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)

Gastroesophageal Reflux Disease Clinical Trial

— NEON  

Official title:

An Open Label, Multicentre 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00734097
• Other study ID #: D9612L00116
• Secondary ID: NEON
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2008
• Last updated: September 10, 2012
• Start date: November 2007
• Est. completion date: October 2008

Study information

• Verified date: August 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaChile: Comisión Nacional de Investigación Científica y TecnológicaColombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosVenezuela: Ministerio de Salud y Desarrollo Social
• 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: 314
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• 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: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Esomeprazole 40 mg
Once a day

Procedure:
• Physical Exam
every visit

Other:
• Quality of Life Questionnaires
every visit

Procedure:
• pregnancy test, if applicable
as needed

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Chile	Research Site	Santiago de Chile
Chile	Research Site	Temuco
Chile	Research Site	Vina del Mar
Colombia	Research Site	Barranquilla
Colombia	Research Site	Bogota
Colombia	Research Site	Medellin
Venezuela	Research Site	Barquisimeto
Venezuela	Research Site	Caracas
Venezuela	Research Site	San Cristobal

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Argentina,  Chile,  Colombia,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment	Reported frequency of days with heartburn at week 8 - reported frequency of days with heartburn at baseline	At Baseline and 8 weeks	No
Secondary	Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment	Reported frequency of days with heartburn at week 4 - reported frequency of days with heartburn at baseline.	At Baseline and 4 weeks	No
Secondary	Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment	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).	At Baseline and 8 weeks	No
Secondary	Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment	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).	At Baseline and 4 weeks	Yes
Secondary	Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.	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).	At Baseline and 4 weeks.	No
Secondary	Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.	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).	At Baseline and 8 weeks.	No
Secondary	Change in Frequency of Epigastric Pain After 4 Weeks of Treatment	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).	At Baseline and 4 weeks	No
Secondary	Change in Frequency of Epigastric Pain After 8 Weeks of Treatment	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).	At Baseline and 8 weeks	No
Secondary	Change in Severity of Epigastric Pain After 8 Weeks of Treatment	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).	At Baseline and 8 weeks	No
Secondary	Change in Severity of Epigastric Pain After 4 Weeks of Treatment	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).	At Baseline and 4 weeks	No
Secondary	Change in Severity of Acid Regurgitation After 8 Weeks of Treatment	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).	At Baseline and 8 weeks	No
Secondary	Change in Severity of Acid Regurgitation After 4 Weeks of Treatment	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).	At Baseline and 4 weeks	No