Official Title: “The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-Induced Changes in GERD-Related Symptoms”

The aim of the study is to compare two different endpoint measures: heartburn as assessed by the physicians versus gastroesophageal reflux disease (GERD)-related symptoms as assessed by the patient using the ReQuest™ questionnaire. The assessment is made in GERD-patients treated with a daily dose of 40 mg oral pantoprazole over an 8-week period.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Study Primary Completion Date: October 2007

Intervention(s) in this Clinical Trial

• Drug: Pantoprazole
  • 40 mg Pantoprazole

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1.
  • 40 mg Pantoprazole

Primary Measures

• Rate of misclassification on day 14 based on heartburn as assessed by the investigator compared to symptom assessment by the patient using the ReQuest™-gastrointestinal (GI) questionnaire
  • Time Frame: 8 weeks
    Safety Issue?: No

Secondary Measures

• Rate of misclassification on day 14 based on acid regurgitation as assessed by the investigator compared to symptom assessment by the patient using the ReQuest™-GI questionnaire
  • Time Frame: 8 weeks
    Safety Issue?: No

Inclusion Criteria:

• Written informed consent
• Outpatients of at least 18 years of age
• History of GERD-related symptoms of at least 6 months prior to baseline visit
• Endoscopically-confirmed GERD or non-erosive GERD

Exclusion Criteria:

• Zollinger-Ellison syndrome or other gastric hypersecretory condition
• Acute peptic ulcer and/or ulcer complications
• Pyloric stenosis
• Severe or unstable cardiovascular, pulmonary, and/or endocrine disease
• Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of reliable contraception in women of child-bearing potential
• Intake of any medication for the purpose of eradication of Helicobacter pylori (H.
• pylori) within the last 28 days prior to study start
• Intake of systemic glucocorticoids or non-steroidal anti-inflammatory drugs including cyclooxygenase-2 (COX-2) inhibitors for more than 3 consecutive days within the last 28 days prior to study start; with the exception of acetylsalicylic acid not more than 150 mg per day

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: ALTANA Pharma

Overall Clinical Trial Officials and Contacts

M. Oudkerk Pool, Prof. Principal Investigator Isala Klieniken, Zwolle, The Netherlands  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00449813

Study ID Number: BY1023/NL511

ClinicalTrials.gov Identifier: NCT00449813

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)