Diabetic GastroparesisPhase 4MDGPNCT02264587
Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis
A Phase 4 study testing Mosapride and domperidone in people with Diabetic Gastroparesis, run by Liangzhou Wei.
Trial summary
The purpose of this study is to evaluate the effects and mechanism of mosapride citrate on diabetic gastroparesi. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Gastroparesis
- What is being tested?
- Mosapride and domperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
The purpose of this study is to evaluate the effects and mechanism of mosapride citrate on diabetic gastroparesi.
Read the 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.
- Conditions
- Diabetic Gastroparesis
- Being tested
- Mosapride, domperidone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MosaprideDrug
Also called Gasmotin
Mosapride 5mg by mouth ,3 times one day for 1 4days.
domperidoneDrug
Also called Motilium
Domperidone 10mg by mouth ,3 times one day for 1 4days.
| Study group | Role | What they receive |
|---|---|---|
| mosapride | Experimental | mosapride 5mg by mouth, 30 minutes before meals, every times one day for 14days Receives: Drug: Mosapride |
| domperidone | Active comparator | domperidone 10mg by mouth, 30 minutes before meals, every times one day for 14days Receives: Drug: domperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement of gastric emptying time after taking the medicine
Gastric emptying time will be tested by C13 breath test.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic GastroparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liangzhou Wei
- Sponsor type
- University, hospital or other
- Collaborators
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.
- Responsible party
- Sponsor-investigator, Liangzhou Wei, Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02264587
- Sponsor's protocol ID
- GAS-IIS-2013-03
- Acronym
- MDGP
- Status last verified
- Oct 2014
- First submitted
- 27 Aug 2014
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanism of Mosapride Citrate on Diabetic Gastroparesis
- ClinicalTrials.gov ID
- NCT02264587
- Acronym / sponsor ID
- MDGP / GAS-IIS-2013-03
- Conditions
- Diabetic Gastroparesis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Liangzhou WeiUniversity, hospital or other
- Collaborators
- Marubeni Pharmaceuticals (Suzhou) Co., Ltd.
- Study start
- Oct 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 15 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mosapride | Experimental | Drug: Mosapridemosapride 5mg by mouth, 30 minutes before meals, every times one day for 14days |
| domperidone | Active comparator | Drug: domperidonedomperidone 10mg by mouth, 30 minutes before meals, every times one day for 14days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MosaprideAlso: GasmotinMosapride 5mg by mouth ,3 times one day for 1 4days. | Drug | mosapride |
| domperidoneAlso: MotiliumDomperidone 10mg by mouth ,3 times one day for 1 4days. | Drug | domperidone |
Primary outcome
The improvement of gastric emptying time after taking the medicine
Time frame: 2 weeks
Gastric emptying time will be tested by C13 breath test.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
Related trials for Diabetic Gastroparesis
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
Active, not recruiting
Impact of Per Oral Pyloromyotomy (POP) on Glycemic Control in Diabetes
Diabetes Mellitus, Gastroparesis With Diabetes Mellitus
Recruiting
Washed Microbiota Transplantation for Diabetic Gastroparesis
Diabetic Gastroparesis
Recruiting
Continuous Glucose Metrics in Patients With Gastroparesis in Type 1 or Type 2 Diabetes
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mosapride and domperidone in people with Diabetic Gastroparesis, run by Liangzhou Wei.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of gastric emptying time after taking the medicine (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2014.