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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium Alginate Double Action Chewable Tablets, then Placebo tablets | Active Comparator | 4 Compound Sodium Alginate Double Action Chewable Tablets administered as a single dose, followed by 7 days of Compound Sodium Alginate Double Action Chewable Tablets (two tablets four times daily), then a single dose of 4 Placebo tablets |
|
| Placebo tablets, then Sodium Alginate Double Action Chewable Tablets | Placebo Comparator | Single dose of 4 Placebo tablets, followed by 7 days of Compound Sodium Alginate Double Action Chewable Tablets (two tablets four times daily), then a single dose of 4 Compound Sodium Alginate Double Action Chewable Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Alginate Double Action Chewable Tablets | Drug | 4 tablets as a single dose |
|
| 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 tablets | 0 to 4 hours post-dose |
| 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 |
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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:
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 | Shanghai | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Participants in Group A received a single dose (four tablets) of Sodium Alginate Double Action Chewable Tablets at Visit 2, followed by 7 days of Compound Sodium Alginate Double Action Chewable Tablets (two tablets four times daily) and a single dose (four tablets) of Placebo tablets at Visit 3. |
| FG001 | Group B | Participants in Group B received a single dose (four tablets) of placebo tablets at Visit 2, followed by 7 days of Compound Sodium Alginate Double Action Chewable Tablets (two tablets four times daily) and a single dose (four tablets) of Sodium Alginate Double Action Chewable Tablets at Visit 3. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Participants in Group A received a single dose (four tablets) of Sodium Alginate Double Action Chewable Tablets at Visit 2, followed by 7 days of Compound Sodium Alginate Double Action Chewable Tablets (two tablets four times daily) and a single dose (four tablets) of Placebo tablets at Visit 3. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 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 | Posted | Least Squares Mean | 95% Confidence Interval | percentage of time with pH below pH 4 | 0 to 4 hours post-dose |
|
Up to 19 days, from the time informed consent was provided until the Day 7 (+/- 2 days) visit
In both reported AEs, blood samples, from which the TEAEs of "White blood cell count decreased" were identified, were taken 1 week after administration of 4 placebo tablets followed by 7 days of Sodium Alginate Double Action Chewable Tablets (2 tablets 4times daily), and ~4 hours after administration of 4 Sodium Alginate Double Action Chewable Tablets. It was not possible to definitely attribute these AEs to one or other of the interventions, so AEs are reported by group, not by intervention.
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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 | Group A | Participants in Group A received a single dose (four tablets) of Sodium Alginate Double Action Chewable Tablets at Visit 2, followed by 7 days of Compound Sodium Alginate Double Action Chewable Tablets (two tablets four times daily) and a single dose (four tablets) of Placebo tablets at Visit 3. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| White blood cell count decreased | Investigations | MedDRA (16.0) | 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 | Jun 4, 2013 | Dec 23, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 17, 2014 | Dec 23, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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|
| Placebo | Drug | 4 tablets as a single dose |
|
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 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 | 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. 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. | 0 to 4 hours post-dose |
| Group B |
Participants in Group B received a single dose (four tablets) of placebo tablets at Visit 2, followed by 7 days of Compound Sodium Alginate Double Action Chewable Tablets (two tablets four times daily) and a single dose (four tablets) of Sodium Alginate Double Action Chewable Tablets at Visit 3. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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 | Posted | Least Squares Mean | 95% Confidence Interval | percentage of time with pH below pH 5 | 0 to 4 hours post-dose |
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| Secondary | 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 | Posted | Least Squares Mean | 95% Confidence Interval | Number of occasions pH fell below 4 | 0 to 4 hours post-dose |
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| Secondary | 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 | Posted | Least Squares Mean | 95% Confidence Interval | Number of occasions pH fell below 5 | 0 to 4 hours post-dose |
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| Secondary | 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 | Posted | Least Squares Mean | 95% Confidence Interval | Number of reflux episodes | 0 to 4 hours post-dose |
|
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|
|
| Secondary | 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 | Posted | Least Squares Mean | 95% Confidence Interval | percentage of time with pH below pH 4 | 0 to 1 hour post-dose |
|
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|
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| Secondary | 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 | Posted | Least Squares Mean | 95% Confidence Interval | percentage of time with pH below pH 5 | 0 to 1 hour post-dose |
|
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| Secondary | 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 | Posted | Least Squares Mean | 95% Confidence Interval | Number of occasions pH fell below 4 | 0 to 1 hour post-dose |
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| Secondary | 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 | Posted | Least Squares Mean | 95% Confidence Interval | Number of occasions pH fell below 5 | 0 to 1 hour post-dose |
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| Secondary | 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 | Posted | Least Squares Mean | 95% Confidence Interval | minutes | 0 to 4 hours post-dose |
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| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 0 to 4 hours post-dose |
|
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|
| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | Group B | Participants in Group B received a single dose (four tablets) of placebo tablets at Visit 2, followed by 7 days of Compound Sodium Alginate Double Action Chewable Tablets (two tablets four times daily) and a single dose (four tablets) of Sodium Alginate Double Action Chewable Tablets at Visit 3. | 0 | 23 | 0 | 23 | 2 | 23 |
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| D004066 | Digestive System Diseases |