Clinical Trial Results:
A multicentre, randomised, double-blind, two arm, parallel group, placebo controlled, pilot study to assess the effect of Gaviscon Advance as add-on therapy in GORD patients with inadequate response to once daily proton pump inhibitor treatment.
Summary
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EudraCT number |
2011-005486-21 |
Trial protocol |
DK DE |
Global end of trial date |
14 Nov 2013
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Jun 2017
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First version publication date |
11 Jun 2017
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GA1102
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Reckitt Benckiser Healthcare (UK) Ltd
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Sponsor organisation address |
Dansom Lane, Hull, United Kingdom, HU8 7DS
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Public contact |
Medical Director, Gastroenterology, Clearcut Clinical Consulting Ltd., +44 7813731925,
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Scientific contact |
Medical Director, Gastroenterology, Clearcut Clinical Consulting Ltd., +44 7813731925,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
09 Apr 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Nov 2013
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Nov 2013
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of the study is to assess the efficacy of Gaviscon Advance (an aniseed flavoured oral suspension) compared with placebo in the suppression of GORD symptoms in patients whose symptoms are inadequately controlled by once daily PPI therapy alone.
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Protection of trial subjects |
This study was conducted in accordance with ICH Good Clinical Practice and the ethical principles contained within the Declaration of Helsinki, as referenced in EU Directive 2001/20/EC.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Jun 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 74
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Country: Number of subjects enrolled |
Germany: 62
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Worldwide total number of subjects |
136
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EEA total number of subjects |
136
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
94
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From 65 to 84 years |
41
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85 years and over |
1
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Recruitment
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Recruitment details |
This study was multicentre and multinational with 8 active centres in Denmark and Germany. | ||||||||||||||||||
Pre-assignment
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Screening details |
A total of 195 patients were screened for the study, of which 59 patients were screen failures and 136 patients were randomized. | ||||||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||
Roles blinded |
Investigator, Subject | ||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Gaviscon Advance | ||||||||||||||||||
Arm description |
Gaviscon Advance 10 ml taken 4 times a day for 7 days. | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Gaviscon Advance
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
10 ml taken 4 times a day for 7 days.
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Arm title
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Placebo | ||||||||||||||||||
Arm description |
Placebo 10 ml taken 4 times a day for 7 days. | ||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral suspension
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Routes of administration |
Oral use
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Dosage and administration details |
10 ml taken 4 times a day for 7 days.
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Baseline characteristics reporting groups
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Reporting group title |
Gaviscon Advance
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Reporting group description |
Gaviscon Advance 10 ml taken 4 times a day for 7 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo 10 ml taken 4 times a day for 7 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Gaviscon Advance
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Reporting group description |
Gaviscon Advance 10 ml taken 4 times a day for 7 days. | ||
Reporting group title |
Placebo
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Reporting group description |
Placebo 10 ml taken 4 times a day for 7 days. |
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End point title |
Change from Baseline to Post-Dose in HRDQ score (heartburn and regurgitation only) | |||||||||||||||
End point description |
Intention to treat (ITT) population: All patients who were recruited to the study and had at least 1 day of complete HRDQ (Heartburn and Dyspesia) data post-dosing. This population was used for summaries of efficacy and baseline data. Two patients with no post-baseline HRDQ data were excluded from ITT population.
Heartburn Regurgitation and Dyspepsia Questionnaire (HRDQ): The HRDQ symptom severity was recorded a 0 (no symptoms), 1 (mild), 2 (moderate) and 3 (severe) and the frequency was scored as 0 (none), 1 (once), 2 (twice), 3 (thrice), 4 (4 or 5 times), 5 (6 – 10 times) and 6 (more than 10 times or constant). In addition, the HRDQ questionnaire required patients to record the duration of their symptoms and whether or not they had experienced night-time symptoms.
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End point type |
Primary
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End point timeframe |
From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
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Statistical analysis title |
Change in HRDQ Score (heartburn and regurgitation) | |||||||||||||||
Statistical analysis description |
Intention to treat (ITT) population: All patients who were recruited to the study and had at least 1 day of complete HRDQ (Heartburn and Dyspesia) data post-dosing. This population was used for summaries of efficacy and baseline data.
Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
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Comparison groups |
Gaviscon Advance v Placebo
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Number of subjects included in analysis |
134
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.0321 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Confidence interval |
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End point title |
Change in HRDQ Score – Dyspepsia | |||||||||||||||
End point description |
ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
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End point type |
Secondary
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End point timeframe |
From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
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Statistical analysis title |
Change in HRDQ Score – Dyspepsia | |||||||||||||||
Statistical analysis description |
ITT population.
Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
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Comparison groups |
Gaviscon Advance v Placebo
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Number of subjects included in analysis |
134
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.4845 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Confidence interval |
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End point title |
Change in HRDQ Score – Heartburn | |||||||||||||||
End point description |
ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
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End point type |
Secondary
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End point timeframe |
From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
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Statistical analysis title |
Change in HRDQ Score – Heartburn | |||||||||||||||
Statistical analysis description |
Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
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Comparison groups |
Gaviscon Advance v Placebo
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Number of subjects included in analysis |
134
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.0244 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Confidence interval |
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End point title |
Change in HRDQ Score – Regurgitation | |||||||||||||||
End point description |
ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
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End point type |
Secondary
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End point timeframe |
From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
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Statistical analysis title |
Change in HRDQ Score – Regurgitation | |||||||||||||||
Statistical analysis description |
Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
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Comparison groups |
Gaviscon Advance v Placebo
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Number of subjects included in analysis |
134
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.1045 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Confidence interval |
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End point title |
Change From Baseline to Post-Dose in Number of Days with Night Time Symptoms | |||||||||||||||
End point description |
ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
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End point type |
Secondary
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End point timeframe |
From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
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Statistical analysis title |
Change in Number of Days with Night Time Symptoms | |||||||||||||||
Comparison groups |
Gaviscon Advance v Placebo
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Number of subjects included in analysis |
134
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.0083 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Confidence interval |
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End point title |
Change From Baseline to Post-Dose in Duration of Symptoms (HRDQ) | |||||||||||||||
End point description |
ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
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End point type |
Secondary
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End point timeframe |
From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
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Statistical analysis title |
Change in Duration of Symptoms | |||||||||||||||
Comparison groups |
Gaviscon Advance v Placebo
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Number of subjects included in analysis |
132
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.6494 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Confidence interval |
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End point title |
Change From Baseline to Post-Dose in Frequency of Heartburn (HRDQ Score) | |||||||||||||||
End point description |
ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
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End point type |
Secondary
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End point timeframe |
From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
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Statistical analysis title |
Change in Duration of Symptoms | |||||||||||||||
Statistical analysis description |
Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
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Comparison groups |
Gaviscon Advance v Placebo
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Number of subjects included in analysis |
134
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.0114 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Confidence interval |
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End point title |
Change From Baseline to Post-Dose in Frequency of Regurgitation (HRDQ Score) | |||||||||||||||
End point description |
ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
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End point type |
Secondary
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End point timeframe |
From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
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Statistical analysis title |
Change in Frequency of Regurgitation | |||||||||||||||
Statistical analysis description |
Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
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Comparison groups |
Gaviscon Advance v Placebo
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Number of subjects included in analysis |
134
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.0364 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Confidence interval |
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End point title |
Change From Baseline to Post-Dose in Frequency of Dyspepsia (HRDQ Score) | |||||||||||||||
End point description |
ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
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End point type |
Secondary
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End point timeframe |
From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
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Statistical analysis title |
Change in Frequency of Dyspepsia | |||||||||||||||
Statistical analysis description |
Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
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Comparison groups |
Placebo v Gaviscon Advance
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Number of subjects included in analysis |
134
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.1857 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Confidence interval |
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End point title |
Change From Baseline to Post-Dose in ReQuest GI Scores | |||||||||||||||
End point description |
ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
ReQuest GI is a self-assessed, dimension-orientated scale designed to evaluate treatment response on a daily basis in patients suffering from GORD. The scale assesses 4 dimensions of GORD. Intensity is measured on a 100-mm VAS and frequency on a 7-point Likert scale (0 to 10 times/constant per day). The range of the ReQuest™ GI score is from 0 reflecting no symptoms to 30.77 reflecting the highest severity/frequency of symptoms.
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End point type |
Secondary
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End point timeframe |
From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
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Statistical analysis title |
Change in ReQuest GI scores | |||||||||||||||
Statistical analysis description |
Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
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Comparison groups |
Gaviscon Advance v Placebo
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Number of subjects included in analysis |
119
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.3138 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Confidence interval |
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End point title |
Change From Baseline to Post-Dose in the Patient Satisfaction Score | |||||||||||||||
End point description |
ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
Patient Satisfaction Visual Analogue Scale (VAS): Patient satisfaction with IMP in controlling their symptoms was assessed in response to the question: 'Thinking back over the past 7 days and the medication you received, how satisfied are you with the control of your symptoms?' Patients drew a perpendicular line on a 100-mm VAS, with anchors at 0 = 'Very Satisfied' and 100 = 'Very Dissatisfied' to reflect their satisfaction.
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End point type |
Secondary
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End point timeframe |
From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
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Statistical analysis title |
Change in Patient Satisfaction Score | |||||||||||||||
Comparison groups |
Gaviscon Advance v Placebo
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Number of subjects included in analysis |
131
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.1959 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Confidence interval |
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End point title |
Change From Baseline in Number of Symptom-Free Days (HRDQ) | |||||||||||||||
End point description |
ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
A symptom-free day is defined as a day where the respective symptoms: heartburn, regurgitation and dyspepsia (all derived from the HRDQ) had a value for frequency of 0.
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End point type |
Secondary
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End point timeframe |
From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
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Statistical analysis title |
Change Number of Symptom Free Days (HRDQ) | |||||||||||||||
Statistical analysis description |
Two patients with no post-baseline HRDQ data available is exclusion from Intention-to-treat population.
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Comparison groups |
Gaviscon Advance v Placebo
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Number of subjects included in analysis |
134
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.9363 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Confidence interval |
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End point title |
Change From Baseline in Number of Symptom-Free Days (ReQuest) | |||||||||||||||
End point description |
ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
ReQuest GI is a self-assessed, dimension-orientated scale designed to evaluate treatment response on a daily basis in patients suffering from GORD. The scale assesses 4 dimensions of GORD. Intensity is measured on a 100-mm VAS and frequency on a 7-point Likert scale (0 to 10 times/constant per day). The range of the ReQuest™ GI score is from 0 reflecting no symptoms to 30.77 reflecting the highest
severity/frequency of symptoms.
A symptom-free day is defined as a day where the respective symptoms: acid complaints, upper abdominal/stomach complaints, lower abdominal/digestive complaints and nausea (all derived from ReQuest™) had a value for frequency of 0.
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End point type |
Secondary
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End point timeframe |
From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
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Statistical analysis title |
Change in Number of Symptom Free Days (ReQuest) | |||||||||||||||
Comparison groups |
Gaviscon Advance v Placebo
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Number of subjects included in analysis |
130
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||||||||
P-value |
= 0.8195 | |||||||||||||||
Method |
ANCOVA | |||||||||||||||
Confidence interval |
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End point title |
Change from baseline to post-dose in whether the patient had any night-time symptoms (HRDQ) | ||||||||||||||||||
End point description |
ITT population. Two patients with no post-baseline HRDQ data were excluded from ITT population.
-1 = Improvement in night time symptoms (i.e. patients had night-time symptoms at baseline and no night time symptoms post-dose)
0 = Either night-time symptoms at baseline and post-dose or no night-time symptoms at baseline and post-dose
1 = Deterioration in night-time symptoms (i.e. patients had no night-time symptoms at baseline and night time symptoms post-dose)
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End point type |
Secondary
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End point timeframe |
From Visit 2 (Day 0-Baseline) to Visit 3 (Day 8, 9 or 10)
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Up to Visit 3
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Adverse event reporting additional description |
There were no deaths, other SAEs in this study.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1
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Reporting groups
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Reporting group title |
Gaviscon Advance
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Reporting group description |
Gaviscon Advance 10 ml taken 4 times a day for 7 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Placebo 10 ml taken 4 times a day for 7 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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31 Jul 2012 |
1. Clarification of ambiguities in the inclusion criteria
2. Change to SAE reporting procedures according to latest RB SOP
3. Increase in the number of potential sites in Denmark
4. Set up of sites in Germany |
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14 Nov 2012 |
1. Clarification of ambiguities in the inclusion/exclusion criteria at the request of the German CA (BfArM) and the German leading EC.
2. Change in the procedure for reporting incorrect dosing and pregnancy in accordance with the latest RB protocol template (which complied with regulatory requirements). |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |