Diabetic GastroparesisPhase 3NCT02025751

Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis

A Phase 3 study testing Metoclopramide Nasal Spray in people with Diabetic Gastroparesis, run by Evoke Pharma at 49 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is evaluate the safety and efficacy of Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult men. Read more about this study

Who is it for?: Ages 18 to 75 years, men only
Conditions the study is for: Diabetic Gastroparesis
What is being tested?: Metoclopramide Nasal Spray
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 53 participants
Where: 49 sitesUnited States
Study dates: Apr 2014to Oct 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Male subjects between the ages of 18 and 75 years
Willingness and ability to give written informed consent
The ability to read, understand and speak English
Prior diagnosis of Type 1 or Type 2 diabetes
Diagnosis of diabetic gastroparesis with confirmation of delayed gastric emptying
A mean daily gastroparesis symptom score of ≥1.4 and ≤3.5 prior to randomization
Willingness to discontinue current treatment for diabetic gastroparesis and to avoid all proscribed (excluded) medications, as specified by the protocol, for the duration of the study

Who cannot join

Gastric bypass, gastric banding, gastric pacemaker, post surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility
A history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia, to metoclopramide or any comparable or similar product
A history of, or physical findings suggestive of, tardive dyskinesia
A history of epilepsy or currently using and unwilling or unable stop other drugs known to be associated with extrapyramidal reactions at screening
Malignancy (with the exception of treated squamous cell or basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within five (5) years of screening
Renal dysfunction calculated as creatinine clearance (CrCl) <40 mL/min at screening
Hemoglobin A1c >11.5% at screening

Trial locations and contacts

49 sites in 1 country.

City, postcode or hospital

49 sites in 1 country

United States49 sites

Lovelace Scientific Resources, Inc.
Albuquerque, New Mexico, 87108
Texas Clinical Research Institute
Arlington, Texas, 76012
Tri-County Research
Athens, Georgia, 30606
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309
Lovelace Scientific Resources
Austin, Texas, 78758
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809
Dayton Gastroenterology
Beavercreek, Ohio, 45440
Birmingham Gasteroenterology Associates, P.C.
Birmingham, Alabama, 35209
Burke Internal Medicine
Burke, Virginia, 22015
Clinical Research Institute of Michigan
Chesterfield, Michigan, 48047
Precision Research Institute, LLC
Chula Vista, California, 91910
John Muir Physician Network Clinical Research Center
Concord, California, 94520
Newton Medical Center
Conyers, Georgia, 30013
Digestive Specialists of the Southeast
Dothan, Alabama, 36305
Texas Tech University Health Sciences Center
El Paso, Texas, 79905
Cumberland Research Associates
Fayetteville, North Carolina, 28304
LeBauer Research Associates
Greensboro, North Carolina, 27406
The Center for Gastrointestinal Disorders
Hollywood, Florida, 33021
Clinical Research Associates
Huntsville, Alabama, 35801
Indiana University Health UH 1634
Indianapolis, Indiana, 46202
Nature Coast Clinical Research
Inverness, Florida, 34452
HCCA Clinical Research Solutions
Jackson, Tennessee, 37805
Kansas City Gastroenterology & Hepatology
Kansas City, Missouri, 64131
Gastroenterology Associates
Kingsport, Tennessee, 37660
Kinston Medical Specialist Clinical Research Office
Kinston, North Carolina, 28501
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Preferred Research Partners
Little Rock, Arkansas, 72211
Manassas Clinical Research
Manassas, Virginia, 20110
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060
Atlanta Gastroenterology Associates
Marietta, Georgia, 30067
Central Arizone Medical Associates/Clinical Research Advantage
Mesa, Arizona, 85206
International Research Associates, LLC
Miami, Florida, 33183
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215
Delta Research Partners, LLC
Monroe, Louisiana, 71201
Quality Medical Research
Nashville, Tennessee, 37211
National Clinical Research
Norfolk, Virginia, 23502
Southwest Gastroenterology
Oak Lawn, Illinois, 60453
Temple University
Philadelphia, Pennsylvania, 19140
Advanced Medical Research
Port Orange, Florida, 32127
Premier Medical Group of the Hudson, PC
Poughkeepsie, New York, 12601
Wake Research Associates
Raleigh, North Carolina, 27612
PMG Research of Salisbury
Salisbury, North Carolina, 28144
Precision Research Institute, LLC
San Diego, California, 92114
Arkansas Gastroenterology
Sherwood, Arkansas, 72120
Center for Digestive Health
Troy, Michigan, 48098
The Gastroenterology Group of South Jersey
Vineland, New Jersey, 08360
Professional Research Network of Kansas
Wichita, Kansas, 67203
Piedmont Medical Research
Winston-Salem, North Carolina, 27103
Gastroenterology Associates of Western Michigan
Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: Phase 3 Companion Study of Intranasal Metoclopramide in Men With Symptomatic Diabetic Gastroparesis

The purpose of this study is evaluate the safety and efficacy of Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult men.

Read the detailed description

Diabetic men with clinical symptoms attributed to diabetic gastroparesis and documentation of delayed gastric emptying who meet the protocol-specified entry criteria will be randomized to Metoclopramide Nasal Spray 10 mg or placebo administered as a single intranasal spray four (4) times daily; 30 minutes before meals and at bedtime for a total of four (4) weeks.

Conditions: Diabetic Gastroparesis
Being tested: Metoclopramide Nasal Spray, Placebo Nasal Spray
Keywords: Diabetes, Gastroparesis, Delayed gastric emptying, Nausea, Vomiting, Bloating, Abdominal pain, Early Satiety, Gastric stasis, Gastropathy
Medical subject headings: Diabetes Mellitus, Gastroparesis, Nausea, Vomiting, Abdominal Pain, Stomach Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Metoclopramide Nasal SprayDrug
One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)
Placebo Nasal SprayDrug
Also called Vehicle
One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)

Study groups in NCT02025751
Study group	Role	What they receive
Metoclopramide Nasal Spray	Experimental	Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks Receives: Drug: Metoclopramide Nasal Spray
Placebo Nasal Spray	Placebo comparator	Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks Receives: Drug: Placebo Nasal Spray

What is being measured

The primary outcome is the main question the study is designed to answer.

Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure
Change from the Baseline Period to Week 4 of the Treatment Period in the mean daily Gastroparesis Symptom Assessment (GSA) total score for subjects receiving Metoclopramide Nasal Spray 10 mg versus subjects receiving placebo. The GSA minimum value is 0 (no symptoms) and the maximum value is 4 (very severe symptoms). A higher score is a worse outcome.
Measured: Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2014Oct 2016

First posted1 Jan 2014 (estimated)
Study startApr 2014
Primary completionAug 2016
Study completionOct 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02025751
Sponsor's protocol ID: METO-IN-004
Status last verified: Jun 2020
First submitted: 29 Dec 2013
Last updated: 7 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Diabetic Gastroparesis trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 3 Companion Study of Intranasal Metoclopramide in Men With Symptomatic Diabetic Gastroparesis
ClinicalTrials.gov ID: NCT02025751
Acronym / sponsor ID: METO-IN-004
Conditions: Diabetic Gastroparesis
Keywords: Diabetes, Gastroparesis, Delayed gastric emptying, Nausea, Vomiting, Bloating, Abdominal pain, Early Satiety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Evoke PharmaIndustry (pharma, biotech, devices)
Study start: Apr 2014 (actual)
Primary completion: Aug 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 1 Jan 2014 (estimated)
Results: Posted 7 Jul 2020

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 evaluate the safety and efficacy of Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult men.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Metoclopramide Nasal Spray	Experimental	Drug: Metoclopramide Nasal SprayMetoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
Placebo Nasal Spray	Placebo comparator	Drug: Placebo Nasal SprayPlacebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks

Who may qualify

Ages: 18 to 75 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Male subjects between the ages of 18 and 75 years
Willingness and ability to give written informed consent
The ability to read, understand and speak English
Prior diagnosis of Type 1 or Type 2 diabetes
Diagnosis of diabetic gastroparesis with confirmation of delayed gastric emptying

Key exclusion criteria (7 listed)

Gastric bypass, gastric banding, gastric pacemaker, post surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility
A history of allergic or adverse responses, including, but not limited to, acute dystonic reactions and tardive dyskinesia, to metoclopramide or any comparable or similar product
A history of, or physical findings suggestive of, tardive dyskinesia
A history of epilepsy or currently using and unwilling or unable stop other drugs known to be associated with extrapyramidal reactions at screening
Malignancy (with the exception of treated squamous cell or basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within five (5) years of screening

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
Metoclopramide Nasal SprayOne 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)	Drug	Metoclopramide Nasal Spray
Placebo Nasal SprayAlso: VehicleOne placebo spray dose 30 minutes before meals and before bed for 28 days (QID)	Drug	Placebo Nasal Spray

Primary outcome

Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure
Time frame: Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population)
Change from the Baseline Period to Week 4 of the Treatment Period in the mean daily Gastroparesis Symptom Assessment (GSA) total score for subjects receiving Metoclopramide Nasal Spray 10 mg versus subjects receiving placebo. The GSA minimum value is 0 (no symptoms) and the maximum value is 4 (very severe symptoms). A higher score is a worse outcome.

Results and safety

Results posted to the registry on 7 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Metoclopramide Nasal Spray	26	25
Placebo Nasal Spray	27	24

Primary outcome: Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure

Time frame: Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population). Mean (Standard Deviation). Unit: score on a scale

Measure	Metoclopramide Nasal Spray n = 26	Placebo Nasal Spray n = 27
Value	-0.751 (0.4673)	-0.657 (0.9042)

Metoclopramide Nasal Spray vs Placebo Nasal Spray: p = 0.597, ANCOVA

Adverse events

Time frame: 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Metoclopramide Nasal Spray	0 of 26 (0%)	7 of 26 (26.9%)	0 of 26
Placebo Nasal Spray	3 of 27 (11.1%)	3 of 27 (11.1%)	0 of 27

Limitations and caveats (from the sponsor): Study failed to meet recruitment goals (N=150) and was completed after 24 months (N=53). All study visits and assessments were completed. Limited pharmacokinetic (PK) samples so no calculated PK parameters.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

Marilyn R Carlson, DMD, MD study director

Evoke Pharma, Inc.

49 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metoclopramide Nasal Spray in people with Diabetic Gastroparesis, run by Evoke Pharma at 49 sites in United States.

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 7 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: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure (time frame: Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02025751.

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 7 Jul 2020.