Status:
UNKNOWN
Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis
Lead Sponsor:
Liangzhou Wei
Collaborating Sponsors:
Sumitomo Pharma (Suzhou) Co., Ltd.
Conditions:
Diabetic Gastroparesis
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the effects and mechanism of mosapride citrate on diabetic gastroparesi.
Detailed Description
To evaluate the effect of mosapride on DPG by 13 C - octylic acid breath test. IF C13- octylic acid be absorbed by mucous membrane of small intestine, octylic acid will be oxidated to CO2.Patients ea...
Eligibility Criteria
Inclusion
- 18≤ 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT02264587
Start Date
October 1 2014
End Date
December 1 2015
Last Update
October 15 2014
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