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

Evaluation of Complete Remission of Erosive Gastroesophageal Reflux Disease Following Four-week Treatment With Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg With Eight-week Extension Treatment in Non-responding Patients - Multicenter, National, Prospective, Randomized, Double-blind, Parallel-group, Phase III

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.

Study Overview

• Status: Completed
• Conditions: GERD
• Intervention / Treatment: Drug: Magnesium Pantoprazole; Drug: Magnesium Esomeprazole

• Study Type: Interventional
• Enrollment (Actual): 713
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Belo Horizonte/MG, Brazil
    • Investigational Site
  • Curitiba/PR, Brazil
    • Investigational Site
  • Goiânia/GO, Brazil
    • Investigational Site
  • Porto Alegre/RS, Brazil
    • Investigational Site
  • Ribeirão Preto/SP, Brazil
    • Investigational Site
  • Rio de Janeiro/RJ, Brazil
    • Investigational Site
  • Salvador/BA, Brazil
    • Investigational Site
  • Santo André/SP, Brazil
    • Investigational Site
  • São Paulo/SP, Brazil
    • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Magnesium Pantoprazole	Drug: Magnesium Pantoprazole; 1 capsule daily, 40 mg, orally, 30 minutes before breakfast
Active Comparator: Magnesium Esomeprazole	Drug: Magnesium Esomeprazole; 1 capsule daily, 40 mg, orally, 30 minutes before breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparatively evaluation of the clinical efficacy of pantoprazole magnesium and esomeprazole in the treatment of patients with erosive gastroesophageal reflux disease (GERD), considering the proportion of patients in complete remission.	A patient is considered at complete remission if he/she achieved symptoms relief and confirmed endoscopic healing at treatment end. A patient achieves symptoms relief if Reflux Questionnaire-GI score ((ReQuest™) stays below 1,73 for at least the three last consecutive treatment days, that can occur at visit V2 or visit V3 for those that did not achieve complete remission at V2 and repeated the treatment for 4 weeks more.	After 4 treatment weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatments comparative evaluation for DRGE ReQuest™-GI and -WSO scores change with respect to baseline measured	After 4 and 8 treatment weeks
Treatments comparative evaluation for the time interval from treatment start to the beginning of symptoms relief
Treatments comparative evaluation for endoscopic healing rate	After 4 and 8 treatment weeks

Collaborators and Investigators

• Sponsor: Takeda

Publications and helpful links

General Publications

• Moraes-Filho JP, Pedroso M, Quigley EM; PAMES Study Group. Randomised clinical trial: daily pantoprazole magnesium 40 mg vs. esomeprazole 40 mg for gastro-oesophageal reflux disease, assessed by endoscopy and symptoms. Aliment Pharmacol Ther. 2014 Jan;39(1):47-56. doi: 10.1111/apt.12540. Epub 2013 Oct 29.

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: May 21, 2010
• First Submitted That Met QC Criteria: May 27, 2010
• First Posted (Estimate): May 28, 2010

Study Record Updates

• Last Update Posted (Estimate): June 26, 2012
• Last Update Submitted That Met QC Criteria: June 24, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Pantoprazole; Gastroesophageal; erosive; Erosive GERD grades A-D, acc. to Los Angeles classification
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole; Pantoprazole
• Other Study ID Numbers: PZ-9999-401-BR; U1111-1130-9255 (Registry Identifier: WHO)