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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoclopramide Nasal Spray | Experimental | Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks |
|
| Placebo Nasal Spray | Placebo Comparator | Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metoclopramide Nasal Spray | Drug | One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marilyn R Carlson, DMD, MD | Evoke Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham Gasteroenterology Associates, P.C. | Birmingham | Alabama | 35209 | United States | ||
| Digestive Specialists of the Southeast |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metoclopramide Nasal Spray | Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks Metoclopramide Nasal Spray: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID) |
| FG001 | Placebo Nasal Spray |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo Nasal Spray | Drug | One placebo spray dose 30 minutes before meals and before bed for 28 days (QID) |
|
|
| Dothan |
| Alabama |
| 36305 |
| United States |
| Clinical Research Associates | Huntsville | Alabama | 35801 | United States |
| Central Arizone Medical Associates/Clinical Research Advantage | Mesa | Arizona | 85206 | United States |
| Preferred Research Partners | Little Rock | Arkansas | 72211 | United States |
| Arkansas Gastroenterology | Sherwood | Arkansas | 72120 | United States |
| Precision Research Institute, LLC | Chula Vista | California | 91910 | United States |
| John Muir Physician Network Clinical Research Center | Concord | California | 94520 | United States |
| Precision Research Institute, LLC | San Diego | California | 92114 | United States |
| The Center for Gastrointestinal Disorders | Hollywood | Florida | 33021 | United States |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | United States |
| International Research Associates, LLC | Miami | Florida | 33183 | United States |
| Advanced Medical Research | Port Orange | Florida | 32127 | United States |
| Tri-County Research | Athens | Georgia | 30606 | United States |
| Digestive Healthcare of Georgia | Atlanta | Georgia | 30309 | United States |
| Newton Medical Center | Conyers | Georgia | 30013 | United States |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | United States |
| Atlanta Gastroenterology Associates | Marietta | Georgia | 30067 | United States |
| Southwest Gastroenterology | Oak Lawn | Illinois | 60453 | United States |
| Indiana University Health UH 1634 | Indianapolis | Indiana | 46202 | United States |
| Professional Research Network of Kansas | Wichita | Kansas | 67203 | United States |
| Gastroenterology Associates, LLC | Baton Rouge | Louisiana | 70809 | United States |
| Delta Research Partners, LLC | Monroe | Louisiana | 71201 | United States |
| Clinical Research Institute of Michigan | Chesterfield | Michigan | 48047 | United States |
| Center for Digestive Health | Troy | Michigan | 48098 | United States |
| Gastroenterology Associates of Western Michigan | Wyoming | Michigan | 49519 | United States |
| Kansas City Gastroenterology & Hepatology | Kansas City | Missouri | 64131 | United States |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| The Gastroenterology Group of South Jersey | Vineland | New Jersey | 08360 | United States |
| Lovelace Scientific Resources, Inc. | Albuquerque | New Mexico | 87108 | United States |
| Premier Medical Group of the Hudson, PC | Poughkeepsie | New York | 12601 | United States |
| Cumberland Research Associates | Fayetteville | North Carolina | 28304 | United States |
| LeBauer Research Associates | Greensboro | North Carolina | 27406 | United States |
| Kinston Medical Specialist Clinical Research Office | Kinston | North Carolina | 28501 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| PMG Research of Salisbury | Salisbury | North Carolina | 28144 | United States |
| Piedmont Medical Research | Winston-Salem | North Carolina | 27103 | United States |
| Dayton Gastroenterology | Beavercreek | Ohio | 45440 | United States |
| Temple University | Philadelphia | Pennsylvania | 19140 | United States |
| HCCA Clinical Research Solutions | Jackson | Tennessee | 37805 | United States |
| Gastroenterology Associates | Kingsport | Tennessee | 37660 | United States |
| Quality Medical Research | Nashville | Tennessee | 37211 | United States |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | United States |
| Lovelace Scientific Resources | Austin | Texas | 78758 | United States |
| Texas Tech University Health Sciences Center | El Paso | Texas | 79905 | United States |
| Burke Internal Medicine | Burke | Virginia | 22015 | United States |
| Manassas Clinical Research | Manassas | Virginia | 20110 | United States |
| National Clinical Research | Norfolk | Virginia | 23502 | United States |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53215 | United States |
Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks Placebo Nasal Spray: One placebo spray dose 30 minutes before meals and before bed for 28 days (QID) |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metoclopramide Nasal Spray | Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks Metoclopramide Nasal Spray: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID) |
| BG001 | Placebo Nasal Spray | Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks Placebo Nasal Spray: One placebo spray dose 30 minutes before meals and before bed for 28 days (QID) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Gastroparesis Symptom Assessment | Daily symptom diary collected using IVR | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population) |
|
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|
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metoclopramide Nasal Spray | Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks Metoclopramide Nasal Spray: One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID) | 0 | 26 | 0 | 26 | 7 | 26 |
| EG001 | Placebo Nasal Spray | Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks Placebo Nasal Spray: One placebo spray dose 30 minutes before meals and before bed for 28 days (QID) | 0 | 27 | 3 | 27 | 3 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment | Worsening of gastroparesis |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment | Uncontrolled diabetes mellitus |
|
| Staphylococcal infection | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment | Abscess left shin (MRSA) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Liver palpable | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (19.0) | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Oesophagitis ulcerative | Gastrointestinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (19.0) | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (19.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (19.0) | Non-systematic Assessment |
|
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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Evoke Pharma | 8589457189 | mcarlson@evokepharma.com |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D018589 | Gastroparesis |
| D009325 | Nausea |
| D014839 | Vomiting |
| D015746 | Abdominal Pain |
| D013272 | Stomach Diseases |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D010146 | Pain |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|