A Randomized, Double Blind, Placebo Controlled, Crossover Trial of Clebopride vs Placebo in the Treatment of Clinically Suspected Rumination Syndrome.

Conditions

Rumination Syndrome

Brief summary

The patients perceived overall treatment evaluation (OTE), which will be obtained using a Likert score between -4 and +4.

Detailed description

The overall symptom severity (OSS) compared between both treatment periods . The OSS will be filled out at the end of each treatment period, and numbers will be compared between the two treatment periods., The difference between receiving clebopride and placebo in the number of symptom events identified by the patient during HRiM. Patients will have to push a symptom marker during the HRiM measurement. Different markers will be used for different symptoms, Number of flow events during HRiM., EGJ pressure during HRiM. The averages after a meal period will be compared between placebo and clebopride condition, Number of TLESRs. The number of TLESRs will be compared between placebo and clebopride condition, Number of events with increased Intra-gastric pressure, Daily Symptom Diary Leuven Postprandial Distress Scale (LPDS) diary with additional question concerning retrograde bolus flow, Symptom severity at week 2 (PAGI-SYM), Quality of life at week 2 (PAGI-QOL)

Related papers

No related papers found yet.

Interventions

DRUGPlacebo tablet manufactured by Laboratoria Wolfs

DRUGingredients per tablet (488mg): Lactose monohydrate 320mg/tablet Carmellose sodium 10mg/tablet Corn starch 70mg/tablet Cellulose microcrystalline 55mg/tablet Silicium dioxide anhydrous 20mg/tablet Magnesium stearate 13mg/tablet

DRUGMOTILEX 0

DRUG5 mg compresse

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The patients perceived overall treatment evaluation (OTE), which will be obtained using a Likert score between -4 and +4.	—

Secondary

Measure	Time frame
The overall symptom severity (OSS) compared between both treatment periods . The OSS will be filled out at the end of each treatment period, and numbers will be compared between the two treatment periods., The difference between receiving clebopride and placebo in the number of symptom events identified by the patient during HRiM. Patients will have to push a symptom marker during the HRiM measurement. Different markers will be used for different symptoms, Number of flow events during HRiM., EGJ pressure during HRiM. The averages after a meal period will be compared between placebo and clebopride condition, Number of TLESRs. The number of TLESRs will be compared between placebo and clebopride condition, Number of events with increased Intra-gastric pressure, Daily Symptom Diary Leuven Postprandial Distress Scale (LPDS) diary with additional question concerning retrograde bolus flow, Symptom severity at week 2 (PAGI-SYM), Quality of life at week 2 (PAGI-QOL)	—

Measure

Time frame

The overall symptom severity (OSS) compared between both treatment periods . The OSS will be filled out at the end of each treatment period, and numbers will be compared between the two treatment periods., The difference between receiving clebopride and placebo in the number of symptom events identified by the patient during HRiM. Patients will have to push a symptom marker during the HRiM measurement. Different markers will be used for different symptoms, Number of flow events during HRiM., EGJ pressure during HRiM. The averages after a meal period will be compared between placebo and clebopride condition, Number of TLESRs. The number of TLESRs will be compared between placebo and clebopride condition, Number of events with increased Intra-gastric pressure, Daily Symptom Diary Leuven Postprandial Distress Scale (LPDS) diary with additional question concerning retrograde bolus flow, Symptom severity at week 2 (PAGI-SYM), Quality of life at week 2 (PAGI-QOL)

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Countries

Belgium

Outcome results

None listed