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Gastro-esophageal Reflux Disease (GERD)Phase 3NCT02619747

Compound Sodium Alginate Oral Suspension Sachet 4-hour Esophageal pH Study in GERD Patients

A Phase 3 study testing Compound Sodium Alginate Oral Suspension sachet in people with Gastro-esophageal Reflux Disease (GERD), run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Multi-centre, randomised, open-label, placebo-controlled, two-period crossover study of 4 hour pH monitoring following a refluxogenic meal and drink. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Gastro-esophageal Reflux Disease (GERD)
What is being tested?
Compound Sodium Alginate Oral Suspension sachet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteChina
Study dates
Apr 2014to 31 Mar 2017
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary diagnosis: Current evidence of symptomatic GERD in accord with the Montreal definition. Patients should have a GERD history of frequent episodes of GERD-related symptoms during at least the last 2 months prior to study screening. The patient must also meet the following criteria:
  • The main symptom is heartburn and/or acid reflux. Symptoms persist or have occurred repeatedly for at least the last 2 months;
  • The frequency of occurrence of heartburn is ≥ 3 days/week and the score of severity of heartburn in general is moderate or severe within 3 weeks before screening
  • Patients who are willing to consume the entire standard refluxogenic test meal.
  • Patients who have a screening 24 h pH monitoring test assessing the percentage of time when the pH falls below pH 4 which confirms significant acid reflux of >4.2% over the 24 h period.

Who cannot join

  • Patients who have a history of drug, solvent or alcohol abuse (weekly alcohol intake ≥ 140g).
  • Patients who have suffered cardiac chest pain within the last year.
  • Patients who have suffered a recent, significant unexplained weight loss of more than 6 kg in the last 6 months.
  • Female patients of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent.
  • Pregnancy or lactating mother.
  • Patients with a history and/or symptom profile suggestive of the following: any other gastrointestinal (GI) disease (e.g. gastric or duodenal erosions and polyps larger than 0.5 cm), erosive GERD Los Angeles [LA] classification grades C-D, Barrett's esophagus, acute peptic ulcer and/or ulcer complications, Zollinger-Ellison syndrome, gastric carcinoma, pyloric stenosis, oesophageal or gastric surgery, intestinal obstruction, current pernicious anaemia, hiatal hernias greater than 3 cm, requirement for low sodium diet, known gastrointestinal bleeding (hematochezia or hematemesis) within the last 3 months, and severe diseases of other major body systems.
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  • Patients who have taken anti-cholinesterase drugs, traditional Chinese medicines for treating gastrointestinal disease, sucralfate or misoprostol preparations within 7 days prior to screening or throughout the study.
  • Patients who have taken Proton Pump Inhibitors (PPIs) during the 28 days prior to screening, prokinetics or H2 antagonists during the 5 days prior to screening, or systemic glucocorticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs except low dose aspirin given for cardioprotection) on more than 3 consecutive days during the last 28 days prior to screening.
  • Patients who have taken any antacids within 24 hours before screening (Visit 1) and throughout the remainder of the study.
  • Patients taking mucous membrane protection drugs or motility stimulants for 5 days prior to screening and throughout the study.
  • Patients who are vegetarian.
  • Patients with difficulty in swallowing.
  • Patients with known hypophosphataemia, phenylketonuria or hypercalcaemia.
  • Patients who have previously undergone esophageal, gastric or duodenal surgery at any time or who have undergone any other major surgery with general anaesthesia within the last three months.
  • Patients with severe constipation, or history of intestinal obstruction.
  • In the opinion of the Investigator, patients with insufficient heart or kidney function and patients who require a low sodium diet.
  • Patients either with any co-existing condition which, in the opinion of the Investigator, would be likely to compromise patient safety or interfere with assessment of efficacy; or with any clinically significant abnormal laboratory values.
  • Patients with impaired renal function or severe renal insufficiency.
  • Any previous history of allergy or known intolerance to any of the formulation constituents
  • Clinically significant abnormalities in the physical examination, electrocardiogram (ECG) and safety analysis.
  • Patients taking or requiring to take macrolide antibiotics, such as erythromycin, azithromycin, from the day before screening.
  • Previously randomised into the study.
  • Employee at study site.
  • Partner or first-degree relative of the Investigator.
  • Participation in a clinical study in the previous 6 months.
  • Unable in the opinion of the Investigator to comply fully with the study requirements.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affilated Hospital Sun Yat-Sen University

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: A Multi-centre, Randomised, Open Label, Placebo-controlled, Two-period Crossover Study to Evaluate 4-hour Esophageal pH Change in GERD Patients After Administration of Compound Sodium Alginate Oral Suspension Sachets or Placebo Sachets

Multi-centre, randomised, open-label, placebo-controlled, two-period crossover study of 4 hour pH monitoring following a refluxogenic meal and drink.

Read the detailed description

This is a multi-centre, randomised, open-label, placebo-controlled, two-period crossover study. After signing a written informed consent (ICF), patients will undergo a screening period of up to 10 days (Visit 1) which will require the patient to return to the clinic on several occasions. At the start of the screening process patients will have 24 hour (h) pH monitoring which will include one standardised refluxogenic meal after a 4 h fast. The 24 h pH monitoring results will be used as a key criteria for patient eligibility and to provide the patients with diagnostic information on their symptoms. After 24 h pH monitoring, eligible patients will be supplied with Compound Sodium Alginate Oral Suspension sachet to take as required for symptom relief between visits (up to 2×10ml sachets four times daily: 30 minutes after breakfast, 30 minutes after lunch, 30 minutes after dinner and immediately before lying down for bed, stopping dosing at least 24 hours prior to Visit 2).

Patients who satisfy the study entry requirements within 10 days of consent, will be randomised to receive either two Compound Sodium Alginate Oral Suspension sachets (2×10ml) or two placebo sachets (2×10ml) following placement of a pH electrode after a 4 h fast and a standardised refluxogenic meal at Visit 2.

Upon completion of the Visit 2 4-hour post-dose pH monitoring period patients will be re-supplied with Compound Sodium Alginate Oral Suspension sachets to take as required for symptom relief (up to 2×10ml sachets four times daily: 30 minutes after breakfast, 30 minutes after lunch, 30 minutes after dinner and immediately before lying down for bed, stopping dosing at least 24 hours prior to Visit 3) for 7 ± 2 days. Patients will return for Visit 3 after 7 ± 2 days. Visit 3 will consist of repeat pH catheter insertion (4 hour fast followed by refluxogenic test meal consumption) and pH monitoring, receiving the alternative randomised treatment at Visit 3.

Being tested
Compound Sodium Alginate Oral Suspension sachet, Matched placebo
Keywords
pH monitoring
Medical subject headings
Gastroesophageal Reflux

What participants receive

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

  • Compound Sodium Alginate Oral Suspension sachetDrug

    Also called Gaviscon sachets

  • Matched placeboDrug

Study groups in NCT02619747
Study groupRoleWhat they receive
Compound Sodium Alginate Oral Suspension sachetActive comparatorSingle dose of contents of two 10 ml sachets of Compound Sodium Alginate Oral Suspension
Receives: Drug: Compound Sodium Alginate Oral Suspension sachet; Drug: Matched placebo
Matched placeboPlacebo comparatorSingle dose of contents of two 10 ml sachets of matched placebo
Receives: Drug: Compound Sodium Alginate Oral Suspension sachet; Drug: Matched placebo

What is being measured

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

  1. Percentage of time during the 4 hour post dosing period with pH below pH 4.

    Measured: 4 hours post-dose

Secondary outcomes (11)

  1. Percentage of time during the 4 hour post dosing period with pH below pH 5

    Measured: 4 hours post-dose

  2. Number of occasions during the 4 hour post dosing period when pH falls below pH 4

    Measured: 4 hours post-dose

  3. Number of occasions during the 4 hour post dosing period when pH falls below pH 5

    Measured: 4 hours post-dose

  4. Number of reflux episodes during the 4 hour post dosing period with pH below pH 4 for at least 5 minutes

    Measured: 4 hours post-dose

  5. Percentage of time during the first hour post dosing with pH below pH 4

    Measured: 1 hour post-dose

  6. Percentage of time during the first hour post dosing with pH below pH 5

    Measured: 1 hour post-dose

  7. Number of occasions during the first hour post dosing when pH falls below pH 4

    Measured: 1 hour post-dose

  8. Number of occasions during the first hour post dosing when pH falls below pH 5

    Measured: 1 hour post-dose

  9. The longest reflux time during the 4 hour post dosing period

    Measured: 4 hours post-dose

  10. DeMeester score

    Measured: 4 hours post-dose

  11. Overall proportion of patients with adverse events (AEs)

    Measured: 20 days

Timeline

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

  1. First posted2 Dec 2015 (estimated)
  2. Study startApr 2014
  3. Primary completion31 Mar 2017
  4. Study completion31 Mar 2017

Why it stopped: Problems with recruitment

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02619747
Sponsor's protocol ID
GA1218
Status last verified
Oct 2017
First submitted
30 Nov 2015
Last updated
6 Oct 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Compound Sodium Alginate Oral Suspension sachet in people with Gastro-esophageal Reflux Disease (GERD), run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in China.

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 26 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: stopped early, as of the sponsor's last update on 6 Oct 2017. 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 China. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Problems with recruitment). Results are not available in the source record.

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 time during the 4 hour post dosing period with pH below pH 4. (time frame: 4 hours post-dose). 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 NCT02619747.

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 6 Oct 2017.

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