Back to resultsMulticenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis
Primary Purpose
Diabetic Gastroparesis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Metoclopramide Nasal Spray
Placebo Nasal Spray
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Gastroparesis focused on measuring Diabetes, Gastroparesis, Delayed gastric emptying, Nausea, Vomiting, Bloating, Abdominal pain, Early Satiety, Gastric stasis, Gastropathy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Birmingham Gasteroenterology Associates, P.C.
- Digestive Specialists of the Southeast
- Clinical Research Associates
- Central Arizone Medical Associates/Clinical Research Advantage
- Preferred Research Partners
- Arkansas Gastroenterology
- Precision Research Institute, LLC
- John Muir Physician Network Clinical Research Center
- Precision Research Institute, LLC
- The Center for Gastrointestinal Disorders
- Nature Coast Clinical Research
- International Research Associates, LLC
- Advanced Medical Research
- Tri-County Research
- Digestive Healthcare of Georgia
- Newton Medical Center
- Gastrointestinal Specialists of Georgia, PC
- Atlanta Gastroenterology Associates
- Southwest Gastroenterology
- Indiana University Health UH 1634
- Professional Research Network of Kansas
- Gastroenterology Associates, LLC
- Delta Research Partners, LLC
- Clinical Research Institute of Michigan
- Center for Digestive Health
- Gastroenterology Associates of Western Michigan
- Kansas City Gastroenterology & Hepatology
- Dartmouth-Hitchcock Medical Center
- The Gastroenterology Group of South Jersey
- Lovelace Scientific Resources, Inc.
- Premier Medical Group of the Hudson, PC
- Cumberland Research Associates
- LeBauer Research Associates
- Kinston Medical Specialist Clinical Research Office
- Wake Research Associates
- PMG Research of Salisbury
- Piedmont Medical Research
- Dayton Gastroenterology
- Temple University
- HCCA Clinical Research Solutions
- Gastroenterology Associates
- Quality Medical Research
- Texas Clinical Research Institute
- Lovelace Scientific Resources
- Texas Tech University Health Sciences Center
- Burke Internal Medicine
- Manassas Clinical Research
- National Clinical Research
- Wisconsin Center for Advanced Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Metoclopramide Nasal Spray
Placebo Nasal Spray
Arm Description
Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02025751
Brief Title
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis
Official Title
Phase 3 Companion Study of Intranasal Metoclopramide in Men With Symptomatic Diabetic Gastroparesis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Evoke Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Gastroparesis
Keywords
Diabetes, Gastroparesis, Delayed gastric emptying, Nausea, Vomiting, Bloating, Abdominal pain, Early Satiety, Gastric stasis, Gastropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metoclopramide Nasal Spray
Arm Type
Experimental
Arm Description
Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
Arm Title
Placebo Nasal Spray
Arm Type
Placebo Comparator
Arm Description
Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Metoclopramide Nasal Spray
Intervention Description
One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)
Intervention Type
Drug
Intervention Name(s)
Placebo Nasal Spray
Other Intervention Name(s)
Vehicle
Intervention Description
One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)
Primary Outcome Measure Information:
Title
Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure
Description
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.
Time Frame
Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marilyn R Carlson, DMD, MD
Organizational Affiliation
Evoke Pharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Gasteroenterology Associates, P.C.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Digestive Specialists of the Southeast
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Clinical Research Associates
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Central Arizone Medical Associates/Clinical Research Advantage
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Preferred Research Partners
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
Arkansas Gastroenterology
City
Sherwood
State/Province
Arkansas
ZIP/Postal Code
72120
Country
United States
Facility Name
Precision Research Institute, LLC
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
John Muir Physician Network Clinical Research Center
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Precision Research Institute, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92114
Country
United States
Facility Name
The Center for Gastrointestinal Disorders
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Nature Coast Clinical Research
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
International Research Associates, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33183
Country
United States
Facility Name
Advanced Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Tri-County Research
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States
Facility Name
Digestive Healthcare of Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Newton Medical Center
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30013
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30067
Country
United States
Facility Name
Southwest Gastroenterology
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Indiana University Health UH 1634
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Professional Research Network of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Gastroenterology Associates, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Delta Research Partners, LLC
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Clinical Research Institute of Michigan
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Center for Digestive Health
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Gastroenterology Associates of Western Michigan
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Kansas City Gastroenterology & Hepatology
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
The Gastroenterology Group of South Jersey
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
Facility Name
Lovelace Scientific Resources, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Premier Medical Group of the Hudson, PC
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Cumberland Research Associates
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
LeBauer Research Associates
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27406
Country
United States
Facility Name
Kinston Medical Specialist Clinical Research Office
City
Kinston
State/Province
North Carolina
ZIP/Postal Code
28501
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
PMG Research of Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Piedmont Medical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Dayton Gastroenterology
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
HCCA Clinical Research Solutions
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
37805
Country
United States
Facility Name
Gastroenterology Associates
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Quality Medical Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Texas Clinical Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Lovelace Scientific Resources
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Burke Internal Medicine
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
Manassas Clinical Research
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
National Clinical Research
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis
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