Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent Gastrooesophageal Reflux Disease (GERD)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00637845
First received: March 11, 2008
Last updated: January 20, 2011
Last verified: January 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Heartburn Gastroesophageal Reflux Disease |
Drug: Esomeprazole Magnesium Drug: Lansoprazole |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Drug Information available for:
Magnesium
Omeprazole
Omeprazole magnesium
Lansoprazole
Esomeprazole
Dexlansoprazole
Esomeprazole Sodium
Esomeprazole magnesium
U.S. FDA Resources
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ]
- To assess tolerability of esomeprazole magnesium 40 mg twice daily versus lansoprazole 30 mg twice daily. [ Time Frame: Ongoing Adverse event collection ]
| Enrollment: | 248 |
| Study Start Date: | June 2002 |
| Study Completion Date: | February 2003 |
| Primary Completion Date: | February 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
40mg once daily
|
Drug: Esomeprazole Magnesium
40mg once daily
Other Name: Nexium
|
|
Active Comparator: 2
30mg twice daily
|
Drug: Lansoprazole
30mg twice daily
Other Name: Prevacid
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Tore Lind, MD - Nexium Medical Science Director, Astra Zeneca |
| ClinicalTrials.gov Identifier: | NCT00637845 History of Changes |
| Other Study ID Numbers: | 311, D9612L00055 |
| Study First Received: | March 11, 2008 |
| Last Updated: | January 20, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Nexium Esomeprazole Magnesium Gastroesophageal Reflux Disease Heartburn |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Heartburn Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Signs and Symptoms, Digestive Signs and Symptoms |
Omeprazole Lansoprazole Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents |
ClinicalTrials.gov processed this record on June 17, 2013