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

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ClinicalTrials.gov Identifier: NCT02025751
Recruitment Status : Completed
First Posted : January 1, 2014
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Evoke Pharma

Brief Summary:
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.

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

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 3 Companion Study of Intranasal Metoclopramide in Men With Symptomatic Diabetic Gastroparesis
Actual Study Start Date : April 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Metoclopramide Nasal Spray
Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks
Drug: Metoclopramide Nasal Spray
One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)

Placebo Comparator: Placebo Nasal Spray
Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks
Drug: Placebo Nasal Spray
One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)
Other Name: Vehicle




Primary Outcome Measures :
  1. Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure [ Time Frame: Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population) ]
    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.



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:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male 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
  • 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
  • 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

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): NCT02025751


Locations
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Sponsors and Collaborators
Evoke Pharma
Investigators
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Study Director: Marilyn R Carlson, DMD, MD Evoke Pharma, Inc.
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Responsible Party: Evoke Pharma
ClinicalTrials.gov Identifier: NCT02025751    
Other Study ID Numbers: METO-IN-004
First Posted: January 1, 2014    Key Record Dates
Results First Posted: July 7, 2020
Last Update Posted: July 7, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Evoke Pharma:
Diabetes
Gastroparesis
Delayed gastric emptying
Nausea
Vomiting
Bloating
Abdominal pain
Early Satiety
Gastric stasis
Gastropathy
Additional relevant MeSH terms:
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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