Gastroesophageal Reflux Disease (GERD)
Conditions
Keywords
Gastroesophageal Reflux Disease, GERD, Pantoprazole, ReQuestTM
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.
Interventions
DRUGPantoprazole
Pantoprazole 40 mg o.d.
Sponsors
Takeda
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to treatment with pantoprazole at week 8, as measured by the questionnaire ReQuest™ | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Hong Kong, India, Italy, Malaysia, Mexico, Poland, Portugal, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, United Kingdom
Outcome results
None listed