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

Primary Purpose

GERD

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Magnesium Pantoprazole
Magnesium Esomeprazole
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for GERD focused on measuring Gastroesophageal, Pantoprazole, erosive, Erosive GERD grades A-D, acc. to Los Angeles classification

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Magnesium Pantoprazole

Magnesium Esomeprazole

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Treatments comparative evaluation for DRGE ReQuest™-GI and -WSO scores change with respect to baseline measured
Treatments comparative evaluation for the time interval from treatment start to the beginning of symptoms relief
Treatments comparative evaluation for endoscopic healing rate

Full Information

First Posted
May 21, 2010
Last Updated
June 24, 2012
Sponsor
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT01132638
Brief Title
Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg in Patients With Erosive Gastroesophageal Reflux Disease
Acronym
PAMES 0109
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD
Keywords
Gastroesophageal, Pantoprazole, erosive, Erosive GERD grades A-D, acc. to Los Angeles classification

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
713 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium Pantoprazole
Arm Type
Active Comparator
Arm Title
Magnesium Esomeprazole
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Magnesium Pantoprazole
Intervention Description
1 capsule daily, 40 mg, orally, 30 minutes before breakfast
Intervention Type
Drug
Intervention Name(s)
Magnesium Esomeprazole
Intervention Description
1 capsule daily, 40 mg, orally, 30 minutes before breakfast
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
After 4 treatment weeks
Secondary Outcome Measure Information:
Title
Treatments comparative evaluation for DRGE ReQuest™-GI and -WSO scores change with respect to baseline measured
Time Frame
After 4 and 8 treatment weeks
Title
Treatments comparative evaluation for the time interval from treatment start to the beginning of symptoms relief
Title
Treatments comparative evaluation for endoscopic healing rate
Time Frame
After 4 and 8 treatment weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Investigational site
City
Belo Horizonte/MG
Country
Brazil
Facility Name
Investigational site
City
Curitiba/PR
Country
Brazil
Facility Name
Investigational site
City
Goiânia/GO
Country
Brazil
Facility Name
Investigational site
City
Porto Alegre/RS
Country
Brazil
Facility Name
Investigational site
City
Ribeirão Preto/SP
Country
Brazil
Facility Name
Investigational site
City
Rio de Janeiro/RJ
Country
Brazil
Facility Name
Investigational site
City
Salvador/BA
Country
Brazil
Facility Name
Investigational site
City
Santo André/SP
Country
Brazil
Facility Name
Investigational site
City
São Paulo/SP
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
24299323
Citation
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.
Results Reference
derived

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Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg in Patients With Erosive Gastroesophageal Reflux Disease

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