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Completed

NCT Number: NCT00336219

Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)

The aim of this study is to compare investigator and patient-assessed gastroesophageal reflux disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An endoscopy will be performed at study start and study end. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™ questionnaire). The study duration consists of a baseline period (8 days) and treatment period (28 days). Pantoprazole (tablet) will be administered once daily at one dose level. The study will provide further data on safety and tolerability of pantoprazole.

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Altana Pharma/Nycomed, Bondi Junction, Australia

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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
  • Outpatients
  • History of GERD-related symptoms for at least 6 months prior to study inclusion
  • Endoscopically confirmed erosive GERD or non-erosive GERD

Main Exclusion Criteria:

  • Acute peptic ulcer and/or ulcer complications
  • PPIs during last 7 days prior to study start
  • Systemic glucocorticoids or non-steroidal anti-inflammatory drugs including COX-2 inhibitors during the last 28 days prior to study start; except regular intake of acetylsalicylic acid up to a daily dose of 163 mg/day
  • Intake of PPIs in combination with antibiotics for eradication of H. pylori

Treatment and study plan

Pantoprazole

Drug

Symptom Assessment after treatment with Pantoprozole 40 mg

Primary outcomes

  1. symptom assessment as measured by ReQuest™ questionnaire and investigator.

    Time frame: 28 days

Secondary outcomes

  1. symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigator

    Time frame: 28 days

  2. endoscopic healing after 28 days

    Time frame: 28 days

  3. health-related quality of life after 28 days

    Time frame: 28 days

  4. safety.

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

COMPETITION: Investigation of Clinical Endpoints for Treatment-induced Gastroesophageal Reflux Disease (GERD) Symptom Changes

Important dates

Study start
2006
Primary completion
2006
Study completion
2007
First posted
Jun 13, 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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