Dyspepsia, Gastroesophageal Reflux Disease
Conditions
Keywords
Gastroesophageal Reflux Disease, GERD, Dyspepsia, Indigestion, Heartburn, Acid reflux, Compound Sodium Alginate Double Action Chewable Tablets, Gaviscon Double Action Tablets
Brief summary
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).
Interventions
DRUGCompound Sodium Alginate Double Action Chewable Tablets
2 tablets four times daily
2 tablets four times daily
Sponsors
Reckitt Benckiser Healthcare (UK) Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Current evidence of symptomatic GERD in accord with the Montreal definition. * Patients must have had troublesome heartburn and/or regurgitation (with or without dyspepsia symptoms) of at least mild or moderate intensity on at least 5 days during the week before the start of screening.
Exclusion criteria
* Patients who have a history of drug, solvent or alcohol abuse. * 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 classification grades C-D), Barrett's oesophagus, 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 gastrointestinal bleeding (hematochezia or hematemesis) within 3 months prior to the study, and severe diseases of other major body systems. * Patients who were observed at screening to have a hiatus hernia with a diameter which exceeds 3 cm. * Patients who have taken anti-cholinesterase drugs, traditional Chinese medicines for treating gastrointestinal disease, ulcermin or misoprostol preparations within 7 days prior to screening or throughout the study. * Patients who have taken proton pump inhibitors (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 (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 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. * Any previous history of allergy or known intolerance to any of the investigational medicinal products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Reflux Disease Questionnaire (RDQ) Scores for the GERD Dimension | 7 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in RDQ Scores for the Heartburn Dimension | 7 days | 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. |
| Change From Baseline in RDQ Scores for the Regurgitation Dimension | 7 days | 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. |
| Change From Baseline in RDQ Scores for the Dyspepsia Dimension | 7 days | 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. |
| OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms | 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 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). |
| 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 days | 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). |
| 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 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). |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sodium Alginate Double Action Chewable Tablets Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily | 549 |
| Matching Placebo Tablets Matching placebo tablets, 2 tablets four times daily | 550 |
| Total | 1,099 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 5 |
| Overall Study | Lack of Efficacy | 0 | 3 |
| Overall Study | Lost to Follow-up | 11 | 9 |
| Overall Study | No further need of investigational product | 1 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 7 |
Baseline characteristics
| Characteristic | Sodium Alginate Double Action Chewable Tablets | Matching Placebo Tablets | Total |
|---|---|---|---|
| Age, Continuous | 45.0 Years STANDARD_DEVIATION 11.81 | 44.8 Years STANDARD_DEVIATION 11.84 | 44.9 Years STANDARD_DEVIATION 11.82 |
| Race/Ethnicity, Customized Afro-Caribbean | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 548 Participants | 550 Participants | 1098 Participants |
| Race/Ethnicity, Customized Caucasian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 549 participants | 550 participants | 1099 participants |
| Sex: Female, Male Female | 280 Participants | 262 Participants | 542 Participants |
| Sex: Female, Male Male | 269 Participants | 288 Participants | 557 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 549 | 0 / 550 |
| other Total, other adverse events | 0 / 549 | 0 / 550 |
| serious Total, serious adverse events | 1 / 549 | 0 / 550 |
Outcome results
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.
Time frame: 7 days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sodium Alginate Double Action Chewable Tablets | Change From Baseline in Reflux Disease Questionnaire (RDQ) Scores for the GERD Dimension | -1.27 score on a scale |
| Matching Placebo Tablets | Change From Baseline in Reflux Disease Questionnaire (RDQ) Scores for the GERD Dimension | -1.06 score on a scale |
p-value: <0.000195% CI: [-0.31, -0.11]Mixed Models Analysis
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.
Time frame: 7 days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sodium Alginate Double Action Chewable Tablets | Change From Baseline in RDQ Scores for the Dyspepsia Dimension | -0.98 score on a scale |
| Matching Placebo Tablets | Change From Baseline in RDQ Scores for the Dyspepsia Dimension | -0.80 score on a scale |
p-value: 0.000495% CI: [-0.29, -0.08]Mixed Models Analysis
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.
Time frame: 7 days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sodium Alginate Double Action Chewable Tablets | Change From Baseline in RDQ Scores for the Heartburn Dimension | -1.16 score on a scale |
| Matching Placebo Tablets | Change From Baseline in RDQ Scores for the Heartburn Dimension | -0.95 score on a scale |
p-value: 0.000195% CI: [-0.32, -0.1]Mixed Models Analysis
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.
Time frame: 7 days
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Sodium Alginate Double Action Chewable Tablets | Change From Baseline in RDQ Scores for the Regurgitation Dimension | -1.37 score on a scale |
| Matching Placebo Tablets | Change From Baseline in RDQ Scores for the Regurgitation Dimension | -1.16 score on a scale |
p-value: 0.000495% CI: [-0.32, -0.09]Mixed Models Analysis
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).
Time frame: 7 days
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Matching Placebo Tablets | 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 |
| Matching Placebo Tablets | 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 | 22 Participants |
| Matching Placebo Tablets | 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 | 48 Participants |
| Matching Placebo Tablets | 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 | 40 Participants |
| Matching Placebo Tablets | 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 | 49 Participants |
| Matching Placebo Tablets | 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 | 151 Participants |
| Matching Placebo Tablets | 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 | 112 Participants |
p-value: 0.0503Wilcoxon (Mann-Whitney)
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).
Time frame: 7 days
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms | Missing | 40 Participants |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Matching Placebo Tablets | OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms | Missing | 65 Participants |
| Matching Placebo Tablets | OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms | 1 = Not important | 25 Participants |
| Matching Placebo Tablets | OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms | 2 = Slightly important | 51 Participants |
| Matching Placebo Tablets | OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms | 3 = Somewhat important | 44 Participants |
| Matching Placebo Tablets | OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms | 4 = Moderately important | 49 Participants |
| Matching Placebo Tablets | OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms | 5 = Important | 153 Participants |
| Matching Placebo Tablets | OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms | 6 = Very important | 118 Participants |
| Matching Placebo Tablets | OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms | 7 = Extremely important | 32 Participants |
p-value: 0.0433Wilcoxon (Mann-Whitney)
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).
Time frame: 7 days
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Sodium Alginate Double Action Chewable Tablets | 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 |
| Matching Placebo Tablets | 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 | 1 Participants |
| Matching Placebo Tablets | 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 |
| Matching Placebo Tablets | 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 | 47 Participants |
| Matching Placebo Tablets | 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 | 1 Participants |
| Matching Placebo Tablets | 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 | 92 Participants |
| Matching Placebo Tablets | 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 |
| Matching Placebo Tablets | 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 | 106 Participants |
| Matching Placebo Tablets | 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 | 3 Participants |
| Matching Placebo Tablets | 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 | 13 Participants |
| Matching Placebo Tablets | 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 | 2 Participants |
| Matching Placebo Tablets | 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 | 89 Participants |
| Matching Placebo Tablets | 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 | 10 Participants |
| Matching Placebo Tablets | 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 | 33 Participants |
| Matching Placebo Tablets | 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 | 4 Participants |
| Matching Placebo Tablets | 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 | 72 Participants |
| Matching Placebo Tablets | 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 | 64 Participants |
p-value: <0.0001Wilcoxon (Mann-Whitney)