Status:
UNKNOWN
Esomeprazole Plus Alginate vs. Esomeprazole Alone for Treatment of Nighttime Reflux Symptom and Sleep Disturbances
Lead Sponsor:
Chang Gung Memorial Hospital
Collaborating Sponsors:
TTY Biopharm
Conditions:
Gastroesophageal Reflux Disease
Heartburn
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
Brief Summary
Among those patients experienced GERD symptoms, up to 89% report nocturnal symptoms, resulting in poor sleep quality. Sodium alginate oral suspension (Alginos) is a medication indicated for the relief...
Detailed Description
This multi-center, open-label, randomized trial aims to compared the efficacy and safety profiles of sodium alginate oral suspension (50mg/ml) 20ml at bedtime with that of esomeprazole (40mg/tablet) 1...
Eligibility Criteria
Inclusion
- Out -patients with age of 20-80 years old (inclusive) in Taiwan of both genders
- 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
- Patients with non-erosive GERD, Barrett's esophagus or esophageal stricture
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT02277886
Start Date
November 1 2014
End Date
June 1 2016
Last Update
November 19 2014
Active Locations (1)
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1
Chang Gung Memorial Hospital
Taipei, Taiwan, Taiwan, 105