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

NCT01338077 | Completed Phase 3 DMC

• 2 other identifiers: TTYALG1001CGMH-IRB-99-1495A3
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroesophageal Reflux Disease; Heartburn

Keywords

Alginate; Gastroesophageal reflux disease

Outcome Measures

Primary Outcomes (1)

• Percentage of patients achieving adequate heartburn or regurgitation relief at day 28 as assessed by patient diary

  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

  4 weeks

Secondary Outcomes (4)

• Percentage of patients achieving adequate heartburn or regurgitation relief at day 14 as assessed by patient diar

  2 weeks

• Change from baseline of the Reflux Disease Questionnaire (RDQ) total score at days 14 & 28

  2 and 4 weeks

• Patients' overall satisfaction at the end of study

  4 weeks

• Number of antacid used during the treatment period

  4 weeks

Study Arms (2)

Sodium alginate

EXPERIMENTAL

Oral suspension, 50 mg/ml

Drug: Sodium alginate

Omeprazole

ACTIVE COMPARATOR

20 mg/cap

Drug: Omeprazole

Interventions

Sodium alginate DRUG

oral suspension, 50 mg/ml, 20 ml three times daily, 4 weeks

Also known as: Alginos

Sodium alginate

Omeprazole DRUG

20 mg capsule, 1 capsule once daily, 4 weeks

Also known as: Omelon

Omeprazole

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taipei, Taiwan, 105, Taiwan

Location

Related Publications (1)

• Chiu CT, Hsu CM, Wang CC, Chang JJ, Sung CM, Lin CJ, Chen LW, Su MY, Chen TH. Randomised clinical trial: sodium alginate oral suspension is non-inferior to omeprazole in the treatment of patients with non-erosive gastroesophageal disease. Aliment Pharmacol Ther. 2013 Nov;38(9):1054-64. doi: 10.1111/apt.12482. Epub 2013 Sep 11.

  PMID: 24024757 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn

Interventions

Alginates; Omeprazole

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polysaccharides; Carbohydrates; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Cheng-Tang Chiu, MD

  Chief, Department of Gastroenterology and Hepatology, Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Gastroenterology and Hepatology

Study Record Dates

• First Submitted: January 2, 2011
• First Posted: April 19, 2011
• Study Start: October 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 10, 2012

Record last verified: 2012-02

Locations

TW (1)