Skip to main content
OpenTrials
Completed

NCT Number: NCT00384592

PPI Sequencing Study

The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastro-oesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Allerton, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persisting symptoms of GORD despite previous treatment with a full dose proton pump inhibitor
  • Informed consent
  • Over 18 years of age

Exclusion criteria

  • Current course of Proton Pump inhibitor treatment for more than 8 weeks prior to enrolment in the study;
  • More than 1 other course of PPI treatment in the previous 12 month;
  • Previous use of esomeprazole;
  • Presence of alarm symptoms.

Treatment and study plan

Esomeprazole

Drug

Physical Exam

Procedure

Pregnancy test if applicable

Procedure

Primary outcomes

  1. The primary objective of this study is to assess the change in the frequency of heartburn from baseline value at entry to the end of the study, after 8-weeks treatment with esomeprazole 40mg compared to previous full dose treatment with a PPI daily

Secondary outcomes

  1. Change in frequency and severity of heartburn, epigastric pain and acid regurgitation after 4 and 8 weeks treatment from baseline value at study entry

  2. Change in symptom control from baseline to 4 and 8 weeks using QOL questionnaires

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Study to Assess the Effectiveness of Esomeprazole 40 mg Once Daily in Subjects With Continuing Gastroesophageal Reflux Disease (GORD) Symptoms Following Treatment Wit a Previous Full Dose Proton Pump Inhibitor (PPI)

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Oct 6, 2006
Registry last updated
Mar 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.