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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Evoke Pharma
Sponsor:
Information provided by (Responsible Party):
Evoke Pharma
ClinicalTrials.gov Identifier:
NCT02025751
First received: December 29, 2013
Last updated: July 11, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 150
Study Start Date: April 2014
Estimated Primary Completion Date: July 2015 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders 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
  • No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results which, in the opinion of the Investigator, would interfere with intranasal dosing, jeopardize the safety of the subject or impact the validity of the study results
  • 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; metoclopramide, citric acid, sodium citrate, benzalkonium chloride, ethylenediaminetetraacetic acid (EDTA), or sorbitol
  • 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
  • A history of other clinically significant renal, hepatic, neurologic, hematologic, oncologic, pulmonary, psychiatric, cardiovascular or infectious disease, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results
  • Renal dysfunction calculated as creatinine clearance (CrCl) <40 mL/min at screening
  • Hemoglobin A1c >11.5% at screening
  • A history of alcohol or drug abuse within the year prior to the screening visit, or current known evidence of substance dependence or abuse
  • Participation in a clinical (investigational) trial or receipt of a non FDA approved therapy within 30 days prior to the screening visit
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02025751

  Show 40 Study Locations
Sponsors and Collaborators
Evoke Pharma
Investigators
Study Director: Marilyn R Carlson, DMD, MD Evoke Pharma, Inc.
  More Information

No publications provided

Responsible Party: Evoke Pharma
ClinicalTrials.gov Identifier: NCT02025751     History of Changes
Other Study ID Numbers: METO-IN-004
Study First Received: December 29, 2013
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Stomach Diseases
Gastroparesis
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Metoclopramide
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014