This study is being conducted in China to provide evidence for inclusion in applications to competent authorities that the Compound Sodium Alginate Oral Suspension sachet is effective in managing the symptoms of heartburn and acid regurgitation in patients with gastro-esophageal reflux disease (GERD).
This is a multi-centre, randomised, double blind, two arm, parallel group, placebo-controlled clinical trial in patients with moderate to severe and frequent GERD symptoms. After signing a written informed consent, patients will undergo a screening period of up to 7 days. Patients who satisfy the study entry requirements within 7 days of consent, will be randomised to receive either Compound Sodium Alginate Oral Suspension sachets (20ml four times daily) or matching placebo sachets (20ml four times daily),for a 7- day treatment period. At the beginning and end of the treatment period, patients will be required to complete the Reflux Disease Questionnaire (RDQ). In addition, at the end of the 7 (-1 day to +2 days) day treatment period, patients will be required to complete the Overall Treatment Evaluation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
644
Contents of 2 sachets taken four times daily for 7 days
Contents of 2 sachets taken four times daily for 7 days
The First Affilated Hospital Sun Yat-Sen University
Guangzhou, Guangdong, China
Change in GERD dimension of RDQ
Change from day 0 in the GERD dimension (heartburn and regurgitation combined) from the RDQ symptom scores after a 7-day treatment period
Time frame: 0 and 7 days
Change in symptom score for each dimension of the RDQ separately
Change from day 0 in symptom score for each dimension of the RDQ separately (heartburn and regurgitation)
Time frame: 0 and 7 days
Change in frequency of each symptom separately (heartburn and regurgitation) from RDQ assessment
Change from day 0 in frequency of each symptom separately (heartburn and regurgitation) from RDQ assessment.
Time frame: 0 and 7 days
Change in intensity of each symptom separately (heartburn and regurgitation) from RDQ assessment
Change from day 0 in intensity of each symptom separately (heartburn and regurgitation) from RDQ assessment
Time frame: 0 and 7 days
Change in symptoms using the Overall Treatment Evaluation (OTE)
Rating of change in symptoms using the Overall Treatment Evaluation (OTE)
Time frame: 0 and 7 days
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