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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01132638
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : June 26, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
GERD Drug: Magnesium Pantoprazole Drug: Magnesium Esomeprazole Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 713 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : August 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

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

Primary Outcome Measures :
  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. [ Time Frame: After 4 treatment weeks ]
    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 :
  1. Treatments comparative evaluation for DRGE ReQuest™-GI and -WSO scores change with respect to baseline measured [ Time Frame: After 4 and 8 treatment weeks ]
  2. Treatments comparative evaluation for the time interval from treatment start to the beginning of symptoms relief
  3. Treatments comparative evaluation for endoscopic healing rate [ Time Frame: After 4 and 8 treatment weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01132638

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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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Takeda Identifier: NCT01132638    
Other Study ID Numbers: PZ-9999-401-BR
U1111-1130-9255 ( Registry Identifier: WHO )
First Posted: May 28, 2010    Key Record Dates
Last Update Posted: June 26, 2012
Last Verified: June 2012
Keywords provided by Takeda:
Erosive GERD grades A-D, acc. to Los Angeles classification
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action