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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220821001
Enrollment
60
Registered
2022-08-21
Start date
2022-08-23
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroparesis in Parkinsons disease Gastroparesis Parkinsons disease Gastric emptying time Mosapride Domperidone Prokinetic

Interventions

Mosapride 5 miligram and domperidone placebo oral three times a day for four weeks. ,Domperidone 10 miligram and mosapride placebo oral three times a day for four weeks.
Experimental Drug,Active Comparator Drug
Mosapride arm,Domperidone arm

Sponsors

Faculty of Medicine, Prince of Songkla University
Lead Sponsor
Gastroenterological Association of Thailand (GAT)
Collaborator

Eligibility

Sex/Gender
All
Age
20 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Gastric emptying half time 4 weeks Gastric scintigraphy

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactSawangpong Jandee

Faculty of Medicine, Prince of Songkla University

sawangpong.jan@hotmail.com074451479

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026