Overview

Compound Sodium Alginate Oral Suspension Sachet Symptomatic Relief Study

Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Reckitt Benckiser Healthcare (UK) Limited
Treatments:
Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
Alginic acid
Criteria
Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- 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