The CONQUEST-Study. Evaluation of Clinical Endpoints for Treatment-induced Changes in GERD-related Symptoms (BY1023/NL511)

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Pantoprazole

Criteria

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