- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00637845
Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent Gastrooesophageal Reflux Disease (GERD)
January 20, 2011 updated by: AstraZeneca
A Multi-centred, Phase IV, Post-Marketing, Prospective, Randomized, Double-Blind Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent Gastrooesophageal Reflux Disease While on 30mg Once Daily Lansoprazole Therapy
A double-blind study comparing Esomeprazole Magnesium 40 mg once daily and Lansoprazole 30 mg twice daily to control the symptoms in patients with gastroesophageal reflux disease (GERD) with continued heartburn symptoms with a course of therapy of 30 mg twice daily Lansoprazole.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
248
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subjects must have reported history of heartburn symptoms whilst on lansoprazole 30 mg twice daily during the 30 days prior to screening.
- Subjects must have a minimal cumulative heartburn score of at least 4 for a minimum of 14 days, where zero = none, one = mild, two = moderate, three = severe.
Exclusion Criteria:
- subjects history of esophageal ulcers, esophageal strictures, esophageal neoplasms, gastric or duodenal ulcers, or any other significant gastric or esophageal pathology judged to be clinically significant by the investigator.
- Subjects with persistent heartburn symptoms while on lansoprazole 30 mg twice daily for a period of > 6 months
- Subjects with a history of severe hepatic insufficiency (specifically, Childs-Pugh Class C liver disease) that may adversely affect the metabolism abd pharmacokinetics of esomeprazole and/or lansoprazole.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
40mg once daily
|
40mg once daily
Other Names:
|
Active Comparator: 2
30mg twice daily
|
30mg twice daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare the clinical efficacy of esomeprazole magnesium 40mg once daily versus lansoprazole 30 mg twice daily in symptom control of heartburn in subjects with heartburn symptoms resistant to 30 mg once daily therapy of lansoprazole.
Time Frame: Heartburn symptoms collected on diary card daily
|
Heartburn symptoms collected on diary card daily
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare efficacy of esomeprazole magnesium 40mg daily vs lansoprazole 30 mg twice daily in symptom control of acid regurgitation, epigastric pain, and night-time heartburn in subjects with GERD symptoms resistant to 30 mg daily therapy of lansoprazole
Time Frame: Heartburn symptoms collected on diary card daily
|
Heartburn symptoms collected on diary card daily
|
To evaluate the use of supplementary antacids (as heartburn rescue therapy) in subjects treated with esomeprazole magnesium 40 mg once daily versus lansoprazole 30 mg twice daily
Time Frame: Heartburn symptoms collected on diary card daily
|
Heartburn symptoms collected on diary card daily
|
To assess tolerability of esomeprazole magnesium 40 mg twice daily versus lansoprazole 30 mg twice daily.
Time Frame: Ongoing Adverse event collection
|
Ongoing Adverse event collection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2002
Primary Completion (Actual)
February 1, 2003
Study Completion (Actual)
February 1, 2003
Study Registration Dates
First Submitted
March 11, 2008
First Submitted That Met QC Criteria
March 11, 2008
First Posted (Estimate)
March 18, 2008
Study Record Updates
Last Update Posted (Estimate)
January 21, 2011
Last Update Submitted That Met QC Criteria
January 20, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Gastroesophageal Reflux
- Heartburn
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Dexlansoprazole
- Lansoprazole
- Esomeprazole
Other Study ID Numbers
- 311
- D9612L00055 (Other Identifier: AZ)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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