Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis

Diabetic Gastroparesis Clinical Trial

— MDGP  

Official title:

Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02264587
• Other study ID #: GAS-IIS-2013-03
• Status: Not yet recruiting
• Phase: Phase 4
• First received: August 27, 2014
• Last updated: October 14, 2014
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: October 2014
• Source: Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Gastroparesis
• Gastroparesis

Intervention

Drug:
• Mosapride
Mosapride 5mg by mouth ,3 times one day for 1 4days.
• domperidone
Domperidone 10mg by mouth ,3 times one day for 1 4days.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Liangzhou Wei	Sumitomo Pharmaceutical (Suzhou) Co., Ltd.

Outcome

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