Non-erosive Reflux Disease
Conditions
Brief summary
The purpose of this study is to investigate the pharmacodynamic effect of omeprazole n a Japanese non-erosive reflux disease population
Interventions
DRUGOmeprazole
Sponsors
Tanabe Pharma Corporation
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who identified their predominant symptom as heartburn and were classifiend as Grande M or N according to Hoshihara's modofied version of Los Angeles Classification at esophagogastroduodenoscopy. Written informed consent, ability to comply with study instructions
Exclusion criteria
* Patients with any ongoing gastrointestinal bleeding at the time of esopgahogastroduodenoscopy, patients with any history of erosive esophagitis or any other major diseases or concommittant drugs likely to interfere with the evaluation of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the pharmacodynamic effect of omeprazole 10mg and 20mg od in patients with NERD, by assessment of the change of the percentage of time with intra-esophageal pH <4 during 24 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the relation between pharmacodynamic effect and GERD symptoms,to investigate safety | — |
Countries
Japan
Outcome results
None listed