Efficacy and Safety of Sodium Alginate Oral Suspension to Treat Non-erosive Gastro-esophageal Reflux Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cheng-Tang Chiu, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01338077
First received: January 2, 2011
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

About 60% of patients with typical gastroesophageal reflux symptoms such as heartburn and regurgitation are considered to have non-erosive reflux disease (NERD). Patients with NERD show an overall poorer response to PPI treatment than patients with erosive reflux disease. Sodium alginate oral suspension is a medication indicated for the relief of gastroesophageal reflux symptoms. This multi-center, double blind, randomized trial aims to compare the efficacy and safety profiles of sodium alginate oral suspension (50 mg/ml) 20 ml three times daily with that of omeprazole (20 mg/capsule) 1 capsule once daily for the treatment of NERD patients in Taiwan. Efficacy assessments include percentage of patients achieving adequate relief of heartburn or regurgitation after 4 weeks treatment, improvement of reflux symptoms as assessed by reflux disease questionnaire before and after treatment, and patients overall satisfaction at the end of study. Safety assessments include incidence of adverse events and change of the laboratory test results. The study hypothesis is that treatment with sodium alginate is non-inferior to omeprazole in relieving heartburn or regurgitation symptoms of the NERD patients.


Condition Intervention Phase
Gastroesophageal Reflux Disease
Heartburn
Drug: Sodium alginate
Drug: Omeprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Double-blind, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Sodium Alginate Oral Suspension (50 mg/ml) in Comparison to Omeprazole (20 mg/Cap) to Treat Non-erosive Gastro-esophageal Reflux Disease (NERD)

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Percentage of patients achieving adequate heartburn or regurgitation relief at day 28 as assessed by patient diary [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Adequate heartburn or regurgitation relief is defined as no more than 1 day of mild heartburn or regurgitation episodes in the last 7 days before day 28


Secondary Outcome Measures:
  • Percentage of patients achieving adequate heartburn or regurgitation relief at day 14 as assessed by patient diar [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Adequate heartburn or regurgitation relief is defined as no more than 1 day of mild heartburn or regurgitation episodes in the last 7 days before day 14

  • Change from baseline of the Reflux Disease Questionnaire (RDQ) total score at days 14 & 28 [ Time Frame: 2 and 4 weeks ] [ Designated as safety issue: No ]
    RDQ is a 12-item self-administered questionnaire and there are 3 subscales that evaluate frequency and severity of heartburn, regurgitation and dyspepsia. Each item is scored on a 6-point Likert scale ranging from 0 to 5. The RDQ total scores are determined by the sum of 12-item scores.

  • Patients' overall satisfaction at the end of study [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The overall satisfaction is categorized as:0=very poor; 1=poor; 2=unsatisfactory; 3=satisfactory; 4=good; 5=very good

  • Number of antacid used during the treatment period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 195
Study Start Date: October 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sodium alginate
Oral suspension, 50 mg/ml
Drug: Sodium alginate
oral suspension, 50 mg/ml, 20 ml three times daily, 4 weeks
Other Name: Alginos
Active Comparator: Omeprazole
20 mg/cap
Drug: Omeprazole
20 mg capsule, 1 capsule once daily, 4 weeks
Other Name: Omelon

Detailed Description:

This multi-center, double blind, randomized trial aims to compared the efficacy and safety profiles of sodium alginate oral suspension (50 mg/ml) 20 ml three times daily with that of omeprazole (20 mg/capsule) 1 capsule once daily for the treatment of non-erosive reflux disease (NERD) patients in Taiwan. Patients will be included into study if they are diagnosed as NERD; with heartburn or regurgitation (either one) as main symptom at least 2 days a week and had been present for ≧1 month before screening; with heartburn or regurgitation (either one) during the 7 days screening period, either with frequency for ≧4 days of mild symptom, or ≧ 2 days of moderate to severe symptom; and have signed the informed consent. Patients will be excluded if they are diagnosed as erosive gastroesophageal reflux disease (GERD), Barrett's esophagus or esophageal stricture; with active or healing gastroduodenal ulcer (except scars); with history of gastric, duodenal or esophageal surgery; with intrahepatic stone, gallstone, gallbladder sludge, hepatic or pancreatic carcinoma as evidenced by abdominal ultrasonography, with ischemic heart disease as evidenced by electrocardiogram; taking a proton pump inhibitor (PPI) within 14 days before screening, or a H2-blocker, prokinetic agent or antacid within 7 days before screening; or with clinically significant liver or kidney disease. The primary efficacy endpoint is percentage of patients achieving adequate heartburn (defined as a burning feeling or pain behind the breast bone) or regurgitation (defined as an acid taste in the mouth or unpleasant movement of material upwards from the stomach) relief at day 28 as assessed by patient diary. The secondary efficacy endpoints are percentage of patients achieving adequate heartburn or regurgitation relief at day 14; change from baseline of the reflux disease questionnaire total score at day 14 & 28; patients' overall satisfaction at the end of study; and number of antacid used during the 4-week treatment period. The safety endpoints are incidence of adverse events, and changes in laboratory test results (hematology, biochemistry, and urinalysis). The study hypothesis is that treatment with sodium alginate is non-inferior to omeprazole in relieving heartburn or regurgitation symptoms of the NERD patients.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with age of 20-75 years old (inclusive) in Taiwan of both genders
  • Out-patients who had been diagnosed as non-erosive gastroesophageal reflux disease (NERD)
  • Patients with heartburn or regurgitation (either one) as main symptom at least 2 days a week and had been present for > or = 1 month before screening
  • Patients with heartburn or regurgitation (either one) during the 7 days screening period, either with frequency for > or = 4 days of mild symptom, or for > or = 2 days of moderate to severe symptom
  • Patients have signed the informed consent form

Exclusion Criteria:

  • Patients with erosive gastroesophageal reflux disease (GERD), Barrett's esophagus or esophageal stricture
  • Patients with active or healing gastroduodenal ulcer (except scars)
  • Patients with history of gastric, duodenal or esophageal surgery
  • Patients with malignant disease of any kind
  • Patients with intrahepatic stone, gallstone, gallbladder sludge, hepatic or pancreatic carcinoma as evidenced by abdominal ultrasonography
  • Patients with ischemic heart disease as evidenced by electrocardiogram
  • Female patients who are pregnant or nursing mother
  • Patients with a history of allergy to any of the study drugs or their related compounds
  • Patients with a history of alcohol or drug abuse
  • Patients with clinically significant liver disease (aspartate aminotransferase (AST), alanine aminotransferase (ALT)>2 upper limits of normal)
  • Patients with clinically significant renal disease (serum creatinine >1.5 mg/dl)
  • Patients taken a proton pump inhibitor (PPI) within 14 days before screening, or a H2-blocker, prokinetic agent or antacid within 7 days before screening
  • Patients participated any investigational drug trial within 4 weeks before screening
  • Patients with any other conditions or diseases that investigator considers it is not appropriate to enter the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01338077

Locations
Taiwan
Chang Gung Memorial Hospital
Taipei, Taiwan, 105
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Cheng-Tang Chiu, MD Chief, Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital
  More Information

No publications provided by Chang Gung Memorial Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cheng-Tang Chiu, Chief, Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01338077     History of Changes
Other Study ID Numbers: TTYALG1001, CGMH-IRB-99-1495A3
Study First Received: January 2, 2011
Last Updated: February 9, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Alginate
Gastroesophageal reflux disease

Additional relevant MeSH terms:
Gastroesophageal Reflux
Heartburn
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Alginic acid
Omeprazole
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014