A Study of Nexium (Esomeprazole) 40 mg Once Daily in Subjects With Symptoms of Gastroesophageal Reflux Disease (GORD) After Treatment With a Full Dose of Proton Pump Inhibitor (PPI)

Phase 4

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: Esomeprazole 40 mg; Procedure: Physical Exam; Other: Quality of Life Questionnaires; Procedure: pregnancy test, if applicable

• Registration Number: NCT00734097
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-08-11
• Study First Submitted QC: 2008-08-12
• Study First Posted: 2008-08-13
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-09-25
• Status Verified: 2012-08
• Results First Submitted QC: 2012-09-10
• Last Update Submitted: 2012-09-10
• Results First Posted: 2012-10-10
• Last Update Posted: 2012-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 314

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nexium 40 mgs	Esomeprazole 40 mg	-
Nexium 40 mgs	Physical Exam	-
Nexium 40 mgs	Quality of Life Questionnaires	-
Nexium 40 mgs	pregnancy test, if applicable	-

Primary Outcome Measures

Name	Time	Method
Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment	At Baseline and 8 weeks	Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline

Secondary Outcome Measures

Name	Time	Method
Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment	At Baseline and 4 weeks	Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline.
Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment	At Baseline and 8 weeks	Reported severity of heartburn at week 8 on RDQ - reported severity of heartburn at baseline on RDQ RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".; Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment	At Baseline and 4 weeks	Reported severity of heartburn at week 4 on RDQ - reported severity of heartburn at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".; Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.	At Baseline and 4 weeks.	Reported frequency of days with Acid regurgitation at week 4 - reported frequency of days with acid regurgitation at baseline.; Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.	At Baseline and 8 weeks.	Reported frequency of days with Acid regurgitation at week 8 - reported frequency of days with acid regurgitation at baseline.; Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Change in Frequency of Epigastric Pain After 4 Weeks of Treatment	At Baseline and 4 weeks	Reported frequency of days with Epigastric Pain at week 4 - reported frequency of days with Epigastric Pain at baseline.; Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Change in Frequency of Epigastric Pain After 8 Weeks of Treatment	At Baseline and 8 weeks	Reported frequency of days with Epigastric Pain at week 8 - reported frequency of days with Epigastric Pain at baseline.; Four dimensions are defined for the Reflux Disease Questionnaire (RDQ) - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension were range from 0 to 5 for frequency (not present to daily) and severity (not present to severe).
Change in Severity of Epigastric Pain After 8 Weeks of Treatment	At Baseline and 8 weeks	Reported severity of epigastric pain at week 8 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".; Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Change in Severity of Epigastric Pain After 4 Weeks of Treatment	At Baseline and 4 weeks	Reported severity of epigastric pain at week 4 on RDQ - reported severity of epigastric pain at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".; Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Change in Severity of Acid Regurgitation After 8 Weeks of Treatment	At Baseline and 8 weeks	Reported severity of acid regurgitation at week 8 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".; Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).
Change in Severity of Acid Regurgitation After 4 Weeks of Treatment	At Baseline and 4 weeks	Reported severity of acid regurgitation at week 4 on RDQ - reported severity of acid regurgitation at baseline on RDQ (RDQ: Reflux Disease Questionnaire - by AstraZeneca LLP, 2000, values from "None" to "Severe".; Four dimensions are defined for the RDQ - heartburn, regurgitation, GORD dimension and dyspepsia: stomach. Scores for each dimension are range from 0 to 5 for frequency (not present to daily) and/or severity (not present to severe).

Trial Locations

Locations (1)

Research Site; 🇻🇪 San Cristobal, Venezuela