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)
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...
Brief Summary
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)”
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
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: October 2008
Intervention(s) in this Clinical Trial
- 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
Arms, Groups and Cohorts in this Clinical Trial
- Other: Nexium 40 mgs
Outcome Measures for this Clinical Trial
Primary Measures
- The primary objective of this study is to asses the change in the frequency of heartburn from entry to the end of the study, after 8-weeks treatment with Esomeprazole 40 mg compared to previous full dose PPI treatment given once daily.
- Time Frame: Every 4 weeks
Safety Issue?: No
- Time Frame: Every 4 weeks
Secondary Measures
- Change in: · 1) frequency and severity of heartburn, epigastric pain and acid regurgitation after 4 and 8 weeks treatment from baseline value at study entry· 2) symptom control from baseline to 4 and 8 weeks using QoL questionnaires
- Time Frame: Every 4 weeks
Safety Issue?: No
- Time Frame: Every 4 weeks
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00734097
Study ID Number: D9612L00116
ClinicalTrials.gov Identifier: NCT00734097
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00734097
