PPI Sequencing Study

Gastro-Oesophageal Reflux Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00384592
• Other study ID #: D9612L00104
• Status: Completed
• Phase: Phase 4
• First received: October 5, 2006
• Last updated: March 10, 2009
• Start date: September 2006
• Est. completion date: May 2007

Study information

• Verified date: March 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastro-Oesophageal Reflux Disease
• Gastroesophageal Reflux

Intervention

Drug:
• Esomeprazole

Procedure:
• Physical exam

• Pregnancy test if applicable

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in frequency and severity of heartburn, epigastric pain and acid regurgitation after 4 and 8 weeks treatment from baseline value at study entry
Secondary	Change in symptom control from baseline to 4 and 8 weeks using QOL questionnaires