| Study Number | Study Phase | Start Date | Recruitment Status |
| 1312004007 | Non-interventional study | 1 Sep 2005 | Completed |
| German PMS trial (AWB) to evaluate therapy in reflux disease and NSAR-symptoms |
| 1312004008 | Non-interventional study | 06-Sep-2005 | Completed |
| Symptoms and endoscopic results in cconsideration of pretreatment |
| 1312004011 | Non-interventional study | 14-Jan-2006 | Completed |
| Trans GERD |
| 294 | Phase II/III | 10-May-2001 | Completed |
| Laryngopharyngeal Reflux Health related Quality of Life (LPR-HRQL) Questionnaire Development and Psychometric testing in Patients Receiving Omeprazole 20 mg bid as Treatment for Laryngopharyngeal Reflux. |
| 322 | PhaseIV | 18 Dec 2008 | Completed |
| A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 weeks of Treatment with Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients with Moderate or Severe Erosive Esophagitis. |
| 25N54 | Phase IV | 02-Jan-2003 | Completed |
| The proton pump inhibitor test in reflux disease: a study using Nexium in general practice patients |
| D9612C00025 | Phase III | 24-Jun-2003 | Completed |
| A Phase III, Multicenter, Open-Label Study To Evaluate the Control of Gastric Acid Secretion with Esomeprazole In Patients With Gastric Acid Hypersecretory States Including Idiopathic Hypersecretion and Zollinger-Ellison Syndrome For 12 Months |
| D9612L00062 | Phase IV | 29-Jun-2004 | Completed |
| A Multicenter, Double-Blind, Randomized Trial of the Relationship of Intragastric Acid Control and Healing Status of Moderate and Severe Erosive Esophagitis After Treatment with Esomeprazole Magnesium (NEXIUM®) 10 mg and 40 mg Once Daily |
| D9612L00064 | Phase IV | 11-Nov-2004 | Completed |
| A 4-week Study to Investigate the Relationship Between Resolution of Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Magnesium |
| D9612L00066 | Phase IV | 4-Oct-2004 | Completed |
| A Randomized, Open-Label, Comparative, Two-Treatment, Crossover Study of the 24-Hour Intragastric pH Profile After 5 Days of Once Daily Oral Administration of Either Esomeprazole 40 mg or Pantoprazole 40 mg Following Once Daily Infusion of Intravenous Pantoprazole 40 mg for 5 Days in Healthy Volunteer Subjects |
| D9612L00076 | Phase IV | 15-May-2006 | Active, not recruiting |
| Development of an Algorithm for Identification of Responders to Short Term Treatment with Esomeprazole (Nexium) in Primary Care. |
| D9612L00078 | Phase III | 08-Apr-2005 | Completed |
| An open-label, parallel-group, multi-centre study to determine the effect of treatment with esomeprazole for six months on histological markers of esophageal epithelial acid-related disease in patients with upper GI symptoms. The HEARD study – Histology of the Esophagus in Acid-Related Disease. |
| D9612L00080 | Phase IV | 15-Aug-2005 | Completed |
| A Randomized, Open-Label, Comparative, Two-Treatment, Crossover Study of 24-hour Intragastric pH Profiles of Esomeprazole 40 mg and Lansoprazole 30 mg in Healthy Volunteer Subjects on Days 1 and 5 of Intravenous Treatment |
| D9612L00083 | Phase IV | 19-Oct-2005 | Completed |
| An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients with Symptoms of Gastroesophageal Reflux Disease (GERD) to Investigate the Relationship between the Presence of Erosive Esophagitis (EE) at Baseline and Heartburn Resolution after 4 Weeks of Treatment |
| D9612L00085 | Phase IV | 09-Dec-2005 | Completed |
| A randomised, open, phase IV, parallel group multicentre study to evaluate a change of management in Gastroesophageal Reflux Disease (GERD) patients by treatment with esomeprazole 40 mg or any other Proton Pump Inhibitor (PPI), after initial treatment failure, in ordinary clinical practice during 4 weeks. |
| D9612L00096 | Phase IV | 15-Oct-2005 | Completed |
| A Cluster-Randomized Study to Examine National Characteristics and Outcome Measures of GERD patients utilizing the PPI Acid Suppression Symptom (PASS) test for response [EncomPASS]. |
| D9612L00097 | Phase IV | 05-Sep-2005 | Completed |
| USE OF ESOMEPRAZOLE IN POSTOPERATIVE BARIATRIC SURGERY PATIENTS USERS AND NON-USERS OF NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs). |
D9612L00116 | Phase IV | 13 Nov 2007 | Active, not recruiting |
| 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) |
| D9614C00007 | Phase I | 14 Aug 2006 | Completed |
| A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Single Oral Doses of Esomeprazole Magnesium in Pediatric Patients 1 to 11 Years-Old Inclusive with Endoscopically-Proven Gastroesophageal Reflux Disease (GERD) |
| D9614C00097 | Phase III | 13-Oct-2004 | Completed |
| A Phase III, Multicentre, Randomized, Double-blind Parallel-group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients 1 to 11 Years of Age, Inclusive. |
| D9614C00098 | Phase III | 24-Feb-2004 | Completed |
| A Phase III, Multicentre, Randomized, Double-blind, Parallel-group Study to Evaluate the Safety of Once Daily Esomeprazole for the Treatment of Clinically Diagnosed Gastroesophageal Reflux Disease (GERD) in Pediatric and Adolescent Patients 12 to 17 Years of Age, Inclusive. |
| D9617C00011 | Phase III | 13-May-2004 | Completed |
| A randomized double-blind placebo-controlled study to assess the prevention of low-dose acetylsalicylic acid (ASA) associated gastroduodenal lesions and upper gastrointestinal symptoms in patients taking esomeprazole 20 mg once daily for 26 weeks. |
| D9617C00001 | Phase III | 08-Jan-2001 | Completed |
| Efficacy of esomeprazole 40 mg once daily versus placebo and esomeprazole 20 mg once daily versus placebo in treatment for relief of upper gastrointestinal symptoms associated with continuous use of NSAIDs including COX-2 selective NSAIDs. |
| D9617C00002 | Phase III | 26-Feb-2001 | Completed |
| Efficacy of esomeprazole 40 mg once daily versus placebo or esomeprazole 20 mg once daily versus placebo in prevention of upper gastrointestinal symptoms associated with continuous use of NSAIDs including COX-2 selective NSAIDs. |
| D9617C00003 | Phase III | 11-Dec-2000 | Completed |
| Efficacy of esomeprazole 40 mg once daily versus placebo and esomeprazole 20 mg once daily versus placebo in treatment for relief of upper gastrointestinal symptoms associated with continuous use of NSAIDs including COX-2 selective NSAIDs |
| D9617C00004 | Phase III | 02-Apr-2001 | Completed |
| Efficacy of esomeprazole 40 mg once daily versus placebo or esomeprazole 20 mg once daily versus placebo in prevention of upper gastrointestinal symptoms associated with continuous use of NSAIDs including COX-2 selective NSAIDs |
| D9618C00001 | Phase II | 03-Apr-2006 | Completed |
| A 6-month randomized, double-blind, parallel-group, multicentre, placebo-controlled Phase II study to compare anti-asthmatic effect and safety of esomeprazole (Nexium®) 40 mg twice daily or 40 mg once daily with placebo in adults with asthma. |
| D961DC00001 | Phase III | 15-Oct-2005 | Completed |
| A randomised, double-blind, parallel-group, placebo controlled study of esomeprazole i.v. (bolus infusion of 80 mg followed by a continuous infusion of 8 mg per hour) administered for 72 hours to assess prevention of rebleeding in subjects that have undergone successful primary endoscopic haemostasis of a bleeding peptic ulcer – the PUB study.. |
| D961FC00002 | Phase I | 14 Apr 2008 | Active, not recruiting |
| A Phase I, Open-label, Randomized, Single-center, 2-stage Group Sequential Design, 2-way Crossover Bioequivalence Study Comparing a Fixed-dose Combination Capsule of Esomeprazole 40mg and Low-dose Acetylsalicylic Acid (ASA) 325mg with a Free Combination of Esomeprazole Capsule 40mg and Low-dose ASA. |
| D961HC00001 | Phase III | 25 Aug 2007 | Recruiting |
| A Phase III, Multicentre, Randomised, Double-blind, Pararell-group, Comparative Efficacy and Safety Study of D961H (20 mg once daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated with Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use. |
| D961HC00002 | Phase III | 11 Dec 2007 | Recruiting |
A multicentre, randomised, double-blind, parallel-group, comparative study to compare the efficacy and safety of D961H 20 mg and 40 mg once daily oral administration with omeprazole 20 mg once daily oral administration in patients with reflux esophagitis. |
|
| D961HC00005 | Phase III | 05 Oct 2007 | Recruiting |
| A Long Term Study to Investigate the Efficacy and Safety Study of D961H (20 mg once daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated with Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use. |
| D961HC00006 | Phase III | 8 Jan 2008 | Recruiting |
| A multicentre, randomised, double-blind, parallel-group, comparative study to compare the efficacy and safety of D961H 20 mg once daily oral administration with omeprazole 10 mg and D961H 10 mg once daily oral administration in maintenance treatment in patients with healed reflux esophagitis. |
D961HC00007 | Phase I | 10 Apr 2008 | Recruiting |
| A single-centre, open, randomised, three-way cross-over drug-drug interaction study of D961H capsule and loxoprofen tablet after repeated oral administration in Japanese healthy male subjects |
| D9770C00011 | Phase II | | Completed |
| A 4-week, randomised, double-blind, multicentre, dose-finding phase IIb study with AZD0865 25, 50, 75 mg and esomeprazole 20 mg, given orally once daily for the treatment of GERD without erosive esophagitis according to the LA classification in adult subjects. |
| D9770C00012 | Phase II | | Completed |
| A randomised, double-blind, multicentre dose-finding Phase IIb study for up to 8 weeks’ treatment with AZD0865 25, 50, 75 mg and esomeprazole 40 mg, given orally once daily for the healing of erosive esophagitis in adult subjects with GERD with erosive esophagitis according to the LA classification in adult subjects. |
| D9914C00001 | Phase IIIA | 27-May-2004 | Completed |
| A Randomized Double-Blind Placebo-Controlled Multi-Centre Pilot Study to Assess Symptom Response in Subjects with Pain or Discomfort in the Chest Receiving Oral Treatment with Esomeprazole 40 mg bid for 4 weeks. |
| D9914C00002 | Phase IV | 15-Sept-2005 | Completed |
| A single-blind single arm study to validate the Reflux Disease Questionnaire (RDQ) for the diagnosis of reflux disease in primary care in patients treated with esomeprazole 40 mg o.d. |
| SD-NED-0021 | Phase IIIA | 7-Dec-2002 | Completed |
| Supportive Test for Acid-Related Symptoms (STARS I) with esomeprazole and a following 7-week, double-blind, randomized, placebo controlled treatment period in subjects with upper gastrointestinal symptoms and with normal findings at esophagogastroduodenoscopy. |
| SD-NED-0022 | Phase III | 7-Dec-2002 | Completed |
| Supportive Test for Acid-Related Symptoms (STARS II) with esomeprazole and a following 7-week, double-blind, randomized, placebo controlled treatment period in uninvestigated subjects with upper gastrointestinal symptoms. |
| SH-NEE-0002 | Phase II | 19-Feb-2002 | Completed |
| A Multicenter, double -blind, Placebo-controlled Study to evaluate the effects of Esomeprazole 40mg bid on the signs and symptoms of Chronic Posterior Laryngitis with suspected Laryngopharyngeal Reflux. |
| D9612C00003 | Phase III | 16-Oct-2001 | Active, not recruiting |
| An open, randomized, multicenter, phase IIIB study during 5 years to assess long-term efficacy and tolerability of esomeprazole compared to laparascopic anti-reflux surgery in adult subjects with gastroesophageal reflux disease – LOTUS. |
| D9612L00104 | Phase IV | 3-Sep-2006 | Completed |
| A study to Assess the effectiveness of Esomeprazole 40 mg once daily in subjects with continuing Gastroesophageal Reflux Disease (GORD) symptoms following treatment wit a previous full dose Proton Pump Inhibitor (PPI). |
| D9612L00109 | Phase IV | 1-Aug-2006 | Completed |
| A randomized, open, parallel-group, multi-national, multi-centre, phase IV study to evaluate the efficacy of three different patient management strategies with and without esomeprazole 20 mg during a 3 months maintenance phase following an initial 4-weeks acute treatment phase in subjects with symptoms thought to be GERD related. |
| D9612L00113 | Non-interventional study | 15-Jan-2008 | Recruiting |
| A cross-sectional, Canadian, multi-centre study of symptom burden and clinical management in subjects with Gastroesophageal Reflux Disease (GERD) RANGE: Retrospective ANalysis of GErd. |
| D9617L00001 | Phase III | 31-Mar-2006 | Recruiting |
| A multicenter, randomized, double-blind, double-dummy, parallel-group, 8 week comparative efficacy and safety study of esomeprazole 20 mg qd versus Ranitidine 150 mg bid in patients with an NSAID-associated gastric ulcer when daily NSAID is continued. |
| D961DL00004 | Phase III | 28-Aug-2006 | Completed |
| A randomised, double-blind, double-dummy, active-controlled, multicenter study to assess the efficacy and safety of esomeprazole or omeprazole for 5 days in subjects with acute non-variceal upper gastrointestinal bleeding. |
D9612L00082 | Phase IV | 3 Jan 2006 | Completed |
An Open-Label, 2-way Crossover Study of Steady-state Intragastric pH Control Comparing 2 Dosage Regimens of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients |
| D9612L00106 | Phase IV | 20-Oct-2006 | Completed |
| A Randomized, Open-Label, Comparative 3-Way Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40 mg, Lansoprazole 30 mg, and Pantoprazole 40 mg at Steady State in Hispanic Patients with Symptomatic GERD |
| D9614C00004 | Phase II/III | 22-Nov-2006 | Recruiting |
| A randomized, double-blind, placebo controlled, study to evaluate the efficacy and safety of esomeprazole once daily for the treatment of gastroesophageal reflux disease (GERD) in neonatal patients, including premature and up to 1 month corrected age. |
| D9612L00107 | Phase IV | 27 Oct 2006 | Completed |
| An Open-Label, Exploratory Trial to Assess Gastric Acid Control in Critically Ill Subjects Receiving Nexium I.V. (esomeprazole sodium) 40mg BID for up to 72 hours |
D961FC00003 | Phase III | 22 Feb 2007 | Completed |
randomized, double-blind, parallel-group, multicentre, phase III study to assess the effect of esomeprazole 20 and 40 mg od versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low dose acetylsalicylic acid (ASA). |
D961FC00004 | Non-interventional study | 14 Jan 2008 | Recruiting |
A prospective descriptive, multi-national, multi-centre observational study of burden of upper GI-symptoms in subjects with cardiovascular risk or disease receiving treatment with low-dose aspirin. |
| D9612L00111 | Phase IV | 1 Mar 2007 | Recruiting |
| A randomized, open, parallel-group study to evaluate the efficacy of three different patient management strategies during a 12 weeks maintenance phase following an initial 4-weeks acute treatment phase in subjects with symptoms thought to be GERD related. |
| D9612L00122 | Phase IV | 18 Apr 2008 | Active, not recruiting |
| A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment with Esomeprazole 20 mg qd to Placebo qd in Patients with Heartburn and Sleep Disturbances Associated with Gastroesophageal Reflux Disease (GERD) |
| D9614C00096 | Phase III | 12 Apr 2007 | Completed |
| Phase 3 Safety & Efficacy of Esomeprazole in Infants. |
D9615C00021 | Phase I | 15 Jun 2007 | Recruiting |
A Phase 1, randomised, open-label, multi-national study to evaluate the pharmacokinetics of repeated once-daily intravenous doses of esomeprazole in paediatric patients 0-17 years old, inclusive. |
N11 | Non-interventional study | 1 Jun 2004 | Completed |
| The effect of lifestyle-adjustments prior to medical treatment on the effect of medical treatment in reflux patients. |
| Non-interventional study | | Completed |
SYNCHRONISE: Esomeprazole 20 mg Once Daily for Relief of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs Including COX-2 Selective NSAIDs in Dutch General Practice: The Influence of Risk-Factors for NSAID-Associated GI Damage on Sympton Response. |
|
| Non-interventional study | | Recruiting |
Prevalence of gastroesophageal reflux during chilhood and teenage years in France |
|
| Non-interventional study | | Recruiting |
Epidemiological Study to Assess the Symptoms and Patterns of Diagnosis and Treatment of the Gastroesophageal Reflux Disease. |
| NIS-GAT-NEX-2007/1 | Non-interventional study | 3 Jul 2007 | Completed |
| LIFE NIS, GERD-Patients - Evaluation of Burden of Disease Determined by GERD Impact Scale (GIS) |
| NIS-GCH-NEX-2007/1 | Non-interventional study | 1 Feb 2008 | Recruiting |
| GERD Segmentation: Document How Swiss GPs Allocate Their GERD Patients to the Three GERD Patient Segments |
| NIS-GUS-DUM-2007/1 | Non-interventional study | 1 Jan 2007 | Active, not recruiting |
| Using an electronic health record-based intervention and broad education reach strategies to improve quality of care for GERD and gastroprotection for patients on NSAIDs: a randomized controlled trial |
| Phase IV | | Terminated |
What is the value of the use of validated questionnaire (Reflux Impact Scale) for predicting treatment success with PPI. |
| Non-interventional study | | Completed |
An epidemiological, observational study to describe symptom control and impact on daily life of GERD in patients with erosive gastroesophageal reflux disease. |
|