Compound Sodium Alginate Oral Suspension Sachet Symptomatic Relief Study

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.

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