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

Primary Purpose

Diabetic Gastroparesis

Status

Unknown status

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Mosapride

domperidone

About this trial

This is an interventional treatment trial for Diabetic Gastroparesis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mosapride

domperidone

Arm Description

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

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

Outcomes

Primary Outcome Measures

The improvement of gastric emptying time after taking the medicine

Gastric emptying time will be tested by C13 breath test.

Secondary Outcome Measures

Full Information

NCT ID

NCT02264587

First Posted

August 27, 2014

Last Updated

October 14, 2014

Sponsor

Liangzhou Wei

Collaborators

Sumitomo Pharma (Suzhou) Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02264587

Brief Title

Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis

Acronym

MDGP

Official Title

Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

September 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Liangzhou Wei

Collaborators

Sumitomo Pharma (Suzhou) Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Gastroparesis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mosapride

Arm Type

Experimental

Arm Description

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

Arm Title

domperidone

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Mosapride

Other Intervention Name(s)

Gasmotin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

domperidone

Other Intervention Name(s)

Motilium

Intervention Description

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

Primary Outcome Measure Information:

Title

The improvement of gastric emptying time after taking the medicine

Description

Gastric emptying time will be tested by C13 breath test.

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

12. IPD Sharing Statement

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Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis

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