Gastroesophageal Reflux Clinical Trial
Official title:
Complete Remission: Evaluation of the Complete Remission Rates in Patients With Symptomatic Non-erosive Reflux Disease (NERD) or Erosive Gastroesophageal Reflux Disease (GERD) Treated With Pantoprazole 40 Milligram o.d. Over 4 or 8 or 12 Weeks
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and
esophagus. GERD occurs when the lower esophageal sphincter does not close properly and
stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common
medical disorders, with estimates of up to 50% of adults reporting symptoms related to
gastric reflux. Proton pump inhibitors (PPI) such as pantoprazole can relieve symptoms of
GERD in a large proportion of patients.
When refluxed stomach acidic content touches the lining of the esophagus, it causes a
burning sensation in the chest or throat. This sensation is often referred to as heartburn.
Some patients have symptoms of GERD without visible destruction of the tissue surface (no
visible changes by endoscopic examination).
The aim of the study is to evaluate the effect of pantoprazole on the complete remission of
GERD. Complete remission is defined as endoscopically confirmed healing and symptom relief
after a maximum of 12-week treatment period. Pantoprazole will be administered once daily in
the morning. Endoscopy will be performed at the start of the study, and then as required
after 4, 8, or 12 weeks. The study will provide further data on safety and tolerability of
pantoprazole.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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