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Gastro-esophageal Reflux Disease (GERD)Phase 3NCT02623062

Compound Sodium Alginate Oral Suspension Sachet Symptomatic Relief Study

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.

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

This study is being conducted in China to provide evidence for inclusion in applications to competent authorities that the Compound Sodium Alginate Oral Suspension sachet is effective in managing the symptoms of heartburn and acid regurgitation in patients with gastro-esophageal reflux disease (GERD). 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
644 participants
Where
1 siteChina
Study dates
Dec 2013to May 2016
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/NERD that comply with the Montreal definition of GERD/Nonerosive Esophageal Reflux Disease (NERD). GERD is a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications. The concept of NERD is preserved in the typical reflux syndrome without esophageal injury, while reflux esophagitis falls under the category of esophageal syndromes with esophageal injury.
  • GERD status: patients will be recruited by the Investigator from out-patient clinics, hospital database or those who respond to the advertising. Patients must have a GERD history of frequent episodes of GERD-related symptoms during the last 3 months, and must have had troublesome heartburn and/or regurgitation of at least moderate intensity on at least 4 days during the week before the start of screening.
  • Patients must be sufficiently literate to be able to complete the RDQ unaided.

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, peptic ulcer and/or ulcer complications, Zollinger-Ellison syndrome, gastric carcinoma, pyloric stenosis, oesophageal or gastric surgery, intestinal obstruction, current pernicious anaemia, indication for H-pylori eradication, hiatal hernias greater than 3 cm, known gastro-intestinal 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, Ulcermin or misoprostol preparations within 7 days prior to screening or throughout the study.
  • Patients who have taken Proton Pump Inhibitors (PPIs) during the 10 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 or PPI-based triple or quadruple therapy for eradication of H-pylori during the last 28 days prior to screening and throughout the study.
  • Patients who have taken any antacids within 24 hours before randomisation (Visit 2) and are unwilling or unable to withhold from taking them for the duration of the study.
  • Patients taking mucous membrane protection drugs or motility stimulants within the 5 days prior to screening and are unwilling or unable to withhold from taking them for the duration of the study.
  • Patients with difficulty in swallowing.
  • Patients with known hypophosphataemia, phenylketonuria or hypercalcaemia.
  • 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 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.
  • Patients with any clinically significant abnormal laboratory values.
  • Patients with severe/impaired renal function or insufficiency.
  • Any previous history of allergy or known intolerance to any of the formulation constituents.
  • Relevant clinically significant abnormalities in the physical examination, ECG and safety analysis.
  • Previously randomised into the study.
  • Employee at study site.
  • Partner or first-degree relative (e.g. parents, siblings or children) 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.
  • Patients taking or requiring to take macrolide antibiotics, such as erythromycin, azithromycin, from the day before screening
  • Patients who failed screening will not be allowed to re-enter the study

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-centred, Randomised, Double-blind, Two Arms, Parallel Group, Placebo-controlled Study to Assess the Effect of Compound Sodium Alginate Oral Suspension Sachet in Patients With Reflux Disease

This study is being conducted in China to provide evidence for inclusion in applications to competent authorities that the Compound Sodium Alginate Oral Suspension sachet is effective in managing the symptoms of heartburn and acid regurgitation in patients with gastro-esophageal reflux disease (GERD).

Read the detailed description

This is a multi-centre, randomised, double blind, two arm, parallel group, placebo-controlled clinical trial in patients with moderate to severe and frequent GERD symptoms. After signing a written informed consent, patients will undergo a screening period of up to 7 days. Patients who satisfy the study entry requirements within 7 days of consent, will be randomised to receive either Compound Sodium Alginate Oral Suspension sachets (20ml four times daily) or matching placebo sachets (20ml four times daily),for a 7- day treatment period. At the beginning and end of the treatment period, patients will be required to complete the Reflux Disease Questionnaire (RDQ).

In addition, at the end of the 7 (-1 day to +2 days) day treatment period, patients will be required to complete the Overall Treatment Evaluation.

Being tested
Compound Sodium Alginate Oral Suspension sachet, Matched placebo
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

    Contents of 2 sachets taken four times daily for 7 days

  • Matched placeboDrug

    Also called Placebo

    Contents of 2 sachets taken four times daily for 7 days

Study groups in NCT02623062
Study groupRoleWhat they receive
Compound Sodium Alginate Oral Suspension sachetsActive comparatorEach patient will be instructed to take Compound Sodium Alginate Oral Suspension sachet or matching placebo as a 2x10ml sachets four times daily regimen. Prior to dosing, all patients will be instructed by the Investigator on how they will take the medication. Patients will be instructed to start taking their medication the day after their randomisation visit (Day 1) for seven days (20ml taken four times a day: 30 minutes after breakfast, 30 minutes after lunch, 30 minutes after dinner and immediately before lying down for bed. Shake well before use).
Receives: Drug: Compound Sodium Alginate Oral Suspension sachet
Matching placebo sachetsPlacebo comparatorEach patient will be instructed to take Compound Sodium Alginate Oral Suspension sachet or matching placebo as a 2x10ml sachets four times daily regimen. Prior to dosing, all patients will be instructed by the Investigator on how they will take the medication. Patients will be instructed to start taking their medication the day after their randomisation visit (Day 1) for seven days (20ml taken four times a day: 30 minutes after breakfast, 30 minutes after lunch, 30 minutes after dinner and immediately before lying down for bed. Shake well before use).
Receives: Drug: Matched placebo

What is being measured

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

  1. Change in GERD dimension of RDQ

    Change from day 0 in the GERD dimension (heartburn and regurgitation combined) from the RDQ symptom scores after a 7-day treatment period

    Measured: 0 and 7 days

Secondary outcomes (4)

  1. Change in symptom score for each dimension of the RDQ separately

    Change from day 0 in symptom score for each dimension of the RDQ separately (heartburn and regurgitation)

    Measured: 0 and 7 days

  2. Change in frequency of each symptom separately (heartburn and regurgitation) from RDQ assessment

    Change from day 0 in frequency of each symptom separately (heartburn and regurgitation) from RDQ assessment.

    Measured: 0 and 7 days

  3. Change in intensity of each symptom separately (heartburn and regurgitation) from RDQ assessment

    Change from day 0 in intensity of each symptom separately (heartburn and regurgitation) from RDQ assessment

    Measured: 0 and 7 days

  4. Change in symptoms using the Overall Treatment Evaluation (OTE)

    Rating of change in symptoms using the Overall Treatment Evaluation (OTE)

    Measured: 0 and 7 days

Timeline

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

  1. First posted7 Dec 2015 (estimated)
  2. Study startDec 2013
  3. Primary completionMar 2016
  4. Study completionMay 2016

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
644 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02623062
Sponsor's protocol ID
GA1217
Status last verified
Jun 2016
First submitted
30 Nov 2015
Last updated
3 Jun 2016
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 3 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: finished, as of the sponsor's last update on 3 Jun 2016. 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 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?

Change in GERD dimension of RDQ (time frame: 0 and 7 days). 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 NCT02623062.

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 3 Jun 2016.

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