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
2 other identifiers
interventional
713
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2011
Shorter than P25 for phase_3
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2010
CompletedFirst Posted
Study publicly available on registry
May 28, 2010
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedJune 26, 2012
June 1, 2012
10 months
May 21, 2010
June 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
Magnesium Pantoprazole
ACTIVE COMPARATORMagnesium Esomeprazole
ACTIVE COMPARATORInterventions
1 capsule daily, 40 mg, orally, 30 minutes before breakfast
1 capsule daily, 40 mg, orally, 30 minutes before breakfast
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (9)
Investigational site
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
Related Publications (1)
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.
PMID: 24299323DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2010
First Posted
May 28, 2010
Study Start
August 1, 2011
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
June 26, 2012
Record last verified: 2012-06