Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study
China1,107 participantsStarted 2013-06-05
Plain-language summary
This study is being conducted to provide evidence that Compound Sodium Alginate Double Action Chewable Tablets are effective in managing the symptoms of heartburn, acid regurgitation and dyspepsia in patients with Gastroesophageal Reflux Disease (GERD).
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
* …
What they're measuring
1
Change From Baseline in Reflux Disease Questionnaire (RDQ) Scores for the GERD Dimension