|---|
|
Fraction of patients who are willing to withdraw treatment with PPI
|
|
Fraction of patients who experience symptoms after withdrawal of treatment.
|
|
Description of endoscopic findings in patients who have previously been treated with PPI long-term and who after withdrawal are symptomatic
|
|
Length of time from withdrawal till symptoms arise
|
|
Correlation between levels of gastrin and CgA and time till symptoms arise
|
|
Investigators and patients ability to distinguish between active and placebo treatment
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Peter Bytzer, ass. professor, ph.d, Glostrup University Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 001 (Marta Eliza Miller Foundation)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .