Clinical Trial Results:
Functional Dyspepsia: validation of a questionnaire for symptom assessment in patients suffering from Postprandial Distress Syndrome (Functional Dyspepsia): assessment of sensitivity to change in PDS symptom severity in an interventional study
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Summary
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EudraCT number |
2012-004296-39 |
Trial protocol |
BE |
Global end of trial date |
08 Jan 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Apr 2021
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First version publication date |
18 Apr 2021
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Other versions |
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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 |
LPDSItopride
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
UZLeuven
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Sponsor organisation address |
Herestraat 49, Leuven, Belgium, 3000
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Public contact |
Jan Tack, UZLeuven, 32 16344225, jan.tack@uzleuven.be
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Scientific contact |
Florencia Carbone, UZLeuven, 32 16330816, florencia.carbone@kuleuven.be
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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 |
29 Nov 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Jan 2015
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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 |
To validate a PRO in line with the FDA guideline, according to early EMA input and with close adherence with DSSI instrument that showed responsiveness in a US phase II.
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Protection of trial subjects |
not applicable
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Sep 2013
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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 |
Belgium: 100
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Worldwide total number of subjects |
100
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EEA total number of subjects |
100
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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 |
6
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85 years and over |
0
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Recruitment
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Recruitment details |
Consecutive out-patients diagnosed with postprandial distress syndrome according to Rome III criteria at eleven gastroenterology practices in Belgium were eligible for the study. Both French and Dutch speaking patients between the ages of 18 and 70 years were included. | |||||||||
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Pre-assignment
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Screening details |
patients were included if they were confirmed to suffer from active postprandial distress syndrome as per LPDS scoring system during the 2 weeks eligibility period. This required the presence of at least moderate (score 2) postprandial fullness and/or early satiation symptoms on at least 4 days during the 2 weeks eligibility period. | |||||||||
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Period 1
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Period 1 title |
treatment period (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 |
Subject, Investigator, Monitor, Carer, Assessor | |||||||||
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Arms
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Are arms mutually exclusive |
No
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Arm title
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itopride | |||||||||
Arm description |
Itopride (100 mg three times daily) | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
itopride
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Itopride 100 mg, three times daily
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Arm title
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placebo | |||||||||
Arm description |
placebo three times daily | |||||||||
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 |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
placebo tablet, three times daily
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Baseline characteristics reporting groups [1]
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Reporting group title |
treatment period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Notes [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same. Justification: Statistical analysis was performed after inclusion of the first 60 patients. |
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End points reporting groups
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Reporting group title |
itopride
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Reporting group description |
Itopride (100 mg three times daily) | ||
Reporting group title |
placebo
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Reporting group description |
placebo three times daily | ||
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End point title |
Validation of the Leuven Postprandial Distress Scale | ||||||||||||
End point description |
The LPDS diary, comprising eight symptoms with verbal descriptors rated for severity
(0–4), was derived from focus groups and cognitive debriefing. It was used in a
2-week run-in, 8-week double-blind placebo-controlled trial of itopride 100 mg t.d.s.
Results in 60 patients, with concealed treatment allocation, were used to analyse
LPDS content validity, consistency, reliability and responsiveness. Patients also filled
out Patient Assessment of Gastrointestinal Symptoms (PAGI-SYM), Nepean Dyspepsia
Index, overall treatment evaluation and overall symptom severity questionnaires.
Construct validity was evaluated by known-group analyses and by correlating LPDS
with these additional questionnaires. Minimum Clinically Important Difference was
determined from threshold changes in anchor questionnaires.
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End point type |
Primary
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End point timeframe |
The end of treatment measurements (visit 6 of the trial) were used for responsiveness.
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| Notes [1] - the code was not broken for the analysis of this study aim. Analysis was performed on total of 60 pt [2] - the code was not broken for the analysis of this study aim. Analysis was performed on total of 60 pt |
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Statistical analysis title |
MINIMUM CLINICALLY IMPORTANT DIFFERENCE | ||||||||||||
Statistical analysis description |
The minimum clinically important difference was
determined for each anchor at both visits 4 and 6 by
regressing the change between visit 2 and visit 4 or 6 in
the postprandial distress syndrome domain of the LPDS
(dependent variable) on the corresponding change in an
anchor variable (independent variable).
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Comparison groups |
placebo v itopride
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Number of subjects included in analysis |
120
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Analysis specification |
Pre-specified
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Analysis type |
superiority [3] | ||||||||||||
P-value |
= 0 [4] | ||||||||||||
Method |
Regression, Linear | ||||||||||||
Confidence interval |
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| Notes [3] - The slope of this regression model defines the minimum clinically important difference, since it estimates how much the postprandial distress syndrome changes within patients, on average, per unit (one point) change in the external measure. Scatterplots of dependent and independent variables were examined to check that there is no clear departure from the assumption of linearity. [4] - P value is not applicable. The study aim was the validation of a questionnaire. The code was not broken for this analysis. Statistical nalysis is performed on total of 60 subjects. |
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Adverse events information [1]
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Timeframe for reporting adverse events |
For each individual, corresponds to timeframe of study participation (from signing of informed consent until last visit).
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Adverse event reporting additional description |
The most common possible adverse reactions to the study drug (itopride
or placebo, as the code was not broken) were headache (13%), insomnia (5%) and dizziness (3%).
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Assessment type |
Non-systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
23
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| Frequency threshold for reporting non-serious adverse events: 5% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: The most common possible adverse reactions to the study drug (itopride or placebo, as the code was not broken) were headache (13%), insomnia (5%) and dizziness (3%). |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
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. | |||
| This trial was set up to investigate if The Leuven Postprandial Distress Scale (LPDS) is a sensitive and reliable patient-reported outcome instrument to assess symptoms in the functional dyspepsia/postprandial distress syndrome. | |||
Online references |
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| http://www.ncbi.nlm.nih.gov/pubmed/27518319 |
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