Diabetic Gastroparesis in Men

  • sponsor
    Evoke Pharma, Inc.
Updated on 25 March 2021


Diabetic Gastroparesis in Men


METO-IN-004 : A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men with symptoms associated with Diabetic Gastroparesis.

Condition Diabetic Gastroparesis
Clinical Study IdentifierTX139784
SponsorEvoke Pharma, Inc.
Last Modified on25 March 2021


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact



Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note