This study is being conducted to assess the effectiveness of the Compound Sodium Alginate Double Action Chewable Tablets compared to placebo on acidic reflux events into the esophagus in patients diagnosed with Gastroesophageal Reflux Disease (GERD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
45
4 tablets as a single dose
4 tablets as a single dose
RB Investigational Sites
Shanghai, China
Percentage of Time During the 4-hour Post-dosing Period With pH Below pH 4
The primary efficacy endpoint will be the percentage of time during the 4-hour post-dosing period with pH below pH 4 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Time frame: 0 to 4 hours post-dose
Percentage of Time During the 4-hour Post-dosing Period With pH Below pH 5
Percentage of time during the 4-hour post-dosing period with pH below pH 5 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Time frame: 0 to 4 hours post-dose
Number of Occasions During the 4-hour Post-dosing Period When pH Falls Below pH 4
Number of occasions during the 4-hour post-dosing period when pH falls below pH 4 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Time frame: 0 to 4 hours post-dose
Number of Occasions During the 4-hour Post-dosing Period When pH Falls Below pH 5
Number of occasions during the 4-hour post-dosing period when pH falls below pH 5 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Time frame: 0 to 4 hours post-dose
Number of Reflux Episodes During the 4-hour Post-dosing Period With pH Below pH 4 for at Least 5 Minutes
Number of reflux episodes during the 4-hour post-dosing period with pH below pH 4 for at least 5 minutes for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Time frame: 0 to 4 hours post-dose
Percentage of Time During the First Hour Post-dosing With pH Below pH 4
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Percentage of time during the first hour post-dosing with pH below pH 4 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Time frame: 0 to 1 hour post-dose
Percentage of Time During the First Hour Post-dosing With pH Below pH 5
Percentage of time during the first hour post-dosing with pH below pH 5 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Time frame: 0 to 1 hour post-dose
Number of Occasions During the First Hour Post-dosing When pH Falls Below pH 4
Number of occasions during the first hour post-dosing when pH falls below pH 4 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Time frame: 0 to 1 hour post-dose
Number of Occasions During the First Hour Post-dosing When pH Falls Below pH 5
Number of occasions during the first hour post-dosing when pH falls below pH 5 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Time frame: 0 to 1 hour post-dose
The Longest Reflux Time During the 4-hour Post-dosing Period (i.e. the Longest Period With pH Below pH 4)
The longest reflux time during the 4-hour post-dosing period (i.e. the longest period with pH below pH 4) for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Time frame: 0 to 4 hours post-dose
The DeMeester Scores During the 4-hour Post-dosing Period
The DeMeester scores during the 4-hour post-dosing period for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets. The DeMeester score is a composite score of the acid exposure during a prolonged ambulatory pH monitoring. The parameters that constitute the score are number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position, respectively. The DeMeester score is the sum of the scores calculated for each of the 6 parameters. A score more than 14.7 is considered abnormal acid reflux, scores between 14.7 and 100 are regarded as mild-to-moderate GERD, and a score greater than 100 is regarded as severe GERD.
Time frame: 0 to 4 hours post-dose