ESOMEPRAZOLE MAGNESIUM

Post-LOE

esomeprazole magnesium

ANDAORALCAPSULE, DELAYED REL PELLETS
Approved
Mar 2021
Lifecycle
Post-LOE
Competitive Pressure
30/100
Clinical Trials
4

Mechanism of Action

compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Esomeprazole is protonated and converted in the acidic compartment of the parietal cell forming the active…

Clinical Trials (4)

NCT00687245Phase 1Completed

Pharmacokinetic Study of Esomeprazole Magnesium in Patients 1 to 11 Years-Old With Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)

Started Aug 2006
40 enrolled
Endoscopically-Proven GERDReflux
NCT00317044Phase 2Completed

Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma

Started Apr 2006
961 enrolled
AsthmaGERD
NCT00641602Phase 4Completed

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

Started Dec 2002
1,000 enrolled
Erosive Esophagitis
NCT00637845Phase 4Completed

Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent Gastrooesophageal Reflux Disease (GERD)

Started Jun 2002
248 enrolled
HeartburnGastroesophageal Reflux Disease