Gastroesophageal Reflux, GERD, GORD
Conditions
Keywords
Gastroesophageal Reflux, Gastroesophageal Reflux Disease, Pantoprazole
Brief summary
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks back (refluxes) into the esophagus. GERD is one of the most common medical disorders, with estimates of up to 50% of adults reporting reflux symptoms. Proton pump inhibitors such as pantoprazole, can relieve symptoms of GERD in a large proportion of patients. Of particular interest in GERD is the assessment of symptom severity and quality of life, and the response to treatment. Therefore, a questionnaire was developed to assess GERD symptoms ('ReQuest TradeMark in Practice'). An important point to consider when using such a questionnaire is to follow the patients´ medical response to treatment and note whether a patient needs to change dosing, such as changing from full dose to half dose, or vice versa. The aim of the study is to determine the value of the questionnaire ('ReQuest TradeMark in Practice') according to treating physicians' clinical judgment when using pantoprazole at full and half dose. The study duration consists of a pre-treatment periods (0-2 weeks) and two treatment period (8 weeks each). During the first treatment period, pantoprazole will be administered once daily at full dose (40 mg). During the second treatment period, pantoprazole will be administered once daily at half dose (20 mg). The study will provide further data on safety and tolerability of pantoprazole.
Interventions
DRUGPantoprazole
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 of age * GERD * Patients with symptoms of GERD Main
Exclusion criteria
* Signs, indicating other gastrointestinal diseases * Other concomitant diseases * Special restrictions for female patients * Previous medication * Concomitant medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GERD symptom score after 8 weeks of treatment (prior to stepping down from full dose to half dose) for patients not being symptomatically relieved from GERD after 16 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| symptom status (compared with pre-treatment) | — |
| time to reach first relief from reflux disease related symptoms | — |
| time to reach sustained symptom relief | — |
| Symptom relief rates | — |
| influence of the H. pylori-status on the symptom relief rates | — |
| safety. | — |
| relief rates from reflux disease related complaints | — |
Countries
United Kingdom
Outcome results
None listed