Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis (MDGP)

Liangzhou Wei

Status and phase: Unknown; Phase 4

Conditions: Diabetic Gastroparesis

Treatments: Drug: Mosapride; Drug: domperidone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02264587

GAS-IIS-2013-03

Details and patient eligibility

About

The purpose of this study is to evaluate the effects and mechanism of mosapride citrate on diabetic gastroparesi.

Full 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 eating food containing C13, and then collect their expired gas at 15, 30,45,60,75,90,105,120,150,180,210,240min, analyse the mass of C13 by mass spectrometer, then can calculate the gastric emptying rate.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18≤ age ≤ 75
2. 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）
3. fasting blood-glucose≤7.0mmol/L and 2h postprandial plasma glucose≤10.0mmol/L
4. Be diagnosed diabetes more than 5 years, blood sugar steady in one month.
5. have the following symptoms for over 4weeks: early satiety ,postprandial fullness ,nausea, vomting,abdominal distension,belching, inappetence, epigastric pain, constipation.
6. Be diagnosed as Delayed Gastric Emptying by C13 breath test.
7. Signed informed consent.

Exclusion criteria

1. take gastrointestinal drugs within 2 weeks prior to screening. Or patients with other digestive disease.
2. 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 .
3. Serious ketoacidosis.
4. History of abdominal operation.
5. Thyroid hypofunction or hyperthyroidism.
6. nervous system disease or autoimmune diseases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

mosapride

Experimental group

Description:

mosapride 5mg by mouth, 30 minutes before meals, every times one day for 14days

Treatment:

Drug: Mosapride

domperidone

Active Comparator group

Description:

domperidone 10mg by mouth, 30 minutes before meals, every times one day for 14days

Treatment:

Drug: domperidone