Trial Outcomes & Findings for Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study (NCT NCT01869491)
NCT ID: NCT01869491
Last Updated: 2025-05-08
Results Overview
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.
COMPLETED
PHASE3
1107 participants
7 days
2025-05-08
Participant Flow
Participant milestones
| Measure |
Sodium Alginate Double Action Chewable Tablets
Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily
|
Matching Placebo Tablets
Matching placebo tablets, 2 tablets four times daily
|
|---|---|---|
|
Overall Study
STARTED
|
552
|
555
|
|
Overall Study
COMPLETED
|
531
|
531
|
|
Overall Study
NOT COMPLETED
|
21
|
24
|
Reasons for withdrawal
| Measure |
Sodium Alginate Double Action Chewable Tablets
Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily
|
Matching Placebo Tablets
Matching placebo tablets, 2 tablets four times daily
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
5
|
|
Overall Study
Lack of Efficacy
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
7
|
|
Overall Study
Lost to Follow-up
|
11
|
9
|
|
Overall Study
No further need of investigational product
|
1
|
0
|
Baseline Characteristics
Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study
Baseline characteristics by cohort
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=549 Participants
Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily
|
Matching Placebo Tablets
n=550 Participants
Matching placebo tablets, 2 tablets four times daily
|
Total
n=1099 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
549 participants
n=5 Participants
|
550 participants
n=7 Participants
|
1099 participants
n=5 Participants
|
|
Age, Continuous
|
45.0 Years
STANDARD_DEVIATION 11.81 • n=5 Participants
|
44.8 Years
STANDARD_DEVIATION 11.84 • n=7 Participants
|
44.9 Years
STANDARD_DEVIATION 11.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
280 Participants
n=5 Participants
|
262 Participants
n=7 Participants
|
542 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
269 Participants
n=5 Participants
|
288 Participants
n=7 Participants
|
557 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
548 Participants
n=5 Participants
|
550 Participants
n=7 Participants
|
1098 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Afro-Caribbean
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: 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.
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.
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=536 Participants
Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily
|
Matching Placebo Tablets
n=537 Participants
Matching placebo tablets, 2 tablets four times daily
|
|---|---|---|
|
Change From Baseline in Reflux Disease Questionnaire (RDQ) Scores for the GERD Dimension
|
-1.27 score on a scale
Interval -1.37 to -1.16
|
-1.06 score on a scale
Interval -1.17 to -0.95
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 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.
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.
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=536 Participants
Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily
|
Matching Placebo Tablets
n=537 Participants
Matching placebo tablets, 2 tablets four times daily
|
|---|---|---|
|
Change From Baseline in RDQ Scores for the Dyspepsia Dimension
|
-0.98 score on a scale
Interval -1.1 to -0.86
|
-0.80 score on a scale
Interval -0.91 to -0.68
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 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.
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.
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=536 Participants
Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily
|
Matching Placebo Tablets
n=537 Participants
Matching placebo tablets, 2 tablets four times daily
|
|---|---|---|
|
Change From Baseline in RDQ Scores for the Heartburn Dimension
|
-1.16 score on a scale
Interval -1.28 to -1.04
|
-0.95 score on a scale
Interval -1.07 to -0.83
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 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.
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.
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=536 Participants
Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily
|
Matching Placebo Tablets
n=537 Participants
Matching placebo tablets, 2 tablets four times daily
|
|---|---|---|
|
Change From Baseline in RDQ Scores for the Regurgitation Dimension
|
-1.37 score on a scale
Interval -1.48 to -1.26
|
-1.16 score on a scale
Interval -1.27 to -1.05
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 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.
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).
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=536 Participants
Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily
|
Matching Placebo Tablets
n=537 Participants
Matching placebo tablets, 2 tablets four times daily
|
|---|---|---|
|
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
-7 = A very great deal worse
|
0 Participants
|
0 Participants
|
|
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
-6 = A great deal worse
|
0 Participants
|
1 Participants
|
|
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
-5 = A good deal worse
|
0 Participants
|
0 Participants
|
|
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
-4 = Moderately worse
|
0 Participants
|
3 Participants
|
|
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
-3 = Somewhat worse
|
6 Participants
|
2 Participants
|
|
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
-2 = A little worse
|
3 Participants
|
10 Participants
|
|
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
-1 = Almost the same, hardly any worse at all
|
2 Participants
|
4 Participants
|
|
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
0 = No change
|
41 Participants
|
64 Participants
|
|
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
1 = Almost the same, hardly any better at all
|
32 Participants
|
47 Participants
|
|
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
2 = A little better
|
85 Participants
|
106 Participants
|
|
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
3 = Somewhat better
|
87 Participants
|
89 Participants
|
|
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
4 = Moderately better
|
88 Participants
|
72 Participants
|
|
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
5 = A good deal better
|
116 Participants
|
92 Participants
|
|
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
6 = A great deal better
|
53 Participants
|
33 Participants
|
|
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
7 = A very great deal better
|
23 Participants
|
13 Participants
|
|
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
Missing
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 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.
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).
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=536 Participants
Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily
|
Matching Placebo Tablets
n=537 Participants
Matching placebo tablets, 2 tablets four times daily
|
|---|---|---|
|
OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms
1 = Not important
|
19 Participants
|
25 Participants
|
|
OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms
2 = Slightly important
|
31 Participants
|
51 Participants
|
|
OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms
3 = Somewhat important
|
48 Participants
|
44 Participants
|
|
OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms
4 = Moderately important
|
55 Participants
|
49 Participants
|
|
OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms
5 = Important
|
174 Participants
|
153 Participants
|
|
OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms
6 = Very important
|
138 Participants
|
118 Participants
|
|
OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms
7 = Extremely important
|
31 Participants
|
32 Participants
|
|
OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms
Missing
|
40 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: 7 daysPopulation: 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.
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).
Outcome measures
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=484 Participants
Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily
|
Matching Placebo Tablets
n=452 Participants
Matching placebo tablets, 2 tablets four times daily
|
|---|---|---|
|
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
1 = Not important
|
18 Participants
|
22 Participants
|
|
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
2 = Slightly important
|
29 Participants
|
48 Participants
|
|
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
3 = Somewhat important
|
47 Participants
|
40 Participants
|
|
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
4 = Moderately important
|
55 Participants
|
49 Participants
|
|
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
5 = Important
|
169 Participants
|
151 Participants
|
|
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
6 = Very important
|
136 Participants
|
112 Participants
|
|
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
7 = Extremely important
|
30 Participants
|
30 Participants
|
Adverse Events
Sodium Alginate Double Action Chewable Tablets
Matching Placebo Tablets
Serious adverse events
| Measure |
Sodium Alginate Double Action Chewable Tablets
n=549 participants at risk
Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily
|
Matching Placebo Tablets
n=550 participants at risk
Matching placebo tablets, 2 tablets four times daily
|
|---|---|---|
|
Gastrointestinal disorders
Gastro-oesophageal reflux disease
|
0.18%
1/549 • Number of events 1 • Up to 8 days, from after the first dose of IMP until no later than the day of the last dose of IMP +1
|
0.00%
0/550 • Up to 8 days, from after the first dose of IMP until no later than the day of the last dose of IMP +1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place