A Randomized Controlled Trial of Dexlansoprazole vs. Double Dose Omeprazole in Non-responsive Nonerosive Esophageal Reflux Disease
- Conditions
- Heartburnacid regurgitationNERDnonerosive esophageal reflux diseaseHeartburnacid regurgitationNERDnonerosive esophageal reflux disease
- Registration Number
- TCTR20160517003
- Lead Sponsor
- Faculty of Medicine Siriraj Hospital, Mahidol University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 118
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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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