PPI Sequencing Study - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00384592

Purpose

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	Intervention	Phase
Gastro-Oesophageal Reflux Disease	Drug: Esomeprazole Procedure: Physical exam Procedure: Pregnancy test if applicable	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Esophagus Disorders GERD Heartburn

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	100
Study Start Date:	September 2006
Study Completion Date:	May 2007
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384592

Locations

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

Study Director:	Rhiannon Rowsell, MD	AstraZeneca
Principal Investigator:	Roger Jones, MD	UCL

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00384592 History of Changes
Other Study ID Numbers:	D9612L00104
Study First Received:	October 5, 2006
Last Updated:	March 10, 2009
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

heartburn
reflux
proton pump inhibitor
GERD
GORD

Additional relevant MeSH terms:

Esophageal Diseases
Gastroesophageal Reflux
Gastrointestinal Diseases
Digestive System Diseases
Esophageal Motility Disorders
Deglutition Disorders
Omeprazole

Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012