Diabetic Gastroparesis in Women

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

Summary

Diabetic Gastroparesis in Women

Description

METO-IN-003 : A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women with symptoms associated with Diabetic Gastroparesis.

Details
Condition Diabetic Gastroparesis
Clinical Study IdentifierTX139791
SponsorEvoke Pharma, Inc.
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

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
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
Subjects who are trying to conceive, are pregnant, or are lactating
Positive serum human chorionic gonadotropin (HCG) pregnancy test at screening or a positive HCG urine test on Day 0
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
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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.

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