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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Alginate Double Action Chewable Tablets | Active Comparator | Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily |
|
| Matching placebo tablets | Placebo Comparator | Matching placebo tablets, 2 tablets four times daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Compound Sodium Alginate Double Action Chewable Tablets | Drug | 2 tablets four times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuan Yaozong, MD, PhD | Shanghai Jiao Tong University, School of Medicine, Shanghai, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RB Investigational Sites | Beijing | China | ||||
| RB Investigational Sites |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26228097 | Derived | Sun J, Yang C, Zhao H, Zheng P, Wilkinson J, Ng B, Yuan Y. Randomised clinical trial: the clinical efficacy and safety of an alginate-antacid (Gaviscon Double Action) versus placebo, for decreasing upper gastrointestinal symptoms in symptomatic gastroesophageal reflux disease (GERD) in China. Aliment Pharmacol Ther. 2015 Oct;42(7):845-54. doi: 10.1111/apt.13334. Epub 2015 Jul 31. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Alginate Double Action Chewable Tablets | Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily |
| FG001 | Matching Placebo Tablets | Matching placebo tablets, 2 tablets four times daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Eight subjects (3 in the Sodium Alginate Double Action Chewable Tablets group and 5 in the matching placebo tablets group) were randomized in the study, but not treated, and therefore not included in the safety population, from which baseline data were drawn.
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| ID | Title | Description |
|---|---|---|
| BG000 | Sodium Alginate Double Action Chewable Tablets | Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily |
| BG001 | Matching Placebo Tablets | Matching placebo tablets, 2 tablets four times daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data are from patients in the intent-to-treat population, which included all patients who were recruited into the study and had at least partially completed RDQ questionnaire for the trial therapy period or were known to have withdrawn from the study due to poor efficacy. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 7 days |
|
Up to 8 days, from after the first dose of IMP until no later than the day of the last dose of IMP +1
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sodium Alginate Double Action Chewable Tablets | Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastro-oesophageal reflux disease | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Data Controller | Reckitt Benckiser | clinicaldatacontroller@reckitt.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 28, 2013 | Dec 23, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2014 | Dec 23, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D004415 | Dyspepsia |
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Matching placebo tablets | Drug | 2 tablets four times daily |
|
|
| 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. | 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. | 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). | 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). | 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). | 7 days |
| Shanghai |
| China |
| Withdrawal by Subject |
|
| Lost to Follow-up |
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| No further need of investigational product |
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Sodium Alginate Double Action Chewable Tablets | Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily |
| OG001 | Matching Placebo Tablets | Matching placebo tablets, 2 tablets four times daily |
|
|
|
| Secondary | 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. | Data are from patients in the intent-to-treat population, which included all patients who were recruited into the study and had at least partially completed RDQ questionnaire for the trial therapy period or were known to have withdrawn from the study due to poor efficacy. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 7 days |
|
|
|
|
| Secondary | 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. | Data are from patients in the intent-to-treat population, which included all patients who were recruited into the study and had at least partially completed RDQ questionnaire for the trial therapy period or were known to have withdrawn from the study due to poor efficacy. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 7 days |
|
|
|
|
| Secondary | 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. | Data are from patients in the intent-to-treat population, which included all patients who were recruited into the study and had at least partially completed RDQ questionnaire for the trial therapy period or were known to have withdrawn from the study due to poor efficacy. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 7 days |
|
|
|
|
| Secondary | 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). | Data are from patients in the intent-to-treat population, which included all patients who were recruited into the study and had at least partially completed RDQ questionnaire for the trial therapy period or were known to have withdrawn from the study due to poor efficacy. | Posted | Count of Participants | Participants | 7 days |
|
|
|
|
| Secondary | 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). | Data are from patients in the intent-to-treat population, which included all patients who were recruited into the study and had at least partially completed RDQ questionnaire for the trial therapy period or were known to have withdrawn from the study due to poor efficacy. | Posted | Count of Participants | Participants | 7 days |
|
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|
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| Secondary | 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). | Data are from patients in the intent-to-treat population, which included all patients who were recruited into the study and had at least partially completed RDQ questionnaire for the trial therapy period or were known to have withdrawn from the study due to poor efficacy. | Posted | Count of Participants | Participants | 7 days |
|
|
|
|
| 0 |
| 549 |
| 1 |
| 549 |
| 0 |
| 549 |
| EG001 | Matching Placebo Tablets | Matching placebo tablets, 2 tablets four times daily | 0 | 550 | 0 | 550 | 0 | 550 |
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| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| -5 = A good deal worse |
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| -4 = Moderately worse |
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| -3 = Somewhat worse |
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| -2 = A little worse |
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| -1 = Almost the same, hardly any worse at all |
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| 0 = No change |
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| 1 = Almost the same, hardly any better at all |
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| 2 = A little better |
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| 3 = Somewhat better |
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| 4 = Moderately better |
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| 5 = A good deal better |
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| 6 = A great deal better |
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| 7 = A very great deal better |
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| Missing |
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| 3 = Somewhat important |
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| 4 = Moderately important |
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| 5 = Important |
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| 6 = Very important |
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| 7 = Extremely important |
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| Missing |
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| 3 = Somewhat important |
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| 4 = Moderately important |
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| 5 = Important |
|
| 6 = Very important |
|
| 7 = Extremely important |
|