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NCT Number: NCT00325676

Comparison of the Classical Healing Concept With the Complete Remission Concept After Treatment With Pantoprazole in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) (BY1023/M3-342)

The aim of this study is to evaluate the complete remission rates, endoscopic relapses, study discontinuation rates, and quality of life parameters in patients with erosive GERD. The study duration consists of a treatment period up to 16 weeks according to the classical healing concept or the complete remission concept. During this period, the patients will receive pantoprazole (tablet) at one dose level once daily. The following observational phase lasts up to 6 months. The study will provide further data on efficacy, safety, and tolerability of pantoprazole.

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Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Disease Attributes Disease Progression Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Pathologic Complete Response Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Altana Pharma/Nycomed, Belo Horizonte-MG, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Written informed consent
  • Endoscopically confirmed GERD (Los Angeles classification A-D)
  • Patients whose compliance is expected to be high with respect to the completion of the questionnaires

Main Exclusion Criteria:

  • Other gastrointestinal diseases
  • Severe concomitant diseases
  • Proton pump inhibitors (PPIs) during last 14 days before start
  • H2 receptor antagonists, prokinetics during last 7 days before study start
  • Helicobacter pylori (H. pylori) eradication during last 28 days before study start

Treatment and study plan

Pantoprazole

Drug

Primary outcomes

  1. time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms

Secondary outcomes

  1. further efficacy criteria

  2. safety

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

CONFIRM - Confirmation of Superiority of Complete Remission Concept Versus Classical Healing Concept for Treatment of Patients With Erosive GERD

Important dates

Study start
2006
First posted
May 15, 2006
Registry last updated
May 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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