Functional DyspepsiaPhase 4NCT04464369
Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial
A Phase 4 study testing itopride in people with Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
No instrument is available for the assessment of the symptoms in patients suffering from functional dyspepsia - postprandial distress syndrome patients - PDS. Indeed PDS is an unmet clinical need in drug development. To do so, the development of suitable endpoints for its efficacy evaluation is indicated. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- itopride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2013to Nov 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are eligible for randomisation if all of the following criteria are met:
- At visit 1:
- Patients with FD diagnosis as per Rome III classification (Negative gastroscopy valid for the last 6 months)
- Patients with PDS diagnosis as per Rome III by Rome III questionnaire
- Patients must provide witnessed written informed consent prior to any study procedures being performed
- Patients who are HP negative provided that they where not eradicated during the last 3 months.
Show all 11Show fewer
- Patients aged between 18 and 70 years inclusive
- Male or female patients
- Patients who are capable to understand the study and the questionnaires, and to comply with the study requirements
- At visit 2:
- Patients suffering from active PDS (Rome III) as per LPDS scoring system (See Focus Group study) during 2 weeks before randomisation
Who cannot join
- Patients are excluded from the study if any of the following criteria are met:
- At visit 1:
- Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
- Patients with any major psychiatric disorder (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years. Patients suffering from one psychiatric trouble stabilised for six month by the administration of one drug (Not amitryptiline) are acceptable.
- Females who are pregnant or lactating.
- Patients presenting with predominant symptoms of irritable bowel syndrome (IBS)
Show all 23Show fewer
- Patient with predominant symptoms of GERD according to GERD questionnaire (Two "yes" answer to question 21)
- Patients suffering from diabetes type 1 or type 2.
- Patients taking medications for the treatment of their upper digestive symptoms: prokinetics and acid suppressants (PPIs). A wash-out is allowed if medically indicated (E.g.: lack of efficacy or side-effects). This wash-out is minimum two weeks for the patients taking PPIs*
- Patients with well-known hypersensitivity to gastroprokinetic drugs.
- Patients with confirmed gastro-intestinal disease.
- Patients with former digestive surgery affecting the gut motility.
- Many patients take PPIs in absence of efficient treatment. In the literature, PPIs appear effective in patients suffering from substantial concomitant heartburn that is not allowed for inclusion in this study. In this context, a medically indicated wash-out and the proposal of a therapeutic alternative is appropriate.
- 6. Patients presenting symptoms of EPS several times a week according to Rome III questionnaire (score 5 on question 10) at visit 2
- 7. Patients presenting daily symptoms of CIN on Rome III questionnaire (score 6 on question 6 or score 5 on question 9) at visit 2
- 8. Patients presenting daily symptoms of Excessive belching according to Rome III questionnaire (score 6 on question 19) at visit 2
- At visit 2:
- Patients presenting symptoms of EPS several times a week according to Rome III questionnaire (score 5 on question 10)
- Patients presenting daily symptoms of CIN on Rome III questionnaire (score 6 on question 6 or score 5 on question 9 )
- Patients presenting daily symptoms of Excessive belching according to Rome III questionnaire (score 6 on question 19)
- Patients presenting predominant GERD according to GERD questionnaire (Two"yes" answer to question 21)
- Patients taking prohibited medications.
- Patients affected by concomitant disease responsible for digestive symptoms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Dyspepsia: Validation of a Questionnaire for Symptom Assessment in Patients Suffering From Post Prandial Distress Syndrome (Functional Dyspepsia) :
No instrument is available for the assessment of the symptoms in patients suffering from functional dyspepsia - postprandial distress syndrome patients - PDS. Indeed PDS is an unmet clinical need in drug development. To do so, the development of suitable endpoints for its efficacy evaluation is indicated.
After interviews of patients suffering from PDS (Focus groups) and identification of the emerging symptoms a draft version of the Leuven Postprandial Distress Scale (LPDS) questionnaire has been designed. This study will assess the reliability of the scoring rule, the construct validity and ability to detect change of the draft LPDS.
A minimum of 100 PDS patients will be randomised in two arms receiving respectively either Itopride 100 mg tid or Placebo tid during 8 weeks. Patients of both arms will be tested with LPDS using daily diary cards and by anchor questionnaires (PAGI-SYM, OSS, OTE) at baseline and during the study drug administration period.
Read the detailed description
2.3 Study design After review of the literature, identification of the intended population (PDS patients with the lowest EPS component), it has been decided that the conceptual framework for the instrument will be based on the motility subscales of DSSI assessing the severity of the symptoms on 5 point Likert Scale (0-4; no symptom, mild, moderate, severe, very severe). After interview of patients suffering from PDS (Focus groups) and identification of the emerging symptoms a draft version of LPDS questionnaire has been designed. This study will assess the reliability of the scoring rule, the construct validity and ability to detect change of the draft LPDS.
A minimum of 100 PDS patients will be randomised in two arms receiving respectively either Itopride 100 mg tid or Placebo tid during 8 weeks. Patients of both arms will be tested with LPDS using daily diary cards and by PAGI-SYM, SF-NDI, OSS, OTE at baseline and during the study drug administration period.
Eligibility (2w) Randomisation Study drug administration (8w)
Group 1 Placebo tid (LPDS, OTE, OSS, PAGI-SYM, SF-NDI) Eligible patients Group 2 Itopride 100 mg tid (LPDS, OTE, OSS, PAGI-SYM, SF-NDI)
4.1 Interventional study for LPDS responsiveness. This study will be a multicentre randomized multiple-assessed, placebo-controlled parallel-group study of Itopride 100 mg tid in PDS. The rationale to use Itopride is the lack of efficient treatment for FD. Itopride was extensively used in FD trials and is prescribed in clinical practice in several parts of the world. The treatment period for evaluation of LPDS responsiveness will be 8 weeks after a 2 week eligibility period.
Patients will assess the severity of their symptoms using the new LPDS questionnaire adapted from the conceptual framework. This will be done through daily paper diaries. Assumingly, the diaries will include ratings of PDS symptoms, EPS symptoms, bloating, nausea and belching. In addition, patients will fill out OSS, PAGI-SYM and SF-NDI questionnaires at the end of the run-in period, and after 2, 4, 6 and 8 weeks of treatment. They will also fill out OTE after 2, 4, 6 and 8 weeks of treatment. (See these different questionnaires and the rationale to use them in annex)
At the end of the study, patients will be proposed to enter an open label period of one month (Itopride 100 mg tid). This open label period is not part of the study and has been associated for the benefit of the patients.
4.2 Assessment of symptom severity
Individual symptom severity (hypothesized for LPDS) will be assessed in daily diaries using a 5-point Likert scale:
0 - No symptom
- - Mild (Symptom is present but is not bothersome)
- - Moderate (Symptom is present and bothersome)
- - Severe (Symptom interferes with normal activity)
- - Very severe (Normal activity is not possible)
Overall symptom severity assessment (OSS) questionnaire (with 1 week recall):
What was the overall severity of your stomach symptoms during the past week? (Please select one answer)
- No symptoms
- Very mild
- Mild
- Moderate
- Severe
- Very severe
Overall Treatment Evaluation (OTE) questionnaire (with 1 week recall):
When thinking about the last week, how have your stomach symptoms have been (compared to your condition before you started this treatment)? (please select one answer)
- Extremely better
- Much better
- Somewhat better
- A little better
- About the same
- A little worse
- Somewhat worse
- Much worse
- Extremely worse
PAGI-SYM and SF-NFI are more complex and described in the literature
- Conditions
- Functional Dyspepsia
- Being tested
- itopride, Placebo
- Keywords
- functional dyspepsia, postprandial distress syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
itoprideDrug
Also called Ganaton
itopride is a gastroprokinetic drug that has previously been evaluated in the treatment of functional dyspepsia and which is available in a number of countries worldwide
PlaceboDrug
placebo pills matching the look and weight of the itopride tablets
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo t.i.d. Receives: Drug: Placebo |
| Itopride | Active comparator | Itopride co 100 mg t.i.d. Receives: Drug: itopride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responsiveness of the LPDS instrument (LPDS vs. PAGI-SYM)
The responsiveness of the LPDS will be evaluated in several ways. The correlation between changes in LPDS scores and changes in the (fullness/early satiation subscales of the) PAGI-SYM.
Measured: 8 weeks
Responsiveness of the LPDS instrument (LPDS vs. PAGI-Qol)
The responsiveness of the LPDS will be evaluated in several ways. The correlation between changes in LPDS scores and changes in the the PAGI-QOL.
Measured: 8 weeks
Responsiveness of the LPDS instrument (LPDS vs. OTE)
Changes in the LPDS scores from baseline to week 2 and week 4 will be correlated with the OTE at week 2 and 4
Measured: 8 weeks
Responsiveness of the LPDS instrument (known-groups validation)
groups of patients will be formed on the basis of changes in OSS ratings over time, and changes in LPDS scores will be compared across these groups and the significance of the difference in mean changes in LPDS will be tested using analysis of variance
Measured: 8 weeks
Secondary outcomes (2)
The reliability of the LPDS instrument
The reliability of the LPDS instrument will be evaluated using internal consistency methods, by computing Cronbach's alpha coefficient from the correlation among the symptom items using data from different time points throughout the study. In addition, the test-retest reliability will be evaluated by correlating scores between days 1 and 4 during the run-in period.
Measured: Week 8
Validity of the LPDS instrument
The construct validity of the LPDS will be tested using the logic of known-groups validity. This approach compares the mean scores from LPDS across groups known to differ on the patient's assessment of OSS and OTE. The significance of the difference in mean LPDS will be tested using analysis-of-variance methods.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study startSep 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tack, M.D., Ph.D., Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464369
- Sponsor's protocol ID
- S54963
- Status last verified
- Jul 2020
- First submitted
- 8 Apr 2016
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Tack J, Talley NJ, Camilleri M, Holtmann G, Hu P, Malagelada JR, Stanghellini V. Functional gastroduodenal disorders. Gastroenterology. 2006 Apr;130(5):1466-79. doi: 10.1053/j.gastro.2005.11.059.
PubMed 16678560
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Dyspepsia: Validation of a Questionnaire for Symptom Assessment in Patients Suffering From Post Prandial Distress Syndrome (Functional Dyspepsia) :
- ClinicalTrials.gov ID
- NCT04464369
- Acronym / sponsor ID
- S54963
- Conditions
- Functional Dyspepsia
- Keywords
- functional dyspepsia, postprandial distress syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 9 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
No instrument is available for the assessment of the symptoms in patients suffering from functional dyspepsia - postprandial distress syndrome patients - PDS. Indeed PDS is an unmet clinical need in drug development. To do so, the development of suitable endpoints for its efficacy evaluation is indicated.
After interviews of patients suffering from PDS (Focus groups) and identification of the emerging symptoms a draft version of the Leuven Postprandial Distress Scale (LPDS) questionnaire has been designed. This study will assess the reliability of the scoring rule, the construct validity and ability to detect change of the draft LPDS.
A minimum of 100 PDS patients will be randomised in two arms receiving respectively either Itopride 100 mg tid or Placebo tid during 8 weeks. Patients of both arms will be tested with LPDS using daily diary cards and by anchor questionnaires (PAGI-SYM, OSS, OTE) at baseline and during the study drug administration period.
Detailed description
2.3 Study design After review of the literature, identification of the intended population (PDS patients with the lowest EPS component), it has been decided that the conceptual framework for the instrument will be based on the motility subscales of DSSI assessing the severity of the symptoms on 5 point Likert Scale (0-4; no symptom, mild, moderate, severe, very severe). After interview of patients suffering from PDS (Focus groups) and identification of the emerging symptoms a draft version of LPDS questionnaire has been designed. This study will assess the reliability of the scoring rule, the construct validity and ability to detect change of the draft LPDS.
A minimum of 100 PDS patients will be randomised in two arms receiving respectively either Itopride 100 mg tid or Placebo tid during 8 weeks. Patients of both arms will be tested with LPDS using daily diary cards and by PAGI-SYM, SF-NDI, OSS, OTE at baseline and during the study drug administration period.
Eligibility (2w) Randomisation Study drug administration (8w)
Group 1 Placebo tid (LPDS, OTE, OSS, PAGI-SYM, SF-NDI) Eligible patients Group 2 Itopride 100 mg tid (LPDS, OTE, OSS, PAGI-SYM, SF-NDI)
4.1 Interventional study for LPDS responsiveness. This study will be a multicentre randomized multiple-assessed, placebo-controlled parallel-group study of Itopride 100 mg tid in PDS. The rationale to use Itopride is the lack of efficient treatment for FD. Itopride was extensively used in FD trials and is prescribed in clinical practice in several parts of the world. The treatment period for evaluation of LPDS responsiveness will be 8 weeks after a 2 week eligibility period.
Patients will assess the severity of their symptoms using the new LPDS questionnaire adapted from the conceptual framework. This will be done through daily paper diaries. Assumingly, the diaries will include ratings of PDS symptoms, EPS symptoms, bloating, nausea and belching. In addition, patients will fill out OSS, PAGI-SYM and SF-NDI questionnaires at the end of the run-in period, and after 2, 4, 6 and 8 weeks of treatment. They will also fill out OTE after 2, 4, 6 and 8 weeks of treatment. (See these different questionnaires and the rationale to use them in annex)
At the end of the study, patients will be proposed to enter an open label period of one month (Itopride 100 mg tid). This open label period is not part of the study and has been associated for the benefit of the patients.
4.2 Assessment of symptom severity
Individual symptom severity (hypothesized for LPDS) will be assessed in daily diaries using a 5-point Likert scale:
0 - No symptom
- - Mild (Symptom is present but is not bothersome)
- - Moderate (Symptom is present and bothersome)
- - Severe (Symptom interferes with normal activity)
- - Very severe (Normal activity is not possible)
Overall symptom severity assessment (OSS) questionnaire (with 1 week recall):
What was the overall severity of your stomach symptoms during the past week? (Please select one answer)
- No symptoms
- Very mild
- Mild
- Moderate
- Severe
- Very severe
Overall Treatment Evaluation (OTE) questionnaire (with 1 week recall):
When thinking about the last week, how have your stomach symptoms have been (compared to your condition before you started this treatment)? (please select one answer)
- Extremely better
- Much better
- Somewhat better
- A little better
- About the same
- A little worse
- Somewhat worse
- Much worse
- Extremely worse
PAGI-SYM and SF-NFI are more complex and described in the literature
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo t.i.d. |
| Itopride | Active comparator | Drug: itoprideItopride co 100 mg t.i.d. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with FD diagnosis as per Rome III classification (Negative gastroscopy valid for the last 6 months)
- Patients with PDS diagnosis as per Rome III by Rome III questionnaire
- Patients must provide witnessed written informed consent prior to any study procedures being performed
- Patients who are HP negative provided that they where not eradicated during the last 3 months.
- Patients aged between 18 and 70 years inclusive
Key exclusion criteria (23 listed)
- Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable for entry into the study
- Patients with any major psychiatric disorder (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years. Patients suffering from one psychiatric trouble stabilised for six month by the administration of one drug (Not amitryptiline) are acceptable.
- Females who are pregnant or lactating.
- Patients presenting with predominant symptoms of irritable bowel syndrome (IBS)
- Patient with predominant symptoms of GERD according to GERD questionnaire (Two "yes" answer to question 21)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| itoprideAlso: Ganatonitopride is a gastroprokinetic drug that has previously been evaluated in the treatment of functional dyspepsia and which is available in a number of countries worldwide | Drug | Itopride |
| Placeboplacebo pills matching the look and weight of the itopride tablets | Drug | Placebo |
Primary outcome
Responsiveness of the LPDS instrument (LPDS vs. PAGI-SYM)
Time frame: 8 weeks
The responsiveness of the LPDS will be evaluated in several ways. The correlation between changes in LPDS scores and changes in the (fullness/early satiation subscales of the) PAGI-SYM.
Responsiveness of the LPDS instrument (LPDS vs. PAGI-Qol)
Time frame: 8 weeks
The responsiveness of the LPDS will be evaluated in several ways. The correlation between changes in LPDS scores and changes in the the PAGI-QOL.
Responsiveness of the LPDS instrument (LPDS vs. OTE)
Time frame: 8 weeks
Changes in the LPDS scores from baseline to week 2 and week 4 will be correlated with the OTE at week 2 and 4
Responsiveness of the LPDS instrument (known-groups validation)
Time frame: 8 weeks
groups of patients will be formed on the basis of changes in OSS ratings over time, and changes in LPDS scores will be compared across these groups and the significance of the difference in mean changes in LPDS will be tested using analysis of variance
2 secondary outcomes
The reliability of the LPDS instrument
Time frame: Week 8
Validity of the LPDS instrument
Time frame: Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Background: PubMed 16678560Tack J, Talley NJ, Camilleri M, Holtmann G, Hu P, Malagelada JR, Stanghellini V. Functional gastroduodenal disorders. Gastroenterology. 2006 Apr;130(5):1466-79. doi: 10.1053/j.gastro.2005.11.059.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Tack, M.D., Ph.D. principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing itopride in people with Functional Dyspepsia, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responsiveness of the LPDS instrument (LPDS vs. PAGI-SYM) (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04464369, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.