Esomeprazole Plus Alginate vs. Esomeprazole Alone for Treatment of Nighttime Reflux Symptom and Sleep Disturbances

• Status: Unknown status
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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 of gastroesophageal reflux symptoms. This multi-center, open-label, randomized trial intends to compare the addition of one dose Alginos (50mg/ml, 20ml) at bed time (Nexium plus Alginos), with no additional alginate treatment (Nexium alone), in erosive GERD patients taking Nexium (40mg/tablet) daily for 4 weeks. Efficacy endpoints include percentage of patients with relief or complete resolution of nighttime heartburn (or regurgitation), percentage of patients with relief or complete resolution of GERD-related sleep disturbance, the percentage of nights without nighttime heartburn (or regurgitation) over treatment period, change from baseline of the Pittsburgh Sleep Quality Index (PSQI) questionnaire total score, and change of the percentage of patients with relief of nighttime heartburn (or regurgitation) at post-treatment visit as compared to final visit in test group (Nexium plus Alginos). Safety endpoint is incidence of adverse events. The study hypothesis is that sodium alginate plus esomeprazole is superior to esomeprazole alone in relieving nighttime reflux symptoms and sleep disturbance in erosive GERD patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Collaborator: TTY Biopharm
• Treatments: Alginic acid; Esomeprazole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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