NCT02277886

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2014

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 19, 2014

Status Verified

November 1, 2014

Enrollment Period

1.6 years

First QC Date

October 2, 2014

Last Update Submit

November 18, 2014

Conditions

Gastroesophageal Reflux DiseaseHeartburnSleep Disturbance

Keywords

sodium alginateesomeprazoleGERD

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with relief of nighttime heartburn (or acid regurgitation)

    the last 7 days of study

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Other Outcomes (1)

  • Incidence of adverse events

    the 28 days treatment period

Study Arms (2)

Alginos plus Nexium

EXPERIMENTAL

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

Drug: sodium alginateDrug: esomeprazole

Nexium alone

ACTIVE COMPARATOR

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

Drug: esomeprazole

Interventions

sodium alginateDRUG

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

Also known as: Alginos
Alginos plus Nexium
esomeprazoleDRUG

40mg/tablet, one tablet once before breakfast

Also known as: Nexium
Alginos plus NexiumNexium alone

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, Taiwan, 105, Taiwan

RECRUITING

MeSH Terms

Conditions

Gastroesophageal RefluxHeartburnParasomnias

Interventions

AlginatesEsomeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

PolysaccharidesCarbohydratesOmeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Cheng-Tang Chiu, M.D.

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng-Tang Chiu, M.D.

CONTACT

+886-3-3281200ctchiu@adm.cgmh.org.tw

Johnny Chu, Ph.D.

CONTACT

+886-2-25090464johnnychu@tty.com.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Director, Department of Internal Medicine

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 29, 2014

Study Start

November 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 19, 2014

Record last verified: 2014-11

Locations

TW(1)