Clinical trial NCT00734097: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Keywords: heartburn
reflux
proton
pump
inhibitor
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-08-13
Enrollment: 314
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Frequency of Days With Heartburn From Baseline to 8 Weeks of Treatment
timeFrame: At Baseline and 8 weeks
Secondary outcomes:
measure: Change in Frequency of Days With Heartburn From Baseline to 4 Weeks of Treatment
timeFrame: At Baseline and 4 weeks
measure: Change in Severity of Heartburn From Baseline to 8 Weeks of Treatment
timeFrame: At Baseline and 8 weeks
measure: Change in Severity of Heartburn From Baseline to 4 Weeks of Treatment
timeFrame: At Baseline and 4 weeks
measure: Change in Frequency of Days With Acid Regurgitation From Baseline to 4 Weeks of Treatment.
timeFrame: At Baseline and 4 weeks.
measure: Change in Frequency of Days With Acid Regurgitation From Baseline to 8 Weeks of Treatment.
timeFrame: At Baseline and 8 weeks.
measure: Change in Frequency of Epigastric Pain After 4 Weeks of Treatment
timeFrame: At Baseline and 4 weeks
measure: Change in Frequency of Epigastric Pain After 8 Weeks of Treatment
timeFrame: At Baseline and 8 weeks
measure: Change in Severity of Epigastric Pain After 8 Weeks of Treatment
timeFrame: At Baseline and 8 weeks
measure: Change in Severity of Epigastric Pain After 4 Weeks of Treatment
timeFrame: At Baseline and 4 weeks
measure: Change in Severity of Acid Regurgitation After 8 Weeks of Treatment
timeFrame: At Baseline and 8 weeks
measure: Change in Severity of Acid Regurgitation After 4 Weeks of Treatment
timeFrame: At Baseline and 4 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Research Site
city: Santiago de Chile
country: Chile
facility: Research Site
city: Temuco
country: Chile
facility: Research Site
city: Vina del Mar
country: Chile
facility: Research Site
city: Barranquilla
country: Colombia
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Medellin
country: Colombia
facility: Research Site
city: Barquisimeto
country: Venezuela
facility: Research Site
city: Caracas
country: Venezuela
facility: Research Site
city: San Cristobal
country: Venezuela
facility: Research Site
Study officials:
References: