Phase
Condition
Gastroesophageal Reflux Disease (Gerd)
Esophageal Disorders
Colic
Treatment
Matching placebo tablets
Compound Sodium Alginate Double Action Chewable Tablets
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Current evidence of symptomatic GERD in accord with the Montreal definition.
Patients must have had troublesome heartburn and/or regurgitation (with or withoutdyspepsia symptoms) of at least mild or moderate intensity on at least 5 days duringthe week before the start of screening.
Exclusion
Exclusion Criteria:
Patients who have a history of drug, solvent or alcohol abuse.
Patients who have suffered cardiac chest pain within the last year.
Patients who have suffered a recent, significant unexplained weight loss of morethan 6 kg in the last 6 months.
Female patients of childbearing potential who, for the duration of the study, areeither unwilling or unable to take adequate contraceptive precautions or areunwilling to be sexually abstinent.
Pregnancy or lactating mother.
Patients with a history and/or symptom profile suggestive of the following: anyother gastrointestinal (GI) disease, erosive GERD (Los Angeles classification gradesC-D), Barrett's oesophagus, acute peptic ulcer and/or ulcer complications,Zollinger-Ellison syndrome, gastric carcinoma, pyloric stenosis, oesophageal orgastric surgery, intestinal obstruction, current pernicious anaemia, indication forH. pylori eradication therapy, known gastrointestinal bleeding (hematochezia orhematemesis) within 3 months prior to the study, and severe diseases of other majorbody systems.
Patients who were observed at screening to have a hiatus hernia with a diameterwhich exceeds 3 cm.
Patients who have taken anti-cholinesterase drugs, traditional Chinese medicines fortreating gastrointestinal disease, ulcermin or misoprostol preparations within 7days prior to screening or throughout the study.
Patients who have taken proton pump inhibitors (PPIs) during the 10 days prior toscreening, prokinetics or H2 antagonists during the 5 days prior to screening orsystemic glucocorticosteroids, non-steroidal anti-inflammatory drugs (except for lowdose aspirin which can be given for cardioprotection) on more than 3 consecutivedays or PPI-based triple or quadruple therapy for eradication of H-pylori during thelast 28 days.
Patients taking or requiring to take macrolide antibiotics, such as erythromycin,azithromycin, from the day before screening.
Patients with known hypophosphataemia, phenylketonuria or hypercalcaemia.
Patients with severe constipation, or history of intestinal obstruction.
In the opinion of the Investigator, patients with damaged heart or kidney functionand patients who require a low sodium diet.
Any previous history of allergy or known intolerance to any of the investigationalmedicinal products.
Study Design
Connect with a study center
RB Investigational Sites
Beijing,
ChinaSite Not Available
RB Investigational Sites
Shanghai,
ChinaSite Not Available
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