Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02264587

Acronym

MDGP

Enrollment

Registered

2014-10-15

Start date

2014-10-31

Completion date

2015-12-31

Last updated

2014-10-15

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

Conditions

Diabetic Gastroparesis

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 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.

Interventions

DRUGMosapride

Mosapride 5mg by mouth ,3 times one day for 1 4days.

DRUGdomperidone

Domperidone 10mg by mouth ,3 times one day for 1 4days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
The improvement of gastric emptying time after taking the medicine	2 weeks	Gastric emptying time will be tested by C13 breath test.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026