The aim of the present study is to identify factors (such as symptom patterns and symptom scores) that influence the response to treatment with pantoprazole using different evaluation methods (e.g. ‘ReQuest’ questionnaire, patient and investigator assessment). Pantoprazole will be administered once daily in the morning at one dose level. The study duration consists of a treatment period of 8 weeks. The study will provide further data on safety and tolerability of pantoprazole.
Official Title
Real Life: Treatment Response in Patients With Symptoms Due to Gastroesophageal Reflux Disease Either With or Without Esophagitis Treated With Pantoprazole Sodium 40 mg o.d. Over 8 Weeks
Conditions
Gastroesophageal Reflux Disease (GERD)
Study Type
Interventional
Study Design
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Further Details
Primary Outcome Measures:
- Response to treatment with pantoprazole at week 8, as measured by the questionnaire ‘ReQuest’.
Secondary Outcome Measures:
- Response to treatment with pantoprazole at week 4, as measured by the questionnaire ‘ReQuest’
- Investigator assessment
- Safety and efficacy.
Study Start
May 2006
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and above
- Genders Eligible for Study: Both
Inclusion Criteria:
- Written informed consent
- Outpatients of at least 18 years
- Patient considered to have GERD symptoms
Exclusion Criteria:
- Acute peptic ulcer and/or ulcer complications
- Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (> 5 days on demand but not more than 3 consecutive days) during the last 28 days before study start (except regular intake of acetylsalicylic acid at a dose up to 163 mg/day)
- Intake of proton pump inhibitors during the last 10 days before study start
- Female patients of childbearing potential not using adequate means of birth control
- Pregnant or breast-feeding females
Total Enrolment
2000
Contact Details
For more information about this trial, contact Nycomed Australia
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