Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study

Launched by RECKITT BENCKISER HEALTHCARE (UK) LIMITED · Jun 4, 2013

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Current evidence of symptomatic GERD in accord with the Montreal definition.
• • Patients must have had troublesome heartburn and/or regurgitation (with or without dyspepsia symptoms) of at least mild or moderate intensity on at least 5 days during the week before the start of screening.
• 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 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, erosive GERD (Los Angeles classification grades C-D), Barrett's oesophagus, acute 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 therapy, known gastrointestinal bleeding (hematochezia or hematemesis) within 3 months prior to the study, and severe diseases of other major body systems.
• • Patients who were observed at screening to have a hiatus hernia with a diameter which exceeds 3 cm.
• • 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 (except for low dose aspirin which can be given for cardioprotection) on more than 3 consecutive days or PPI-based triple or quadruple therapy for eradication of H-pylori during the last 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 function and patients who require a low sodium diet.
• • Any previous history of allergy or known intolerance to any of the investigational medicinal products.