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

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02277886

Collaborator

TTY Biopharm (Industry)

340

Enrollment

Location

Arms

Duration (Months)

17.9

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Gastroesophageal Reflux Disease Heartburn Sleep Disturbance	Drug: sodium alginate Drug: esomeprazole	Phase 4

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 tablet once daily for the treatment of erosive GERD patients in Taiwan. Patients will be enrolled into study if they are diagnosed as GERD (grade A~D); with history of heartburn (or regurgitation) for ≥ 3 months before entering study; with history of GERD-related sleep disturbances for ≥ 1 month before entering study; with nighttime heartburn (or regurgitation) graded as moderate, or severe, on ≥ 3 nights in the last 7 days of screening period; with GERD-related sleep disturbances on ≥ 3 nights in the last 7 days of screening period; with the global PSQI score >5; and have signed the informed consent. Patients will be excluded if they are diagnosed as non-erosive GERD, Barrett's esophagus or esophageal stricture; with any conditions other than GERD that could be the primary cause of sleep disturbance; with active esophageal, gastric or duodenal ulcers; with history of esophageal, gastric or duodenal surgery; with active cancers of any kind; female patients who are pregnant or lactating; who were allergy to any of the study drugs; taking a proton pump inhibitor (PPI) within 7 days, or any prokinetic agent, H2-blocker, alginate preparations or antacid within 2 days before screening; with a history of drug addiction or alcohol abuse within the past 12 months; or with any other conditions or diseases that investigator considers it is not appropriate to enter the study. The primary efficacy endpoint is the percentage of patients with relief of nighttime heartburn (or acid regurgitation). The secondary efficacy endpoints are percentage of patients with complete resolution of nighttime heartburn (or regurgitation); percentage of patients with relief of GERD-related sleep disturbance; percentage of patients with complete resolution of GERD-related sleep disturbance; percentage of nights without nighttime heartburn (or regurgitation) over treatment period; change from baseline of the Pittsburgh Sleep Quality Index questionnaire total score (global PSQI score) at the end of study; and change of the percentage of patients with relief of nighttime heartburn (or acid regurgitation) at post-treatment visit (V4) as compared to final visit (V3) in test group (Nexium plus Alginos). The safety endpoint is incidence of adverse events. This study aims to prove that sodium alginate plus esomeprazole is superior to esomeprazole alone in relieving nighttime reflux symptoms and sleep disturbance in erosive GERD patients.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

340 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Clinical Trial: Esomeprazole Plus Alginate vs. Esomeprazole Alone for Treatment of Nighttime Reflux Symptom and GERD-related Sleep Disturbances in Patients With Erosive GERD

Study Start Date :

Nov 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2016

Anticipated Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alginos plus Nexium sodium alginate 20ml (50mg/ml) once at bed time, and esomeprazole (40mg/tablet) 1 tablet once before breakfast, 4 weeks	Drug: sodium alginate oral suspension, 50mg/ml, 20ml once at bed time Other Names: Alginos Drug: esomeprazole 40mg/tablet, one tablet once before breakfast Other Names: Nexium
Active Comparator: Nexium alone esomeprazole (40mg/tablet) 1 tablet once before breakfast, 4 weeks	Drug: esomeprazole 40mg/tablet, one tablet once before breakfast Other Names: Nexium

Arm

Intervention/Treatment

Experimental: Alginos plus Nexium

sodium alginate 20ml (50mg/ml) once at bed time, and esomeprazole (40mg/tablet) 1 tablet once before breakfast, 4 weeks

Drug: sodium alginate

oral suspension, 50mg/ml, 20ml once at bed time

Other Names:

Alginos

Drug: esomeprazole

40mg/tablet, one tablet once before breakfast

Other Names:

Nexium

Active Comparator: Nexium alone

esomeprazole (40mg/tablet) 1 tablet once before breakfast, 4 weeks

Drug: esomeprazole

40mg/tablet, one tablet once before breakfast

Other Names:

Nexium

Outcome Measures

Primary Outcome Measures

Percentage of patients with relief of nighttime heartburn (or acid regurgitation) [the last 7 days of study]

Secondary Outcome Measures

Percentage of patients with complete resolution of nighttime heartburn (or regurgitation) [the last 7 days of study]
Percentage of Patients with relief of GERD-related sleep disturbance [the last 7 days of study]
Percentage of Patients with complete resolution of GERD-related sleep disturbance [the last 7 days of study]
The percentage of nights without nighttime heartburn (or regurgitation) over treatment period [the 28 days treatment period]
Change from baseline of the Pittsburgh Sleep Quality Index questionnaire total score (global PSQI score) at the end of study [the 28 days treatment period]
Change of the percentage of patients with relief of nighttime heartburn (or acid regurgitation) at post-treatment visit (V4) as compared to final visit (V3) in test group (Nexium plus Alginos) [28 days after treatment stop]

Other Outcome Measures

Incidence of adverse events [the 28 days treatment period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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