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

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

Tracking Information

• First Submitted Date: October 2, 2014
• First Posted Date: October 29, 2014
• Last Update Posted Date: November 19, 2014
• Study Start Date: November 2014
• Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 27, 2014): Percentage of patients with relief of nighttime heartburn (or acid regurgitation) [ Time Frame: the last 7 days of study ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 27, 2014)

• Percentage of patients with complete resolution of nighttime heartburn (or regurgitation) [ Time Frame: the last 7 days of study ]
• Percentage of Patients with relief of GERD-related sleep disturbance [ Time Frame: the last 7 days of study ]
• Percentage of Patients with complete resolution of GERD-related sleep disturbance [ Time Frame: the last 7 days of study ]
• The percentage of nights without nighttime heartburn (or regurgitation) over treatment period [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 28 days after treatment stop ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures (submitted: October 27, 2014): Incidence of adverse events [ Time Frame: the 28 days treatment period ]
• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Gastroesophageal Reflux Disease
• Heartburn
• Sleep Disturbance

Intervention

• 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

Study Arms

• Experimental: Alginos plus Nexium
  sodium alginate 20ml (50mg/ml) once at bed time, and esomeprazole (40mg/tablet) 1 tablet once before breakfast, 4 weeks
  Interventions:

  • Drug: sodium alginate
  • Drug: esomeprazole
• Active Comparator: Nexium alone
  esomeprazole (40mg/tablet) 1 tablet once before breakfast, 4 weeks
  Intervention: Drug: esomeprazole

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: October 27, 2014): 340
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2016
• Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT02277886
• Other Study ID Numbers: ALG-NR-14
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Cheng-Tang Chiu, Chang Gung Memorial Hospital
• Study Sponsor: Chang Gung Memorial Hospital
• Collaborators: TTY Biopharm

Investigators

• Principal Investigator: Cheng-Tang Chiu, M.D.; Chang Gung Memorial Hospital

• PRS Account: Chang Gung Memorial Hospital
• Verification Date: November 2014