Compound Sodium Alginate Oral Suspension Sachet Symptomatic Relief Study

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