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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,107
2 tablets four times daily
2 tablets four times daily
RB Investigational Sites
Beijing, China
RB Investigational Sites
Shanghai, China
Change From Baseline in Reflux Disease Questionnaire (RDQ) Scores for the GERD Dimension
The primary study endpoint is the change from baseline in RDQ symptom scores for the GERD dimension (heartburn and regurgitation) after a 7-day treatment period of Compound Sodium Alginate Double Action Chewable Tablets compared with a matched placebo. The RDQ is a 12-item self-administered questionnaire designed to assess the frequency and severity of heartburn, acid regurgitation and dyspepsia symptoms, with a minimum score of 0 and a maximum score of 60, with lower RDQ scores showing an improved outcome. The heartburn and acid regurgitation subscales can be combined into a GERD dimension, which has a minimum score of 0 and a maximum score of 40, with lower RDQ scores showing an improved outcome.
Time frame: 7 days
Change From Baseline in RDQ Scores for the Dyspepsia Dimension
The change from baseline in RDQ symptom scores for the dyspepsia dimension after a 7-day treatment period of Compound Sodium Alginate Double Action Chewable Tablets compared with a matched placebo. The dyspepsia subscale of the RDQ has a minimum score of 0 and a maximum score of 20, with lower RDQ scores showing an improved outcome.
Time frame: 7 days
Change From Baseline in RDQ Scores for the Heartburn Dimension
The change from baseline in RDQ symptom scores for the heartburn dimension after a 7-day treatment period of Compound Sodium Alginate Double Action Chewable Tablets compared with a matched placebo. The heartburn subscale of the RDQ has a minimum score of 0 and a maximum score of 20, with lower RDQ scores showing an improved outcome.
Time frame: 7 days
Change From Baseline in RDQ Scores for the Regurgitation Dimension
The change from baseline in RDQ symptom scores for the regurgitation dimension after a 7-day treatment period of Compound Sodium Alginate Double Action Chewable Tablets compared with a matched placebo. The regurgitation subscale of the RDQ has a minimum score of 0 and a maximum score of 20, with lower RDQ scores showing an improved outcome.
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Time frame: 7 days
Overall Treatment Evaluation (OTE) as a Measure of Patient Responsiveness/Satisfaction: Question 1 - Patient's Evaluation of the Change in Symptoms Over the Last 7 Days
Comparison between the 2 cohorts (Compound Sodium Alginate Double Action Chewable Tablets and matching placebo) in OTE as a measure for patient's responsiveness/satisfaction, determined at Visit 3, the end-of-study visit. Question 1 of the OTE assessed how the patients rated their responsiveness/satisfaction on a 15-point scale (from -7 = a very great deal worse to +7 = a very great deal better).
Time frame: 7 days
OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms
Comparison between the 2 cohorts (Compound Sodium Alginate Double Action Chewable Tablets and matching placebo) in OTE as a measure for patient's responsiveness/satisfaction, determined at Visit 3, the end-of-study visit. Question 2 of the OTE addressed how patients perceived the importance of the change of the clinical status on a 7-point scale (from 1 = not important to 7 = extremely important).
Time frame: 7 days
For Patients With Improvement Only: OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms
For patients with improvement only, comparison between the 2 cohorts (Compound Sodium Alginate Double Action Chewable Tablets and matching placebo) in OTE as a measure for patient's responsiveness/satisfaction, determined at Visit 3, the end-of-study visit. Question 2 of the OTE addressed how patients perceived the importance of the change of the clinical status on a 7-point scale (from 1 = not important to 7 = extremely important).
Time frame: 7 days