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

NCT02025751 | Completed Phase 3 Results

• 1 other identifier: METO-IN-004
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 49

Brief 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.

Conditions

Diabetic Gastroparesis

Keywords

Diabetes; Gastroparesis; Delayed gastric emptying; Nausea; Vomiting; Bloating; Abdominal pain; Early Satiety; Gastric stasis; Gastropathy

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population)

Study Arms (2)

Metoclopramide Nasal Spray

EXPERIMENTAL

Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks

Drug: Metoclopramide Nasal Spray

Placebo Nasal Spray

PLACEBO COMPARATOR

Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks

Drug: Placebo Nasal Spray

Interventions

Metoclopramide Nasal Spray DRUG

One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)

Metoclopramide Nasal Spray

Placebo Nasal Spray DRUG

One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)

Also known as: Vehicle

Placebo Nasal Spray

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Evoke Pharma: lead

Study Sites (49)

Birmingham Gasteroenterology Associates, P.C.

Birmingham, Alabama, 35209, United States

Location

Digestive Specialists of the Southeast

Dothan, Alabama, 36305, United States

Location

Clinical Research Associates

Huntsville, Alabama, 35801, United States

Location

Central Arizone Medical Associates/Clinical Research Advantage

Mesa, Arizona, 85206, United States

Location

Preferred Research Partners

Little Rock, Arkansas, 72211, United States

Location

Arkansas Gastroenterology

Sherwood, Arkansas, 72120, United States

Location

Precision Research Institute, LLC

Chula Vista, California, 91910, United States

Location

John Muir Physician Network Clinical Research Center

Concord, California, 94520, United States

Location

Precision Research Institute, LLC

San Diego, California, 92114, United States

Location

The Center for Gastrointestinal Disorders

Hollywood, Florida, 33021, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

International Research Associates, LLC

Miami, Florida, 33183, United States

Location

Advanced Medical Research

Port Orange, Florida, 32127, United States

Location

Tri-County Research

Athens, Georgia, 30606, United States

Location

Digestive Healthcare of Georgia

Atlanta, Georgia, 30309, United States

Location

Newton Medical Center

Conyers, Georgia, 30013, United States

Location

Gastrointestinal Specialists of Georgia, PC

Marietta, Georgia, 30060, United States

Location

Atlanta Gastroenterology Associates

Marietta, Georgia, 30067, United States

Location

Southwest Gastroenterology

Oak Lawn, Illinois, 60453, United States

Location

Indiana University Health UH 1634

Indianapolis, Indiana, 46202, United States

Location

Professional Research Network of Kansas

Wichita, Kansas, 67203, United States

Location

Gastroenterology Associates, LLC

Baton Rouge, Louisiana, 70809, United States

Location

Delta Research Partners, LLC

Monroe, Louisiana, 71201, United States

Location

Clinical Research Institute of Michigan

Chesterfield, Michigan, 48047, United States

Location

Center for Digestive Health

Troy, Michigan, 48098, United States

Location

Gastroenterology Associates of Western Michigan

Wyoming, Michigan, 49519, United States

Location

Kansas City Gastroenterology & Hepatology

Kansas City, Missouri, 64131, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

The Gastroenterology Group of South Jersey

Vineland, New Jersey, 08360, United States

Location

Lovelace Scientific Resources, Inc.

Albuquerque, New Mexico, 87108, United States

Location

Premier Medical Group of the Hudson, PC

Poughkeepsie, New York, 12601, United States

Location

Cumberland Research Associates

Fayetteville, North Carolina, 28304, United States

Location

LeBauer Research Associates

Greensboro, North Carolina, 27406, United States

Location

Kinston Medical Specialist Clinical Research Office

Kinston, North Carolina, 28501, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

PMG Research of Salisbury

Salisbury, North Carolina, 28144, United States

Location

Piedmont Medical Research

Winston-Salem, North Carolina, 27103, United States

Location

Dayton Gastroenterology

Beavercreek, Ohio, 45440, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

HCCA Clinical Research Solutions

Jackson, Tennessee, 37805, United States

Location

Gastroenterology Associates

Kingsport, Tennessee, 37660, United States

Location

Quality Medical Research

Nashville, Tennessee, 37211, United States

Location

Texas Clinical Research Institute

Arlington, Texas, 76012, United States

Location

Lovelace Scientific Resources

Austin, Texas, 78758, United States

Location

Texas Tech University Health Sciences Center

El Paso, Texas, 79905, United States

Location

Burke Internal Medicine

Burke, Virginia, 22015, United States

Location

Manassas Clinical Research

Manassas, Virginia, 20110, United States

Location

National Clinical Research

Norfolk, Virginia, 23502, United States

Location

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Gastroparesis; Nausea; Vomiting; Abdominal Pain; Stomach Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Pain

Limitations and Caveats

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.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Evoke Pharma

mcarlson@evokepharma.com

8589457189

Study Officials

• Marilyn R Carlson, DMD, MD

  Evoke Pharma, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2013
• First Posted: January 1, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: July 7, 2020
• Results First Posted: July 7, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (49)