A Phase 3 interventional study of Sodium alginate and Omeprazole in Gastroesophageal Reflux Disease and Heartburn, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-02-10.
Sponsored by Chang Gung Memorial Hospital · Phase 3, Interventional, and Treatment
About 60% of patients with typical gastroesophageal reflux symptoms such as heartburn and regurgitation are considered to have non-erosive reflux disease (NERD). Patients with NERD show an overall poorer response to PPI treatment than patients with erosive reflux disease. Sodium alginate oral suspension is a medication indicated for the relief of gastroesophageal reflux symptoms. This multi-center, double blind, randomized trial aims to compare the efficacy and safety profiles of sodium alginate oral suspension (50 mg/ml) 20 ml three times daily with that of omeprazole (20 mg/capsule) 1 capsule once daily for the treatment of NERD patients in Taiwan. Efficacy assessments include percentage of patients achieving adequate relief of heartburn or regurgitation after 4 weeks treatment, improvement of reflux symptoms as assessed by reflux disease questionnaire before and after treatment, and patients overall satisfaction at the end of study. Safety assessments include incidence of adverse events and change of the laboratory test results. The study hypothesis is that treatment with sodium alginate is non-inferior to omeprazole in relieving heartburn or regurgitation symptoms of the NERD patients.
This multi-center, double blind, randomized trial aims to compared the efficacy and safety profiles of sodium alginate oral suspension (50 mg/ml) 20 ml three times daily with that of omeprazole (20 mg/capsule) 1 capsule once daily for the treatment of non-erosive reflux disease (NERD) patients in Taiwan. Patients will be included into study if they are diagnosed as NERD; with heartburn or regurgitation (either one) as main symptom at least 2 days a week and had been present for ≧1 month before screening; with heartburn or regurgitation (either one) during the 7 days screening period, either with frequency for ≧4 days of mild symptom, or ≧ 2 days of moderate to severe symptom; and have signed the informed consent. Patients will be excluded if they are diagnosed as erosive gastroesophageal reflux disease (GERD), Barrett's esophagus or esophageal stricture; with active or healing gastroduodenal ulcer (except scars); with history of gastric, duodenal or esophageal surgery; with intrahepatic stone, gallstone, gallbladder sludge, hepatic or pancreatic carcinoma as evidenced by abdominal ultrasonography, with ischemic heart disease as evidenced by electrocardiogram; taking a proton pump inhibitor (PPI) within 14 days before screening, or a H2-blocker, prokinetic agent or antacid within 7 days before screening; or with clinically significant liver or kidney disease. The primary efficacy endpoint is percentage of patients achieving adequate heartburn (defined as a burning feeling or pain behind the breast bone) or regurgitation (defined as an acid taste in the mouth or unpleasant movement of material upwards from the stomach) relief at day 28 as assessed by patient diary. The secondary efficacy endpoints are percentage of patients achieving adequate heartburn or regurgitation relief at day 14; change from baseline of the reflux disease questionnaire total score at day 14 \& 28; patients' overall satisfaction at the end of study; and number of antacid used during the 4-week treatment period. The safety endpoints are incidence of adverse events, and changes in laboratory test results (hematology, biochemistry, and urinalysis). The study hypothesis is that treatment with sodium alginate is non-inferior to omeprazole in relieving heartburn or regurgitation symptoms of the NERD patients.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 195 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
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Exclusion Criteria:
Oral suspension, 50 mg/ml
Drug: Sodium alginate
20 mg/cap
Drug: Omeprazole
oral suspension, 50 mg/ml, 20 ml three times daily, 4 weeks
Also known as: Alginos
20 mg capsule, 1 capsule once daily, 4 weeks
Also known as: Omelon
Percentage of patients achieving adequate heartburn or regurgitation relief at day 28 as assessed by patient diary
Adequate heartburn or regurgitation relief is defined as no more than 1 day of mild heartburn or regurgitation episodes in the last 7 days before day 28
Time frame: 4 weeks
Percentage of patients achieving adequate heartburn or regurgitation relief at day 14 as assessed by patient diar
Adequate heartburn or regurgitation relief is defined as no more than 1 day of mild heartburn or regurgitation episodes in the last 7 days before day 14
Time frame: 2 weeks
Change from baseline of the Reflux Disease Questionnaire (RDQ) total score at days 14 & 28
RDQ is a 12-item self-administered questionnaire and there are 3 subscales that evaluate frequency and severity of heartburn, regurgitation and dyspepsia. Each item is scored on a 6-point Likert scale ranging from 0 to 5. The RDQ total scores are determined by the sum of 12-item scores.
Time frame: 2 and 4 weeks
Patients' overall satisfaction at the end of study
The overall satisfaction is categorized as:0=very poor; 1=poor; 2=unsatisfactory; 3=satisfactory; 4=good; 5=very good
Time frame: 4 weeks
Number of antacid used during the treatment period
Time frame: 4 weeks
This study is completed, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital