Gastroesophageal Reflux Disease
Conditions
Brief summary
Rapid onset of proton-pump inhibitors to achieve a fast symptom is an unmet need in treating gastroesophageal reflux disease (GERD) but there was no report on the short-term clinical effects and timing to symptom relief comparing dexlansoprazole 60 mg to esomeprazole 40 mg. This pilot study aims to compare the one-week clinical effects of single doses of the two drugs in treating GERD patients.
Detailed description
A comparative study to different PPIs in pharmacokinetic change showing that after 12-24 hours post dose, mean percentage of time with pH \> 4 and average of mean pH were greater for dexlansoprazole than esomeprazole . However, the study did not report the clinical effect after tablets used. There was no report on the short-term clinical effects and timing to symptom relief of gastroesophageal reflux disease (GERD) between dexlansoprazole 60 mg and esomeprazole 40 mg. Therefore, we conducted a randomized controlled, open-label, study to compare the 7-day clinical effects of single doses of dexlansoprazole 60 mg and esomeprazole 40 mg in for GERD.
Interventions
DRUGEsomeprazole group
Esomeprazole 40mg qd
Dexlansoprazole 60mg qd
Sponsors
Kaohsiung Medical University Chung-Ho Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with clinical symptoms of acid regurgitation, heart burn, or feeling of acidity in the stomach, who have Los Angeles Grade A and B erosive esophagitis proven by endoscopy were recruited
Exclusion criteria
* taking antisecretory agents, such as PPIs and histamine-2 receptor antagonists within 2 week prior to the endoscopy * coexistence of peptic ulcer or gastrointestinal malignancies * pregnancy * coexistence of serious concomitant illness (for example, decompensated liver cirrhosis and uremia), * previous gastric surgery * allergy to dexlansoprazole or esomeprazole * symptom score of a validated questionnaire (Chinese GERDQ) less than 12
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complete symptom resolution (CSR) | 1 week after finishing study drug | Evaluate the complete symptom resolution by questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of symptom relapse | 12 weeks after finishing study drug | Symptom relapse is defined as (a) two or more episodes of reflux symptoms per week that impair the quality of life |
Outcome results
None listed