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PPI Sequencing Study

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ClinicalTrials.gov Identifier: NCT00384592
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : March 11, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastro-Oesophageal Reflux Disease Drug: Esomeprazole Procedure: Physical exam Procedure: Pregnancy test if applicable Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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)
Study Start Date : September 2006
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD Heartburn




Primary Outcome Measures :
  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 Outcome Measures :
  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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384592


Locations
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United Kingdom
Research Site
Allerton, United Kingdom
Research Site
Ashford, United Kingdom
Research Site
Atherstone, United Kingdom
Research Site
Ayrshire, United Kingdom
Research Site
Bath, United Kingdom
Research Site
Blackpool, United Kingdom
Research SIte
Bolton, United Kingdom
Research Site
Coventry, United Kingdom
Research Site
Fowey, United Kingdom
Research SIte
Glasgow, United Kingdom
Research Site
Hamilton, United Kingdom
Research Site
Motherwell, United Kingdom
Research Site
Stevenage, United Kingdom
Research Site
Warminster, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Rhiannon Rowsell, MD AstraZeneca
Principal Investigator: Roger Jones, MD UCL

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ClinicalTrials.gov Identifier: NCT00384592     History of Changes
Other Study ID Numbers: D9612L00104
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: March 11, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
heartburn
reflux
proton pump inhibitor
GERD
GORD

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esomeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action