Trial Outcomes & Findings for Compound Sodium Alginate Double Action Chewable Tablets 4-hour Esophageal pH Study in GERD Patients (NCT NCT01872897)
NCT ID: NCT01872897
Last Updated: 2025-04-29
Results Overview
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
COMPLETED
PHASE3
45 participants
0 to 4 hours post-dose
2025-04-29
Participant Flow
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
|
Overall Study
STARTED
|
22
|
23
|
|
Overall Study
COMPLETED
|
21
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
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|---|---|---|
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Overall Study
Withdrawal by Subject
|
1
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0
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Baseline Characteristics
Compound Sodium Alginate Double Action Chewable Tablets 4-hour Esophageal pH Study in GERD Patients
Baseline characteristics by cohort
| Measure |
Group A
n=22 Participants
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.
|
Group B
n=23 Participants
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.
|
Total
n=45 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
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1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 15.27 • n=5 Participants
|
39.3 years
STANDARD_DEVIATION 16.90 • n=7 Participants
|
40.4 years
STANDARD_DEVIATION 15.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
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0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Afro-Caribbean
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
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22 participants
n=5 Participants
|
23 participants
n=7 Participants
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0 to 4 hours post-doseThe 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
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=44 Participants
Results from all subjects following dosing with Sodium Alginate Double Action Chewable Tablets
|
Placebo Tablets
n=44 Participants
Results from all subjects following dosing with placebo tablets
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|---|---|---|
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Percentage of Time During the 4-hour Post-dosing Period With pH Below pH 4
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5.14 percentage of time with pH below pH 4
Interval -0.27 to 10.56
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14.94 percentage of time with pH below pH 4
Interval 9.52 to 20.35
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SECONDARY outcome
Timeframe: 0 to 4 hours post-dosePercentage 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
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=44 Participants
Results from all subjects following dosing with Sodium Alginate Double Action Chewable Tablets
|
Placebo Tablets
n=44 Participants
Results from all subjects following dosing with placebo tablets
|
|---|---|---|
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Percentage of Time During the 4-hour Post-dosing Period With pH Below pH 5
|
10.40 percentage of time with pH below pH 5
Interval 3.4 to 17.4
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26.16 percentage of time with pH below pH 5
Interval 19.16 to 33.16
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SECONDARY outcome
Timeframe: 0 to 4 hours post-doseNumber 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
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=44 Participants
Results from all subjects following dosing with Sodium Alginate Double Action Chewable Tablets
|
Placebo Tablets
n=44 Participants
Results from all subjects following dosing with placebo tablets
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|---|---|---|
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Number of Occasions During the 4-hour Post-dosing Period When pH Falls Below pH 4
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11.5 Number of occasions pH fell below 4
Interval 3.4 to 19.6
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30.9 Number of occasions pH fell below 4
Interval 22.8 to 39.1
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SECONDARY outcome
Timeframe: 0 to 4 hours post-doseNumber 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
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=44 Participants
Results from all subjects following dosing with Sodium Alginate Double Action Chewable Tablets
|
Placebo Tablets
n=44 Participants
Results from all subjects following dosing with placebo tablets
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|---|---|---|
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Number of Occasions During the 4-hour Post-dosing Period When pH Falls Below pH 5
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17.3 Number of occasions pH fell below 5
Interval 9.5 to 25.1
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33.6 Number of occasions pH fell below 5
Interval 25.8 to 41.4
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SECONDARY outcome
Timeframe: 0 to 4 hours post-doseNumber 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
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=44 Participants
Results from all subjects following dosing with Sodium Alginate Double Action Chewable Tablets
|
Placebo Tablets
n=44 Participants
Results from all subjects following dosing with placebo tablets
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|---|---|---|
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Number of Reflux Episodes During the 4-hour Post-dosing Period With pH Below pH 4 for at Least 5 Minutes
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0.6 Number of reflux episodes
Interval -0.1 to 1.3
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1.4 Number of reflux episodes
Interval 0.7 to 2.1
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SECONDARY outcome
Timeframe: 0 to 1 hour post-dosePercentage 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
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=44 Participants
Results from all subjects following dosing with Sodium Alginate Double Action Chewable Tablets
|
Placebo Tablets
n=44 Participants
Results from all subjects following dosing with placebo tablets
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|---|---|---|
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Percentage of Time During the First Hour Post-dosing With pH Below pH 4
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2.00 percentage of time with pH below pH 4
Interval -3.43 to 7.44
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16.41 percentage of time with pH below pH 4
Interval 10.98 to 21.84
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SECONDARY outcome
Timeframe: 0 to 1 hour post-dosePercentage 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
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=44 Participants
Results from all subjects following dosing with Sodium Alginate Double Action Chewable Tablets
|
Placebo Tablets
n=44 Participants
Results from all subjects following dosing with placebo tablets
|
|---|---|---|
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Percentage of Time During the First Hour Post-dosing With pH Below pH 5
|
4.23 percentage of time with pH below pH 5
Interval -2.82 to 11.29
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27.60 percentage of time with pH below pH 5
Interval 20.55 to 34.65
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SECONDARY outcome
Timeframe: 0 to 1 hour post-doseNumber 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
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=44 Participants
Results from all subjects following dosing with Sodium Alginate Double Action Chewable Tablets
|
Placebo Tablets
n=44 Participants
Results from all subjects following dosing with placebo tablets
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|---|---|---|
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Number of Occasions During the First Hour Post-dosing When pH Falls Below pH 4
|
1.7 Number of occasions pH fell below 4
Interval -0.6 to 4.0
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9.1 Number of occasions pH fell below 4
Interval 6.7 to 11.4
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SECONDARY outcome
Timeframe: 0 to 1 hour post-doseNumber 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
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=44 Participants
Results from all subjects following dosing with Sodium Alginate Double Action Chewable Tablets
|
Placebo Tablets
n=44 Participants
Results from all subjects following dosing with placebo tablets
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|---|---|---|
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Number of Occasions During the First Hour Post-dosing When pH Falls Below pH 5
|
3.1 Number of occasions pH fell below 5
Interval 0.8 to 5.4
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9.5 Number of occasions pH fell below 5
Interval 7.2 to 11.8
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SECONDARY outcome
Timeframe: 0 to 4 hours post-doseThe 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
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=44 Participants
Results from all subjects following dosing with Sodium Alginate Double Action Chewable Tablets
|
Placebo Tablets
n=44 Participants
Results from all subjects following dosing with placebo tablets
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|---|---|---|
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The Longest Reflux Time During the 4-hour Post-dosing Period (i.e. the Longest Period With pH Below pH 4)
|
3.3 minutes
Interval -1.3 to 7.9
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9.6 minutes
Interval 5.1 to 14.2
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SECONDARY outcome
Timeframe: 0 to 4 hours post-doseThe 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.
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=44 Participants
Results from all subjects following dosing with Sodium Alginate Double Action Chewable Tablets
|
Placebo Tablets
n=44 Participants
Results from all subjects following dosing with placebo tablets
|
|---|---|---|
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The DeMeester Scores During the 4-hour Post-dosing Period
|
14.842 score on a scale
Interval 2.125 to 27.56
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38.987 score on a scale
Interval 26.27 to 51.704
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Adverse Events
Group A
Group B
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group A
n=22 participants at risk
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.
|
Group B
n=23 participants at risk
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.
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|---|---|---|
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Investigations
White blood cell count decreased
|
0.00%
0/22 • 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.
|
8.7%
2/23 • Number of events 2 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place