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The purpose of this study is provide confirmation of the safety and efficacy of Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult women.
Diabetic women 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 |
|---|---|---|---|
| 10 mg 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 | nasal spray formulation of metoclopramide |
|
| 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. | Baseline Period to Week 4 of the Treatment Period |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37924856 | Derived | McCallum RW, Parkman HP, Fass R, Bhandari BR, Carlson MR, Buck RD. Metoclopramide Nasal Spray in Women With Symptomatic Diabetic Gastroparesis: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study. Clin Gastroenterol Hepatol. 2024 Dec;22(12):2497-2505.e5. doi: 10.1016/j.cgh.2023.10.022. Epub 2023 Nov 2. |
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613 participants Screened, 205 participants completed and randomized to treatment.
Negative Gastric Emptying Scintigraphy 129 Inclusion/Exclusion Failed 213 Withdrawal by participant 25 Other Reasons 41
Recruitment Period: 27 March 2014 to 27 May 2016
Types of Location: Medical Clinics, University-Based Practices
Screening Period consisted of Washout Period, Qualification Period and Baseline Period. Mean daily Gastroparesis Symptom Assessment (GSA) total score ≥ 1.4 and ≤ 3.5 was required during Qualification and Baseline periods
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| ID | Title | Description |
|---|---|---|
| FG000 | 10 mg Metoclopramide Nasal Spray | Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks Metoclopramide Nasal Spray: nasal spray formulation of metoclopramide |
| FG001 | Placebo Nasal Spray |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo Nasal Spray | Drug | nasal spray formulation with vehicle only |
|
|
| 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 |
| Gastrointestional Associates | Jackson | Mississippi | 39202 | 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: nasal spray formulation with vehicle only
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 10 mg Metoclopramide Nasal Spray | Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks Metoclopramide Nasal Spray: nasal spray formulation of metoclopramide |
| BG001 | Placebo Nasal Spray | Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks Placebo Nasal Spray: nasal spray formulation with vehicle only |
| 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 |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Only females were enrolled in this study | Count of Participants | Participants |
| |||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Race categories may add to > 100% since a subject's eCRF could indicate multiple races. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Qualification Mean Daily GSA Score | Mean | Standard Deviation | units on a scale |
| |||||||||||||||||
| Baseline Mean Daily GSA Score | Mean | Standard Deviation | units on a scale |
| |||||||||||||||||
| Diabetes Mellitus Type | Count of Participants | Participants |
| ||||||||||||||||||
| Diabetes Mellitus Duration | Mean | Standard Deviation | years |
| |||||||||||||||||
| Current Diabetes Mellitus Treatment | Count of Participants | Participants |
| ||||||||||||||||||
| Co-Existing Complications of Diabetes | Count of Participants | Participants |
|
| 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. | Intent-to-Treat (ITT) Population | Posted | Mean | Standard Deviation | score on a scale | Baseline Period to Week 4 of the Treatment Period |
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| Post-Hoc | Gastroparesis Symptom Assessment (GSA) | Change from the Baseline Period to Weeks 1, 2, 3 and 4 of the Treatment Period in the mean daily Gastroparesis Symptom Assessment (GSA) total score in subjects with moderate to severe symptoms at Baseline (GSA score greater than 2.7) 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. | Subjects in the intent-to-treat population with moderate to severe disease (symptoms) at Baseline (i.e., baseline GSA scores higher than 2.7 on the 0-4 scale). Results presented are Weeks 1, 2, 3 and 4 compared to the Baseline Period. | Posted | Mean | Standard Deviation | score on a scale | Baseline Period to Weeks 1, 2, 3 and 4 of the Treatment Period |
|
Adverse Event (AE) data were collected through the last study visit (Day 28). Serious AEs (SAEs) were collected for up to 30 days after the final dose of study drug.
Adverse event (AE) collection began after subjects signed the Informed Consent Form and continued until the subject was discharged from the study due to completion or Early Termination. All AEs observed by the Investigator, reported by the subject, from laboratory findings, or other means, were collected. AEs after the first dose of study drug were classified as treatment-emergent AEs.
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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 | 10 mg Metoclopramide Nasal Spray | Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime for 4 weeks Metoclopramide Nasal Spray: nasal spray formulation of metoclopramide | 0 | 102 | 3 | 102 | 21 | 102 |
| EG001 | Placebo Nasal Spray | Placebo Nasal Spray 30 minutes before meals and at bedtime for 4 weeks Placebo Nasal Spray: nasal spray formulation with vehicle only | 0 | 103 | 2 | 103 | 36 | 103 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| orthostatic hypotension | Vascular disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| cellulitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| chalazion | Eye disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| anxiety disorder | Psychiatric disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| non-cardiac chest pain | General disorders | MedDRA 19.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Abdominal tenderness | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 19.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 19.0 | Non-systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 19.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Evoke | 858-345-1494 | 206 | mcarlson@evokepharma.com |
| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D009325 | Nausea |
| D014839 | Vomiting |
| D015746 | Abdominal Pain |
| D013272 | Stomach Diseases |
| ID | Term |
|---|---|
| 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 |
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| Male |
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| 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 |
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| More than one race |
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| Unknown or Not Reported |
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| Type 2 |
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| Oral Diabetic Medications |
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| Insulin |
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| Other |
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| None |
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| Any Complication |
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| Diabetic Retinopathy |
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| Neuropathy |
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| Nephropathy |
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| Peripheral Vascular Disease/Amputation |
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| Participants |
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