Compound Sodium Alginate Double Action Chewable Tablets 4-hour Esophageal pH Study in GERD Patients

Study Overview
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Brief Summary
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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).

Official Title
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A Multi-centred, Randomised, Open Label, Placebo-controlled, Two-period Crossover Study to Evaluate 4-hour Esophageal pH Change in GERD Patients After Administration of Compound Sodium Alginate Double Action Tablets or Placebo Tablets

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: Sodium Alginate Double Action Tablets
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: meets the diagnostic criteria for GERD with a GERD history of frequent episodes of GERD-related symptoms during the last 2 months prior to study screening. The patient must also meet the following criteria: The only or main symptom is heartburn (burning feeling back of breast bone) and/or acid reflux. Symptoms persists or have occurred repeatedly for more than 2 months; As assessed by the Investigator at screening by questioning of the patient, the frequency of occurrence of heartburn is ≥ 3 days/week and the score of severity of heartburn in general is ≥ moderate within 3 weeks before screening Exclusion Criteria: Patients who have a history of drug, solvent or alcohol abuse (weekly alcohol intake ≥ 140g). 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 [LA] classification grades C-D), Barrett's esophagus, 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 gastro-intestinal bleeding (hematochezia or hematemesis) within the last 3 months, and severe diseases of other major body systems. Patients who are observed at screening to have a hiatus hernia with a diameter which exceeds 3cm. Patients who have taken anti-cholinesterase drugs, traditional Chinese medicines for treating gastrointestinal disease, ulcerlmin or misoprostol preparations within 7 days prior to screening or throughout the study. Patients who have taken 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 (NSAIDs, 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 difficulty in swallowing. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium Alginate Double Action Tablets<br>Four Compound Sodium Alginate Double Action Chewable Tablets administered as a single dose | Drug: Sodium Alginate Double Action Tablets<br>* Four tablets as a single dose<br>* Other names: Gaviscon Double Action Tablets;|
| Placebo Comparator: Placebo tablets<br>Single dose of 4 Placebo tablets | Drug: Placebo<br>* 4 tablets as a single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 0 to 4 hours post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 0 to 4 hours post-dose | 
| Percentage of time during the first hour post dosing with pH below pH 4 | 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 | 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 | 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 | 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 | 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 | 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 | 0 to 4 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal Reflux Disease, GERD, Acid reflux, Compound Sodium Alginate Double Action Chewable Tablet, Gaviscon Double Action Tablets