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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
Last Update Posted : June 14, 2017
Sponsor:
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
Primary Completion Date : May 2016
Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02025725


  Show 50 Study Locations
Sponsors and Collaborators
Evoke Pharma
Investigators
Study Director: Marilyn R. Carlson, DMD, MD Evoke Pharma, Inc.

Responsible Party: Evoke Pharma
ClinicalTrials.gov Identifier: NCT02025725     History of Changes
Other Study ID Numbers: METO-IN-003
First Posted: January 1, 2014    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Evoke Pharma:
Gastroparesis
Diabetic
Delayed gastric emptying
Gastric stasis
Nausea
Vomiting
Bloating
Abdominal pain
Early satiety
Gastropathy

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