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Gastroesophageal Reflux DiseasePhase 3NCT01338077

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

A Phase 3 study testing Sodium alginate and Omeprazole in people with Gastroesophageal Reflux Disease and Heartburn, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Gastroesophageal Reflux Disease, Heartburn
What is being tested?
Sodium alginate and Omeprazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
195 participants
Where
1 siteTaiwan
Study dates
Oct 2010to Jan 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chang Gung Memorial Hospital

    Taipei, Taiwan, 105

Other trials in Taiwan

About this study

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)

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.

Read the 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.

Being tested
Sodium alginate, Omeprazole
Keywords
Alginate, Gastroesophageal reflux disease
Medical subject headings
Gastroesophageal Reflux, Heartburn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium alginateDrug

    Also called Alginos

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

  • OmeprazoleDrug

    Also called Omelon

    20 mg capsule, 1 capsule once daily, 4 weeks

Study groups in NCT01338077
Study groupRoleWhat they receive
Sodium alginateExperimentalOral suspension, 50 mg/ml
Receives: Drug: Sodium alginate
OmeprazoleActive comparator20 mg/cap
Receives: Drug: Omeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 weeks

Secondary outcomes (4)

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

    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

    Measured: 2 weeks

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

    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.

    Measured: 2 and 4 weeks

  3. Patients' overall satisfaction at the end of study

    The overall satisfaction is categorized as:0=very poor; 1=poor; 2=unsatisfactory; 3=satisfactory; 4=good; 5=very good

    Measured: 4 weeks

  4. Number of antacid used during the treatment period

    Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2011 (estimated)
  2. Study startOct 2010
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01338077
Sponsor's protocol ID
TTYALG1001
Other IDs
CGMH-IRB-99-1495A3
Status last verified
Feb 2012
First submitted
2 Jan 2011
Last updated
10 Feb 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24024757

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sodium alginate and Omeprazole in people with Gastroesophageal Reflux Disease and Heartburn, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients achieving adequate heartburn or regurgitation relief at day 28 as assessed by patient diary (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01338077, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2012.

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