| March 11, 2008 |
| June 10, 2009 |
| June 2002 |
| February 2003 (final data collection date for primary outcome measure) |
| 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 ] |
| Same as current |
| Complete list of historical versions of study NCT00637845 on ClinicalTrials.gov Archive Site |
- 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 ]
|
| Same as current |
| |
| Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent Gastrooesophageal Reflux Disease (GERD) |
| 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. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study |
- Heartburn
- Gastroesophageal Reflux Disease
|
- Drug: Esomeprazole Magnesium
- Drug: Lansoprazole
|
- Experimental: 40mg once daily
- Active Comparator: 30mg twice daily
|
| |
| |
| Completed |
| 248 |
| February 2003 |
| February 2003 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
|
| |
| NCT00637845 |
| Tore Lind, MD - Nexium Medical Science Director, Astra Zeneca |
| 311, D9612L00055 |
| AstraZeneca |
|
| Study Director: |
Paula Fernstrom |
Nexium Global Product Director, AstraZeneca |
|
|
| AstraZeneca |
| June 2009 |
