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Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA) (Oberon)

12 luglio 2012 aggiornato da: AstraZeneca

A Randomized, Double-blind, Parallel-group, Multicentre, Phase III Study to Assess the Effect of Esomeprazole 20 or 40 mg od Versus Placebo on the Occurrence of Peptic Ulcers During 26 Weeks in Subjects on Continuous Low Dose Acetylsalicylic Acid (ASA)

The purpose of this study is to compare the effect of esomeprazole 20 or 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

2426

Fase

  • Fase 3

Contatti e Sedi

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Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Daily intake of low-dose Aspirin (ASA) - The subject must fulfill at least one of the following (a-e):
  • Aged ≥65 years.
  • Aged ≥18 years and with a documented history of uncomplicated peptic ulcer(s).
  • Aged ≥60 years and naïve to low-dose ASA (ie, treatment started within 1 month prior to randomization).
  • Aged ≥60 years and with stable coronary artery disease.
  • Aged ≥60 years and with complaints of upper gastrointestinal (GI) symptoms that, as judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the finding of ≥5 gastric and/or duodenal erosions at the baseline endoscopy.

Exclusion Criteria:

  • Peptic ulcer(s) at baseline esophagogastroduodenoscopy (EGD).
  • Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline
  • History of peptic ulcer complications such as clinically significant bleeding and/or perforation.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Droga: Placebo
Placebo una volta al giorno
Sperimentale: Esomeprazole 40 mg
Droga: Esomeprazole 40 mg
Esomeprazole 40 mg once daily
Sperimentale: Esomeprazole 20 mg
Droga: Esomeprazole 20 mg
Esomeprazole 20 mg once daily

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Who Experienced the Occurence of Peptic Ulcer(s).
Lasso di tempo: During 26 weeks
The occurrence of ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
During 26 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Who Experienced the Occurence of Gastric Ulcer.
Lasso di tempo: During 26 weeks
The occurrence of gastric ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
During 26 weeks
Percentage of Participants Who Experienced the Occurrence of Duodenal Ulcer.
Lasso di tempo: During 26 weeks
The occurrence of duodenal ulcer (mucosal break measuring >= 3 mm over its largest diameter with a sharply demarcated margin) was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
During 26 weeks
Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Dyspepsia Dimension During the 26-week Visit or the Week Prior to the Last Visit.
Lasso di tempo: RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequence ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). The dyspepsia dimension contains the items 'Burning feeling in the center of the upper stomach' and 'Pain in the center of the upper stomach'. Best score possible 0, worst score possible - daily occurrence.
RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
Number of Participants Reporting 0 in the Dichotomized RDQ (Reflux and Disease Questionnaire) Score (0 Versus >0) for the Gastroesophageal Reflux Disease Dimension During the 26-week Visit or the Week Prior to the Last Visit.
Lasso di tempo: RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
RDQ contains 12 items on a 6-point Likert scale. Six items concern the frequency ('Did not have' to 'Daily') and six items concern the severity ('Did not have' to 'Severe'). Gastroesophageal reflux disease (GERD) items: 'Acid taste in the mouth', 'Unpleasant movement of materials upward from the stomach', 'Burning feeling behind the breastbone' and 'Pain behind the breastbone'. Best score possible 0, worst score possible - daily occurrence.
RDQ was assessed at baseline, 8 weeks, 16 week, 26 weeks or upon withdrawal.
Number of Participants With Gastric and/or Duodenal Erosions.
Lasso di tempo: The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.
The number of erosions was determined by endoscopy performed at baseline, 8 weeks and 26 weeks or upon withdrawal.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Investigatori

  • Direttore dello studio: Tore Lind, MD, PhD, AstraZeneca
  • Investigatore principale: James Scheiman, MD, University of Michigan

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 febbraio 2007

Completamento primario (Effettivo)

1 agosto 2008

Completamento dello studio (Effettivo)

1 agosto 2008

Date di iscrizione allo studio

Primo inviato

27 febbraio 2007

Primo inviato che soddisfa i criteri di controllo qualità

27 febbraio 2007

Primo Inserito (Stima)

1 marzo 2007

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

16 luglio 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 luglio 2012

Ultimo verificato

1 luglio 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D961FC00003
  • EudraCT No. 2006-005073-22

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 .

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Condizioni

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