Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg in Patients With Erosive Gastroesophageal Reflux Disease (PAMES 0109)

Takeda

Status and phase

Completed

Phase 3

Conditions

GERD

Treatments

Drug: Magnesium Esomeprazole

Drug: Magnesium Pantoprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT01132638

PZ-9999-401-BR

U1111-1130-9255 (Registry Identifier)

Details and patient eligibility

About

The aim of this trial is to evaluate the complete remission of erosive gastroesophageal reflux disease with pantoprazole magnesium 40 mg once daily versus esomeprazole 40 mg once daily during four-week treatment with an extension treatment for non-responding patients. The study includes a baseline period up to 14 days and a treatment period of either 4 weeks (28 -2 + 5 days), or 8 weeks depending on the cure of esophagitis due to gastroesophageal reflux. The study will provide further data on safety and tolerability of pantoprazole magnesium.

Enrollment

713 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Voluntary participation in the study with signature on Informed Consent Form (ICF) prior to specific protocol procedures
Patients of any race
On outpatient treatment
History of frequent symptom crises related to GERD within the last 3 months (at least a frequency of twice a week, for about four to eight weeks)
Diagnosis of erosive esophagitis (grade A to D, according to Los Angeles Classification)
In good health condition, except GERD symptoms
Able to follow the protocol directions and to complete daily the questionnaire ReQuest™ throughout the study

Exclusion criteria

Gastrointestinal disorder, even when related to chlorhydropeptic disorders: Barret's esophagus, peptic ulcer, Zollinger-Ellison syndrome and pyloric stenosis
Previous history of surgery to reduce acid secretion, or other upper gastrointestinal tract surgeries (excepting polypectomy and cholecystectomy)
At initial endoscopy presenting complicated disorders due to erosive esophagitis: obstructive esophageal stenoses, Schatzki ring, esophageal diverticulum, esophageal varices, achalasia and hiatal hernia
Pregnant women or during nursing period
Proton Pump Inhibitors (PPIs) within the last 10 days prior to start of the study
Triple therapy based on PPIs to eradicate H. pylori within the last 28 days prior to start of the study
H2-blockers, sucralfate and prokinetics within the last 7 days prior to start of the study
Systemic glucocorticoids and/or nonsteroidal anti-inflammatory drugs (including COX-2 inhibitors) for more than 3 consecutive days a week, within the last 28 days prior to start of study, with exception of regular intake of acetyl salicylic acid in dosages of up to 163 mg/day.