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

• Status: Terminated
• Trial end date: 2017-03-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• 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 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.

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, 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.

• 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.