Efficacy and Safety of Sodium Alginate Oral Suspension to Treat Non-erosive Gastro-esophageal Ref… (NCT01338077) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Sodium Alginate Oral Suspension to Treat Non-erosive Gastro-esophageal Reflux Disease
Taiwan195 participantsStarted 2010-10
Plain-language summary
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.
Who can participate
Age range
20 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with age of 20-75 years old (inclusive) in Taiwan of both genders
* Out-patients who had been diagnosed as non-erosive gastroesophageal reflux disease (NERD)
* Patients with heartburn or regurgitation (either one) as main symptom at least 2 days a week and had been present for \> or = 1 month before screening
* Patients with heartburn or regurgitation (either one) during the 7 days screening period, either with frequency for \> or = 4 days of mild symptom, or for \> or = 2 days of moderate to severe symptom
* Patients have signed the informed consent form
Exclusion Criteria:
* Patients with erosive gastroesophageal reflux disease (GERD), Barrett's esophagus or esophageal stricture
* Patients with active or healing gastroduodenal ulcer (except scars)
* Patients with history of gastric, duodenal or esophageal surgery
* Patients with malignant disease of any kind
* Patients with intrahepatic stone, gallstone, gallbladder sludge, hepatic or pancreatic carcinoma as evidenced by abdominal ultrasonography
* Patients with ischemic heart disease as evidenced by electrocardiogram
* Female patients who are pregnant or nursing mother
* Patients with a history of allergy to any of the study drugs or their related compounds
* Patients with a history of alcohol or drug abuse
* Patients with clinically significant liver disease (aspartate aminotransferase (AST), alanine aminotransferase (ALT)\>2 upper limits of normal)
* Patients with clinically significant …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of patients achieving adequate heartburn or regurgitation relief at day 28 as assessed by patient diary