Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)
Phase 3
Completed
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Registration Number
- NCT00312806
- Lead Sponsor
- Takeda
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2000
Inclusion Criteria
- Written informed consent
- Outpatients of at least 18 years (21 years in Argentina)
- Patient considered to have GERD symptoms
Main
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™ 8 weeks
- Secondary Outcome Measures
Name Time Method Response to treatment with pantoprazole at week 4, as measured by the questionnaire ReQuest™ 4 and 8 weeks Investigator assessment 4 and 8 weeks Safety and efficacy 4 and 8 weeks
Trial Locations
- Locations (1)
Altana Pharma/Nycomed
🇬🇧Trowbridge, United Kingdom