Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

PPI Sequencing Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00384592
First received: October 5, 2006
Last updated: March 10, 2009
Last verified: March 2009

October 5, 2006
March 10, 2009
September 2006
May 2007   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT00384592 on ClinicalTrials.gov Archive Site
  • Change in frequency and severity of heartburn, epigastric pain and acid regurgitation after 4 and 8 weeks treatment from baseline value at study entry
  • Change in symptom control from baseline to 4 and 8 weeks using QOL questionnaires
Same as current
Not Provided
Not Provided
 
PPI Sequencing Study
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastro-Oesophageal Reflux Disease
  • Drug: Esomeprazole
  • Procedure: Physical exam
  • Procedure: Pregnancy test if applicable
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
May 2007
May 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00384592
D9612L00104
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Rhiannon Rowsell, MD AstraZeneca
Principal Investigator: Roger Jones, MD UCL
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP