The efficacy and safety of mosapride compared with domperidone in Parkinson's disease with gastroparesis; A randomized, double blind, double dummy study

Phase 3

• Conditions: Gastroparesis in Parkinsons disease; Gastroparesis; Gastric emptying time; Domperidone; Prokinetic; Parkinsons disease; Mosapride

• Registration Number: TCTR20220821001
• Lead Sponsor: Faculty of Medicine, Prince of Songkla University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-21
• Study Completion: 2023-05-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Parkinson's disease patients with clinical suspected gastroparesis including nausea, vomiting, abdominal distension, early satiety, abdominal pain
or whom taking prokinetic due to these symptoms

Exclusion Criteria

Severe dysphagia or mastication problems causing eating problems
Underlying diseases of diabetes mellitus, hypothyroidism, connective tissue disease, chronic kidney disease (eGFR < 30 ml/min/1.73mm2)
History of stomach or proximal small bowel surgery
History of polymorphic ventricular tachycardia
QTc prolongation from ECG (QTc > 450 msec for male or > 470 msec for female
History of egg allergy (used for gastric scintigraphy test)
History of mosapride or domperidone allergy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gastric emptying half time 4 weeks Gastric scintigraphy

Secondary Outcome Measures

Name	Time	Method
Gastric retention at 1st, 2nd, 4th hour 4 weeks Percent,Gastroparesis cardinal symptom index 4 weeks Point,GERD questionnaire 4 weeks Point,Patient assessment of constipation symptoms questionnaire 4 weeks Point,Unified Parkinsons disease rating scale 4 weeks Point,Side effect 2 and 4 weeks Frequency ,QTc interval 4 weeks msec