Clinical trial NCT02277886: Esomeprazole Plus Alginate vs. Esomeprazole Alone for Treatment of Nighttime Reflux Symptom and Sleep Disturbances
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Gastroesophageal Reflux Disease
Heartburn
Sleep Disturbance
Keywords: sodium alginate
esomeprazole
GERD
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: TTY Biopharm
First posted: 2014-10-29
Enrollment: 340
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Percentage of patients with relief of nighttime heartburn (or acid regurgitation)
timeFrame: the last 7 days of study
Secondary outcomes:
measure: Percentage of patients with complete resolution of nighttime heartburn (or regurgitation)
timeFrame: the last 7 days of study
measure: Percentage of Patients with relief of GERD-related sleep disturbance
timeFrame: the last 7 days of study
measure: Percentage of Patients with complete resolution of GERD-related sleep disturbance
timeFrame: the last 7 days of study
measure: The percentage of nights without nighttime heartburn (or regurgitation) over treatment period
timeFrame: the 28 days treatment period
measure: Change from baseline of the Pittsburgh Sleep Quality Index questionnaire total score (global PSQI score) at the end of study
timeFrame: the 28 days treatment period
measure: 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)
timeFrame: 28 days after treatment stop
Other outcomes:
measure: Incidence of adverse events
timeFrame: the 28 days treatment period
Locations:
city: Taipei
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Cheng-Tang Chiu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: