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

Last updated: June 24, 2012
Sponsor: Takeda
Overall Status: Completed

Phase

3

Condition

Esophageal Disorders

Gastroesophageal Reflux Disease (Gerd)

Heartburn (Pediatric)

Treatment

N/A

Clinical Study ID

NCT01132638
PZ-9999-401-BR
U1111-1130-9255
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 leasta frequency of twice a week, for about four to eight weeks)

  • Diagnosis of erosive esophagitis (grade A to D, according to Los AngelesClassification)

  • In good health condition, except GERD symptoms

  • Able to follow the protocol directions and to complete daily the questionnaireReQuest™ throughout the study

Exclusion

Exclusion Criteria:

  • Gastrointestinal disorder, even when related to chlorhydropeptic disorders: Barret'sesophagus, peptic ulcer, Zollinger-Ellison syndrome and pyloric stenosis

  • Previous history of surgery to reduce acid secretion, or other upper gastrointestinaltract surgeries (excepting polypectomy and cholecystectomy)

  • At initial endoscopy presenting complicated disorders due to erosive esophagitis:obstructive esophageal stenoses, Schatzki ring, esophageal diverticulum, esophagealvarices, 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 tostart of the study

  • H2-blockers, sucralfate and prokinetics within the last 7 days prior to start of thestudy

  • Systemic glucocorticoids and/or nonsteroidal anti-inflammatory drugs (including COX-2inhibitors) for more than 3 consecutive days a week, within the last 28 days prior tostart of study, with exception of regular intake of acetyl salicylic acid in dosagesof up to 163 mg/day.

Study Design

Total Participants: 713
Study Start date:
August 01, 2011
Estimated Completion Date:
June 30, 2012

Connect with a study center

  • Investigational site

    Belo Horizonte/MG,
    Brazil

    Site Not Available

  • Investigational site

    Curitiba/PR,
    Brazil

    Site Not Available

  • Investigational site

    Goiânia/GO,
    Brazil

    Site Not Available

  • Investigational site

    Goiânia/GO,
    Brazil

    Site Not Available

  • Investigational site

    Porto Alegre/RS,
    Brazil

    Site Not Available

  • Investigational site

    Ribeirão Preto/SP,
    Brazil

    Site Not Available

  • Investigational site

    Ribeirão Preto/SP,
    Brazil

    Site Not Available

  • Investigational site

    Rio de Janeiro/RJ,
    Brazil

    Site Not Available

  • Investigational site

    Salvador/BA,
    Brazil

    Site Not Available

  • Investigational site

    Santo André/SP,
    Brazil

    Site Not Available

  • Investigational site

    Santo André/SP,
    Brazil

    Site Not Available

  • Investigational site

    São Paulo/SP,
    Brazil

    Site Not Available

  • Investigational site

    São Paulo/SP,
    Brazil

    Site Not Available

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