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

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ClinicalTrials.gov Identifier: NCT02277886
Recruitment Status : Unknown
Verified November 2014 by Cheng-Tang Chiu, Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : October 29, 2014
Last Update Posted : November 19, 2014
Sponsor:
Collaborator:
TTY Biopharm
Information provided by (Responsible Party):
Cheng-Tang Chiu, Chang Gung Memorial Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2014
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


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 Name: Alginos

Drug: esomeprazole
40mg/tablet, one tablet once before breakfast
Other Name: 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 Name: Nexium




Primary Outcome Measures :
  1. Percentage of patients with relief of nighttime heartburn (or acid regurgitation) [ Time Frame: the last 7 days of study ]

Secondary Outcome Measures :
  1. Percentage of patients with complete resolution of nighttime heartburn (or regurgitation) [ Time Frame: the last 7 days of study ]
  2. Percentage of Patients with relief of GERD-related sleep disturbance [ Time Frame: the last 7 days of study ]
  3. Percentage of Patients with complete resolution of GERD-related sleep disturbance [ Time Frame: the last 7 days of study ]
  4. The percentage of nights without nighttime heartburn (or regurgitation) over treatment period [ Time Frame: the 28 days treatment period ]
  5. Change from baseline of the Pittsburgh Sleep Quality Index questionnaire total score (global PSQI score) at the end of study [ Time Frame: the 28 days treatment period ]
  6. 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) [ Time Frame: 28 days after treatment stop ]

Other Outcome Measures:
  1. Incidence of adverse events [ Time Frame: the 28 days treatment period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02277886


Contacts
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Contact: Cheng-Tang Chiu, M.D. +886-3-3281200 ext 8102 ctchiu@adm.cgmh.org.tw
Contact: Johnny Chu, Ph.D. +886-2-25090464 ext 4280 johnnychu@tty.com.tw

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taipei, Taiwan, 105
Contact: Cheng-Tang Chiu, MD    +886-3-3281200 ext 8101    stacey@adm.cgmh.org.tw   
Contact: Johnny Chu, PhD    +886-2-25090464 ext 4280    johnnychu@tty.com.tw   
Principal Investigator: Cheng-Tang Chiu, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
TTY Biopharm
Investigators
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Principal Investigator: Cheng-Tang Chiu, M.D. Chang Gung Memorial Hospital

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Responsible Party: Cheng-Tang Chiu, Vice Director, Department of Internal Medicine, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02277886     History of Changes
Other Study ID Numbers: ALG-NR-14
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014
Keywords provided by Cheng-Tang Chiu, Chang Gung Memorial Hospital:
sodium alginate
esomeprazole
GERD
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Dyssomnias
Sleep Wake Disorders
Parasomnias
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action