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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetic Gastroparesis

In brief

The purpose of this study is provide confirmation of the safety and efficacy of Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult women.

Key facts

Study ID

NCT02025725

Run by

Evoke Pharma

People needed

205

Starts

2014-03-27

Expected to finish

2016-06-27

Last updated by the study team

2020-07-07

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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

You may not qualify if…

• 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
• 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
• 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

Where it is running

• Birmingham Gasteroenterology Associates, P.C. — Birmingham, Alabama, United States
• Digestive Specialists of the Southeast — Dothan, Alabama, United States
• Clinical Research Associates — Huntsville, Alabama, United States
• Central Arizone Medical Associates/Clinical Research Advantage — Mesa, Arizona, United States
• Preferred Research Partners — Little Rock, Arkansas, United States
• Arkansas Gastroenterology — Sherwood, Arkansas, United States
• Precision Research Institute, LLC — Chula Vista, California, United States
• John Muir Physician Network Clinical Research Center — Concord, California, United States
• Precision Research Institute, LLC — San Diego, California, United States
• The Center for Gastrointestinal Disorders — Hollywood, Florida, United States
• Nature Coast Clinical Research — Inverness, Florida, United States
• International Research Associates, LLC — Miami, Florida, United States
• Advanced Medical Research — Port Orange, Florida, United States
• Tri-County Research — Athens, Georgia, United States
• Digestive Healthcare of Georgia — Atlanta, Georgia, United States
• Newton Medical Center — Conyers, Georgia, United States
• Gastrointestinal Specialists of Georgia, PC — Marietta, Georgia, United States
• Atlanta Gastroenterology Associates — Marietta, Georgia, United States
• Southwest Gastroenterology — Oak Lawn, Illinois, United States
• Indiana University Health UH 1634 — Indianapolis, Indiana, United States
• Professional Research Network of Kansas — Wichita, Kansas, United States
• Gastroenterology Associates, LLC — Baton Rouge, Louisiana, United States
• Delta Research Partners, LLC — Monroe, Louisiana, United States
• Clinical Research Institute of Michigan — Chesterfield, Michigan, United States
• Center for Digestive Health — Troy, Michigan, United States

Full record on ClinicalTrials.gov

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