Esomeprazole Plus Alginate vs. Esomeprazole Alone for Treatment of Nighttime Reflux Symptom and Sleep Disturbances
NCT ID: NCT02277886
Last Updated: 2014-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
340 participants
INTERVENTIONAL
2014-11-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Alginos plus Nexium
sodium alginate 20ml (50mg/ml) once at bed time, and esomeprazole (40mg/tablet) 1 tablet once before breakfast, 4 weeks
sodium alginate
oral suspension, 50mg/ml, 20ml once at bed time
esomeprazole
40mg/tablet, one tablet once before breakfast
Nexium alone
esomeprazole (40mg/tablet) 1 tablet once before breakfast, 4 weeks
esomeprazole
40mg/tablet, one tablet once before breakfast
Interventions
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sodium alginate
oral suspension, 50mg/ml, 20ml once at bed time
esomeprazole
40mg/tablet, one tablet once before breakfast
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who had been previously diagnosed as erosive GERD (i.e. grade A\~D according to the modified Los-Angeles Classification. Endoscopic examination results within 21 days before randomization visit (V2) are acceptable.
* Patients with history of heartburn (or regurgitation) for ≥ 3 months before entering study
* Patients with history of GERD-related sleep disturbances for ≥ 1 month before entering study
* Patients with nighttime heartburn (or regurgitation) graded as moderate, or severe, on ≥ 3 nights in the last 7 days of screening period
* Patients with GERD-related sleep disturbances on ≥ 3 nights in the last 7 days of screening period
* Patients with the global PSQI score \>5
* Patients have signed the informed consent form
Exclusion Criteria
* Patients with any conditions other than GERD that could be the primary cause of sleep disturbance (e.g. sleep apnoea, obstructed airway, severe depression, severe anxiety, panic attacks, chronic obstructive pulmonary disease requiring oxygen therapy)
* Patients with active esophageal, gastric or duodenal ulcers
* Patients with history of esophageal, gastric or duodenal surgery
* Patients with active cancers of any kind
* Female patients who are pregnant or lactating
* Patients who were allergy to any of the study drugs
* Patients taken a proton pump inhibitor (PPI) within 7 days, or any prokinetic agent, H2-blocker, alginate preparations or antacid within 2 days before screening
* Patients with a history of drug addiction or alcohol abuse within the past 12 months
* Patients with any other conditions or diseases that investigator considers it is not appropriate to enter the study
20 Years
80 Years
ALL
No
Sponsors
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TTY Biopharm
INDUSTRY
Chang Gung Memorial Hospital
OTHER
Responsible Party
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Cheng-Tang Chiu
Vice Director, Department of Internal Medicine
Principal Investigators
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Cheng-Tang Chiu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Chang Gung Memorial Hospital
Taipei, Taiwan, Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ALG-NR-14
Identifier Type: -
Identifier Source: org_study_id