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)

AstraZeneca314 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

314

Conditions

Gastroesophageal Reflux Disease

Interventions

Esomeprazole 40 mgDRUG

Once a day

Physical ExamPROCEDURE

every visit

Quality of Life QuestionnairesOTHER

every visit

pregnancy test, if applicable

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Research Site

Buenos Aires, Argentina

Research Site

Santiago, Chile

Research Site

Temuco, Chile

Research Site

Viña del Mar, Chile

Outcomes

Primary Outcomes

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

Time frame: At Baseline and 8 weeks

Secondary Outcomes

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.

Time frame: At Baseline and 4 weeks

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).

Time frame: At Baseline and 8 weeks

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).

Time frame: At Baseline and 4 weeks

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).

Data from ClinicalTrials.gov

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Research Site

Barranquilla, Colombia

Research Site

Bogotá, Colombia

Research Site

Medellín, Colombia

Research Site

Barquisimeto, Venezuela

Research Site

Caracas, Venezuela

Research Site

San Cristóbal, Venezuela

Time frame: At Baseline and 4 weeks.

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).

Time frame: At Baseline and 8 weeks.

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).

Time frame: At Baseline and 4 weeks

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).

Time frame: At Baseline and 8 weeks

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).

Time frame: At Baseline and 8 weeks

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).

Time frame: At Baseline and 4 weeks

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).

Time frame: At Baseline and 8 weeks

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).

Time frame: At Baseline and 4 weeks