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Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02025725
Recruitment Status : Completed
First Posted : January 1, 2014
Last Update Posted : June 27, 2018
Information provided by (Responsible Party):
Evoke Pharma

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Gastroparesis Drug: Metoclopramide Nasal Spray Drug: Placebo Nasal Spray Phase 3

Detailed Description:
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.

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 : April 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

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
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
Drug: Placebo Nasal Spray
nasal spray formulation with vehicle only
Other Name: EVK-001 Placebo

Primary Outcome Measures :
  1. Patient Reported Outcome (PRO) Symptom Diary [ Time Frame: Change from baseline in symptom score at Week 4 ]
    Subjects will an interactive voice response system (IVRS) to record the severity of their gastroparesis symptoms on a daily basis until their last full day on study prior to their final visit

Secondary Outcome Measures :
  1. Population Pharmacokinetics [ Time Frame: Study Day 7 ]
    Pharmacokinetic parameters derived from the plasma concentrations of metoclopramide collected; maximum plasma concentration (Cmax), time to Cmax (Tmax), elimination half-life (t1/2), areas under the concentration-time curve (AUC) to the final sample AUC(0-t)

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02025725

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Sponsors and Collaborators
Evoke Pharma
Study Director: Marilyn R. Carlson, DMD, MD Evoke Pharma, Inc.

Responsible Party: Evoke Pharma Identifier: NCT02025725     History of Changes
Other Study ID Numbers: METO-IN-003
First Posted: January 1, 2014    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Evoke Pharma:
Delayed gastric emptying
Gastric stasis
Abdominal pain
Early satiety

Additional relevant MeSH terms:
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Signs and Symptoms
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