Ignite Creation Date:
2025-12-24 @ 11:00 PM
Ignite Modification Date:
2025-12-25 @ 8:29 PM
Study NCT ID:
NCT04464369
Status:
COMPLETED
Last Update Posted:
2020-07-09
First Post:
2016-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Study Overview
Official Title:
Functional Dyspepsia: Validation of a Questionnaire for Symptom Assessment in Patients Suffering From Post Prandial Distress Syndrome (Functional Dyspepsia) :
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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
1. \- Mild (Symptom is present but is not bothersome)
2. \- Moderate (Symptom is present and bothersome)
3. \- Severe (Symptom interferes with normal activity)
4. \- 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
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
1. \- Mild (Symptom is present but is not bothersome)
2. \- Moderate (Symptom is present and bothersome)
3. \- Severe (Symptom interferes with normal activity)
4. \- 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: