Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis
- Conditions
- GastroparesisDiabetic GastroparesisDiabetesDiabetes MellitusDelayed Gastric Emptying
- Interventions
- Drug: Placebo
- Registration Number
- NCT00845858
- Lead Sponsor
- Evoke Pharma
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 287
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Nasal Spray Placebo - Metoclopramide Nasal Spray 10 mg metoclopramide - Metoclopramide Nasal Spray 14 mg metoclopramide -
- Primary Outcome Measures
Name Time Method 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. 4 weeks 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (65)
Impact Clinical Trials
🇺🇸Los Angeles, California, United States
Theda Oaks Endoscopy Center
🇺🇸San Antonio, Texas, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Robert M. Karns, MD, a Medical Corporation
🇺🇸Beverly Hills, California, United States
Innovative Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
AppleMed Research, Inc.
🇺🇸Miami, Florida, United States
Arkansas Gastroenterology
🇺🇸Sherwood, Arkansas, United States
Digestive Specialists of the Southeast
🇺🇸Dothan, Alabama, United States
Medical Affiliated Research Center, Inc.
🇺🇸Huntsville, Alabama, United States
Clopton Clinic
🇺🇸Jonesboro, Arkansas, United States
Dynamed Clinical Research
🇺🇸Houston, Texas, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Metropolitan Gastroenterology Group
🇺🇸Chevy Chase, Maryland, United States
Professional Research Network of Kansas
🇺🇸Wichita, Kansas, United States
Maryland Digestive Disease Research, LLC
🇺🇸Laurel, Maryland, United States
Gastrointestinal Specialists of Georgia
🇺🇸Marietta, Georgia, United States
Lovelace Scientific Resources
🇺🇸Austin, Texas, United States
PMA Medical Specialists
🇺🇸Limerick, Pennsylvania, United States
Hightop Medical Research Center
🇺🇸Cincinnati, Ohio, United States
Digestive and Liver Disease Specialists
🇺🇸Norfolk, Virginia, United States
Clinical Research Associates
🇺🇸Huntsville, Alabama, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
Consultants for Clinical Research of South Florida
🇺🇸Boynton Beach, Florida, United States
Prime-Care Clinical Research
🇺🇸Mission Viejo, California, United States
Infosphere Clinical Research, Inc.
🇺🇸West Hills, California, United States
VA Long Beach Healthcare System
🇺🇸Long Beach, California, United States
Rockford Gastroenterology Associates
🇺🇸Rockford, Illinois, United States
International Research Associates, LLC
🇺🇸Miami, Florida, United States
Newton Medical Center
🇺🇸Conyers, Georgia, United States
Saint John's Research Institute
🇺🇸Anderson, Indiana, United States
Cotton-O'Neil Clinical Research Center
🇺🇸Topeka, Kansas, United States
Delta Research Partners, LLC
🇺🇸Monroe, Louisiana, United States
Endoscopic Microsurgery Associates
🇺🇸Towson, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Plymouth Clinic
🇺🇸Plymouth, Minnesota, United States
Gastrointestional Associates
🇺🇸Jackson, Mississippi, United States
CRC of Jackson, LLC
🇺🇸Jackson, Mississippi, United States
Digestive Health Specialists
🇺🇸Tupelo, Mississippi, United States
Kansas City Gastroenterology & Hepatology
🇺🇸Kansas City, Missouri, United States
Center for Digestive and Liver Diseases, Inc.
🇺🇸Mexico, Missouri, United States
Medex Healthcare Research, Inc.
🇺🇸New York, New York, United States
Gastroenterology Associates
🇺🇸Poughkeepsie, New York, United States
Cumberland Research Associates
🇺🇸Fayetteville, North Carolina, United States
Piedmont Medical Research
🇺🇸Winston-Salem, North Carolina, United States
LeBauer Research Associates
🇺🇸Greensboro, North Carolina, United States
Research Associates of New York
🇺🇸New York, New York, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Hanover Medical Specialists
🇺🇸Wilmington, North Carolina, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
🇺🇸Lancaster, Pennsylvania, United States
Medical Specialty Clinic Research
🇺🇸Jackson, Tennessee, United States
Holston Medical Group, PC
🇺🇸Kingsport, Tennessee, United States
Digestive Health Associates of Texas, P.A.
🇺🇸Plano, Texas, United States
Jacinto Medical Group
🇺🇸Baytown (Houston), Texas, United States
Gastroenterology Associates of Tidewater
🇺🇸Chesapeake, Virginia, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Gastroenterology, Ltd.
🇺🇸Virginia Beach, Virginia, United States
Lovelace Scientific Resources, Inc.
🇺🇸Albuquerque, New Mexico, United States
AGA
🇺🇸Akron, Ohio, United States
Trinity Health Care
🇺🇸Tyler, Texas, United States
Desert Sun Gastroenterology
🇺🇸Tucson, Arizona, United States
HCCA Clinical Research Solutions
🇺🇸Jackson, Tennessee, United States
Westlake Medical Research
🇺🇸Westlake Village, California, United States
Memphis Gastroenterology Group
🇺🇸Germantown, Tennessee, United States
Borland-Groover Clinic
🇺🇸Jacksonville, Florida, United States
Great Lakes Gastroenterology
🇺🇸Mentor, Ohio, United States