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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01132638
First received: May 21, 2010
Last updated: June 24, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
GERD
Drug: Magnesium Pantoprazole
Drug: Magnesium Esomeprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Takeda:

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. [ Time Frame: After 4 treatment weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: After 4 and 8 treatment weeks ] [ Designated as safety issue: No ]
  • Treatments comparative evaluation for the time interval from treatment start to the beginning of symptoms relief [ Designated as safety issue: No ]
  • Treatments comparative evaluation for endoscopic healing rate [ Time Frame: After 4 and 8 treatment weeks ] [ Designated as safety issue: No ]

Enrollment: 713
Study Start Date: August 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01132638

Locations
Brazil
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
Sponsors and Collaborators
Takeda
  More Information

No publications provided by Takeda

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01132638     History of Changes
Other Study ID Numbers: PZ-9999-401-BR, U1111-1130-9255
Study First Received: May 21, 2010
Last Updated: June 24, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Takeda:
Gastroesophageal
Pantoprazole
erosive
Erosive GERD grades A-D, acc. to Los Angeles classification

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pantoprazole
Omeprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014