Heartburn acid regurgitation NERD nonerosive esophageal reflux disease Heartburn acid regurgitation NERD nonerosive esophageal reflux disease
Conditions
Interventions
Sponsors
Faculty of Medicine Siriraj Hospital, Mahidol University
The Gastroenterological Association of Thailand
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Adult patients (age at least 18 years old) who non-responsive to omeprazole 20 mg once daily were eligible for enrollment in the trial. Non-responsive NERD defined as less than 50% improvement of heartburn or acid regurgitation for 1 days per week during the 30 days before screening while taking omeprazole 20 mg once daily. All patients were performed esophagogastroduodenoscopy that showed no lesion at esophagogastric junction.
Exclusion criteria
Exclusion criteria: Exclusion criteria included current or historical evidence of esophageal ulcers or strictures, gastric or duodenal ulcers or any other gastric or esophageal pathology judged to be clinically significant by the investigator, significant gastric or esophageal pathology, motility disorder (eg, achalasia, scleroderma, autonomic neuropathy, peripheral neuropathy or myopathy), Active Helicobacter pylori infection. Also excluded were patients who received concurrent medications that interfered esophageal or gastric motility and also gastric pH were excluded, these drug such as NSAIDs, ASA, bisphosphonate, theophylline, bismuth salts, warfarin, phenytoin, barbiturates, antineoplastic agents, erythromycin, clarithromycin, or sucralfate. Patients who experienced history of drug allergy or side effect of proton pump inhibitors. Women were required to be nonpregnant, nonlactating, and using a medically acceptable form of birth control.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of patients with symptoms free at last week of treatment fourth week percentage of patients with symptoms free at last week of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of heartburn-free days 4 weeks Percentage of heartburn-free days ,Percentage of nighttime heartburn-free days 4 weeks Percentage of nighttime heartburn-free days,Percentage of Acid regurgitation-free days 4 week Percentage of Acid regurgitation-free days,Percentage of patients with Symptom improvement 4 weeks Percentage of patients with Symptom improvement,supplemental antacid usage 4 weeks supplemental antacid usage,quality of life 2 and 4 weeks GERD-QOL score | — |
Countries
Thailand
Contacts
Public ContactDeuanpen Kanjanawatta
Siriraj Hospital
Outcome results
None listed