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GastroparesisPhase 2NCT00845858

Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis

A Phase 2 study testing metoclopramide in people with Gastroparesis and Diabetic Gastroparesis, run by Evoke Pharma at 65 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

To evaluate the safety and the effectiveness of two doses of metoclopramide nasal spray solution, 10 mg and 14 mg, compared to placebo in reducing the symptoms of diabetic gastroparesis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastroparesis, Diabetic Gastroparesis, Diabetes
What is being tested?
metoclopramide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
287 participants
Where
65 sitesUnited States
Study dates
Apr 2009to Dec 2011
Phase
Phase 2
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male subjects and non-pregnant, non-lactating female subjects between the ages of 18 and 75 years (inclusive)
  • Willing and able to give written informed consent to participate in the study
  • Ability to read and understand English
  • Diagnosis of Type 1 or Type 2 diabetes
  • Diagnosis of diabetic gastroparesis previously documented
  • A mean daily GCSI-DD score of ≥2 and ≤4 for the 7 days prior to the Randomization Visit (Visit 3, Day 0)
Show all 9Show fewer
  • Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from Screening through the last dose of study drug: hormonal (oral, implant, or injection) begun >30 days prior to screening, barrier (condom, diaphragm, or cervical cap with spermicide), intrauterine device (IUD), or vasectomized partner (6-months minimum)
  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results (with the exception of lipid profile, glucose and hemoglobin A1c) during screening which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
  • Willingness to discontinue current treatment for diabetic gastroparesis and to avoid all medications specified by the protocol for the duration of the study

Who cannot join

  • Gastric bypass and gastric banding, gastric pacemakers, post-surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility such as active gastric ulcer, active duodenal ulcer, active severe gastritis, gastric cancer, amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, alcoholism, uremia, malnutrition, and untreated hypothyroidism
  • 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
  • History of or physical findings suggestive of tardive dyskinesia
  • Currently using and unwilling or unable to stop any medication known to be associated with tardive dyskinesia (See Study Reference Manual) prior to Washout (Visit 2)
  • History of allergy to any of the ingredients in the study drug formulation; metoclopramide, citric acid, sodium citrate, benzalkonium chloride, EDTA, or sorbitol
  • History of organ transplant, chronic pancreatitis, gross malabsorptive syndromes, celiac disease, or inflammatory bowel disease
Show all 18Show fewer
  • Malignancy (with the exception of basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within 5 years of enrollment
  • History of other clinically significant renal, hepatic, neurologic, hematologic, oncologic, pulmonary, psychiatric, cardiovascular or infectious disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
  • Have renal dysfunction calculated as creatinine clearance (CrCl) < 40 mL/min at Screening (Visit 1)
  • Have a hemoglobin A1c > 12.5% at Screening (Visit 1)
  • Inability or unwillingness to stop using the following agents for 7 days during the Washout Period (Day -7 to Day -1) prior to Randomization (Visit 3, Day 0) and refrain from their use for the 4-week study period; oral and parenteral formulations of metoclopramide, domperidone, tricyclic antidepressants, macrolide antibiotics, prokinetic agents, cholinergic agents, agents with significant anticholinergic effects, narcotic analgesics, orally administered β agonists, spasmolytics, dopamine agonists, monoamine oxidase inhibitors, herbal supplements, fiber or bulking products, and laxatives
  • Use of neurotoxins (e.g., botulinum type A or B) as a treatment for gastroparesis or delayed gastric emptying within 6 months of Screening (Visit 1)
  • Clinically significant abnormal finding or a QTc interval >450 milliseconds (msec) on ECGs obtained at Screening (Visit 1) OR pre- or post-dose at Randomization (Visit 3)
  • Inability or unwillingness to stop using medications associated with Torsades de Pointes or a prolonged QT interval for 30 days prior to the initial symptom assessment and refrain from their use for the 4-week study period (see Study Reference Manual)
  • Female subjects who are trying to conceive, are pregnant, or are lactating
  • Positive serum human chorionic gonadotropin (HCG) pregnancy test at Screening or a positive HCG urine test on Day 0 prior to administration of study drug for women of childbearing potential
  • History of alcohol or drug abuse within the year prior to the Screening Visit, or current known evidence of substance dependence or abuse
  • Participation in a clinical (investigational) trial or receipt of a non-FDA approved therapy within 30 days prior to the Screening Visit (Visit 1) with the exception of domperidone

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

United States65 sites

  • AGA

    Akron, Ohio, 44302

  • Lovelace Scientific Resources, Inc.

    Albuquerque, New Mexico, 87108

  • Saint John's Research Institute

    Anderson, Indiana, 46016

  • Lovelace Scientific Resources

    Austin, Texas, 78759

  • Jacinto Medical Group

    Baytown (Houston), Texas, 77521

  • Robert M. Karns, MD, a Medical Corporation

    Beverly Hills, California, 90211

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Consultants for Clinical Research of South Florida

    Boynton Beach, Florida, 33426

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Gastroenterology Associates of Tidewater

    Chesapeake, Virginia, 23320

  • Metropolitan Gastroenterology Group

    Chevy Chase, Maryland, 20815

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45211

  • Hightop Medical Research Center

    Cincinnati, Ohio, 45224

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756

  • Newton Medical Center

    Conyers, Georgia, 30013

  • Digestive Specialists of the Southeast

    Dothan, Alabama, 36305

  • Cumberland Research Associates

    Fayetteville, North Carolina, 28304

  • Memphis Gastroenterology Group

    Germantown, Tennessee, 38138

  • LeBauer Research Associates

    Greensboro, North Carolina, 27406

  • Dynamed Clinical Research

    Houston, Texas, 77034

  • Clinical Research Associates

    Huntsville, Alabama, 35801

  • Medical Affiliated Research Center, Inc.

    Huntsville, Alabama, 35801

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • CRC of Jackson, LLC

    Jackson, Mississippi, 39202

  • Gastrointestional Associates

    Jackson, Mississippi, 39202

  • HCCA Clinical Research Solutions

    Jackson, Tennessee, 37805

  • Medical Specialty Clinic Research

    Jackson, Tennessee, 38301

  • Borland-Groover Clinic

    Jacksonville, Florida, 32256

  • Clopton Clinic

    Jonesboro, Arkansas, 72401

  • Kansas City Gastroenterology & Hepatology

    Kansas City, Missouri, 64131

  • Holston Medical Group, PC

    Kingsport, Tennessee, 37660

  • Regional Gastroenterology Associates of Lancaster, Ltd.

    Lancaster, Pennsylvania, 17604

  • Maryland Digestive Disease Research, LLC

    Laurel, Maryland, 20707

  • PMA Medical Specialists

    Limerick, Pennsylvania, 19468

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • Impact Clinical Trials

    Los Angeles, California, 90036

  • Gastrointestinal Specialists of Georgia

    Marietta, Georgia, 30060

  • Great Lakes Gastroenterology

    Mentor, Ohio, 44060

  • Center for Digestive and Liver Diseases, Inc.

    Mexico, Missouri, 65265

  • AppleMed Research, Inc.

    Miami, Florida, 33155

  • International Research Associates, LLC

    Miami, Florida, 33183

  • Wisconsin Center for Advanced Research

    Milwaukee, Wisconsin, 53215

  • Prime-Care Clinical Research

    Mission Viejo, California, 92691

  • Delta Research Partners, LLC

    Monroe, Louisiana, 71201

  • Medex Healthcare Research, Inc.

    New York, New York, 10004

  • Research Associates of New York

    New York, New York, 10075

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Digestive Health Associates of Texas, P.A.

    Plano, Texas, 75075

  • Plymouth Clinic

    Plymouth, Minnesota, 55446

  • Gastroenterology Associates

    Poughkeepsie, New York, 12601

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Rockford Gastroenterology Associates

    Rockford, Illinois, 61107

  • Theda Oaks Endoscopy Center

    San Antonio, Texas, 78258

  • Arkansas Gastroenterology

    Sherwood, Arkansas, 72120

  • Cotton-O'Neil Clinical Research Center

    Topeka, Kansas, 66606

  • Endoscopic Microsurgery Associates

    Towson, Maryland, 21204

  • Desert Sun Gastroenterology

    Tucson, Arizona, 85710

  • Digestive Health Specialists

    Tupelo, Mississippi, 38801

  • Trinity Health Care

    Tyler, Texas, 75702

  • Gastroenterology, Ltd.

    Virginia Beach, Virginia, 23454

  • Infosphere Clinical Research, Inc.

    West Hills, California, 91307

  • Westlake Medical Research

    Westlake Village, California, 91361

  • Professional Research Network of Kansas

    Wichita, Kansas, 67203

  • Hanover Medical Specialists

    Wilmington, North Carolina, 28401

  • Piedmont Medical Research

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Dose-Ranging Clinical Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Subjects With Gastroparesis

To evaluate the safety and the effectiveness of two doses of metoclopramide nasal spray solution, 10 mg and 14 mg, compared to placebo in reducing the symptoms of diabetic gastroparesis.

Being tested
metoclopramide, Placebo
Keywords
Gastroparesis, Diabetic Gastroparesis, Diabetes, Diabetes Mellitus, Delayed Gastric Emptying
Medical subject headings
Gastroparesis, Diabetes Mellitus

What participants receive

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

  • metoclopramideDrug

    Also called Reglan

    30 minutes before meals and at bedtime for 4 weeks

  • PlaceboDrug

    30 minutes before meals and at bedtime

Study groups in NCT00845858
Study groupRoleWhat they receive
Metoclopramide Nasal Spray 10 mgActive comparatorNot described
Receives: Drug: metoclopramide
Metoclopramide Nasal Spray 14 mgActive comparatorNot described
Receives: Drug: metoclopramide
Placebo Nasal SprayPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. The Primary Efficacy Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score.

    Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in male and female subjects receiving metoclopramide nasal spray versus subjects receiving placebo.

    The mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe).

    1. Nausea (feeling sick to your stomach as if you were going to vomit or throw up)
    2. Early satiety (not able to finish a normal sized meal)
    3. Bloating (feeling like you need to loosen clothes)
    4. Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period.

    A mean change (improvement) of >1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful.

    Measured: 4 weeks

Timeline

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

  1. First posted18 Feb 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
287 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00845858
Sponsor's protocol ID
METO-IN-002
Status last verified
Nov 2013
First submitted
17 Feb 2009
Last updated
27 Jun 2014
Data monitoring committee
No

Publications

  • Parkman HP, Carlson MR, Gonyer D. Metoclopramide Nasal Spray Reduces Symptoms of Gastroparesis in Women, but not Men, With Diabetes: Results of a Phase 2B Randomized Study. Clin Gastroenterol Hepatol. 2015 Jul;13(7):1256-1263.e1. doi: 10.1016/j.cgh.2014.12.030. Epub 2015 Jan 7.

    PubMed 25576687

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing metoclopramide in people with Gastroparesis and Diabetic Gastroparesis, run by Evoke Pharma at 65 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 9 inclusion and 18 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 17 Jun 2014). 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?

The Primary Efficacy Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score. (time frame: 4 weeks). 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 NCT00845858, which also lists 1 linked publication.

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 27 Jun 2014.

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