Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis
MDGP
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the effects and mechanism of mosapride citrate on diabetic gastroparesi.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedFirst Posted
Study publicly available on registry
October 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedOctober 15, 2014
October 1, 2014
11 months
August 27, 2014
October 14, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
The improvement of gastric emptying time after taking the medicine
Gastric emptying time will be tested by C13 breath test.
2 weeks
Study Arms (2)
mosapride
EXPERIMENTALmosapride 5mg by mouth, 30 minutes before meals, every times one day for 14days
domperidone
ACTIVE COMPARATORdomperidone 10mg by mouth, 30 minutes before meals, every times one day for 14days
Interventions
Domperidone 10mg by mouth ,3 times one day for 1 4days.
Eligibility Criteria
You may qualify if:
- ≤ age ≤ 75
- Patients coincided to, the WHO diagnostic criteria for diabetes in 1999 (namely have diabetes symptoms, plasma glucose tendency for 11.1 / L, at any time or fasting plasma glucose tendency for 7.0 / L, or oral glucose tolerance test 2 h plasma glucose levels tendency for 11.1 / L）
- fasting blood-glucose≤7.0mmol/L and 2h postprandial plasma glucose≤10.0mmol/L
- Be diagnosed diabetes more than 5 years, blood sugar steady in one month.
- have the following symptoms for over 4weeks: early satiety ,postprandial fullness ,nausea, vomting,abdominal distension,belching, inappetence, epigastric pain, constipation.
- Be diagnosed as Delayed Gastric Emptying by C13 breath test.
- Signed informed consent.
You may not qualify if:
- take gastrointestinal drugs within 2 weeks prior to screening. Or patients with other digestive disease.
- All patients will be administrated gastroscope in order to exclude stomach or duodenum disease, pyloric obstruction. It's normal in Liver, gallbladder, pancreas,spleen, nephridium by Ultrasound examination .
- Serious ketoacidosis.
- History of abdominal operation.
- Thyroid hypofunction or hyperthyroidism.
- nervous system disease or autoimmune diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Liangzhou Weilead
- Sumitomo Pharma (Suzhou) Co., Ltd.collaborator
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Head of departments
Study Record Dates
First Submitted
August 27, 2014
First Posted
October 15, 2014
Study Start
October 1, 2014
Primary Completion
September 1, 2015
Study Completion
December 1, 2015
Last Updated
October 15, 2014
Record last verified: 2014-10