We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02025751
First Posted: January 1, 2014
Last Update Posted: June 14, 2017
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.
Information provided by (Responsible Party):
Evoke Pharma
  Purpose
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 Intervention Phase
Diabetic Gastroparesis Drug: Metoclopramide Nasal Spray Drug: Placebo Nasal Spray Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Evoke Pharma:

Primary Outcome Measures:
  • 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:
  • 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)


Enrollment: 53
Actual Study Start Date: April 2014
Study Completion Date: October 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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
One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)
Other Name: Vehicle

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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
  Contacts and Locations
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


  Show 49 Study Locations
Sponsors and Collaborators
Evoke Pharma
Investigators
Study Director: Marilyn R Carlson, DMD, MD Evoke Pharma, Inc.
  More Information

Responsible Party: Evoke Pharma
ClinicalTrials.gov Identifier: NCT02025751     History of Changes
Other Study ID Numbers: METO-IN-004
First Submitted: December 29, 2013
First Posted: January 1, 2014
Last Update Posted: June 14, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Evoke Pharma:
Diabetes
Gastroparesis
Delayed gastric emptying
Nausea
Vomiting
Bloating
Abdominal pain
Early Satiety
Gastric stasis
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