Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis
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ClinicalTrials.gov Identifier: NCT02025725 |
Recruitment Status :
Completed
First Posted : January 1, 2014
Results First Posted : February 11, 2020
Last Update Posted : July 7, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Gastroparesis | Drug: Metoclopramide Nasal Spray Drug: Placebo Nasal Spray | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 205 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Phase 3 Study of Intranasal Metoclopramide in Women With Symptomatic Diabetic Gastroparesis |
Study Start Date : | March 27, 2014 |
Actual Primary Completion Date : | May 27, 2016 |
Actual Study Completion Date : | June 27, 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: 10 mg Metoclopramide Nasal Spray
Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
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Drug: Metoclopramide Nasal Spray
nasal spray formulation of metoclopramide
Other Name: EVK-001 |
Placebo Comparator: Placebo Nasal Spray
Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks
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Drug: Placebo Nasal Spray
nasal spray formulation with vehicle only
Other Name: EVK-001 Placebo |
- Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure [ Time Frame: Baseline Period to Week 4 of the Treatment Period ]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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Non pregnant, non lactating female 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
- Subjects of childbearing potential must agree to use contraception
- 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
- A history of allergy to any of the ingredients in the study drug formulation
- A history of organ transplant, chronic pancreatitis, gross malabsorptive syndromes, celiac disease, active inflammatory bowel disease (IBD), or symptomatic irritable bowel syndrome (IBS)
- 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
- Subjects who are trying to conceive, are pregnant, or are lactating

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025725

Study Director: | Marilyn R. Carlson, DMD, MD | Evoke Pharma, Inc. |
Responsible Party: | Evoke Pharma |
ClinicalTrials.gov Identifier: | NCT02025725 |
Other Study ID Numbers: |
METO-IN-003 |
First Posted: | January 1, 2014 Key Record Dates |
Results First Posted: | February 11, 2020 |
Last Update Posted: | July 7, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Gastroparesis Diabetic Delayed gastric emptying Gastric stasis Nausea |
Vomiting Bloating Abdominal pain Early satiety Gastropathy |
Gastroparesis Stomach Diseases Gastrointestinal Diseases Digestive System Diseases Paralysis Neurologic Manifestations Metoclopramide Antiemetics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Dopamine D2 Receptor Antagonists Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |