Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis

Completed · Phase 2 · Has a placebo group

Conditions studied: Gastroparesis, Diabetic Gastroparesis, Diabetes, Diabetes Mellitus, Delayed Gastric Emptying

In brief

To evaluate the safety and the effectiveness of two doses of metoclopramide nasal spray solution, 10 mg and 14 mg, compared to placebo in reducing the symptoms of diabetic gastroparesis.

Key facts

Study ID

NCT00845858

Run by

Evoke Pharma

People needed

287

Starts

2009-04-01

Expected to finish

2011-12-01

Last updated by the study team

2014-06-27

Who can join

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

You may qualify if…

• Male subjects and non-pregnant, non-lactating female subjects between the ages of 18 and 75 years (inclusive)
• Willing and able to give written informed consent to participate in the study
• Ability to read and understand English
• Diagnosis of Type 1 or Type 2 diabetes
• Diagnosis of diabetic gastroparesis previously documented
• A mean daily GCSI-DD score of ≥2 and ≤4 for the 7 days prior to the Randomization Visit (Visit 3, Day 0)
• Female subjects of childbearing potential, defined as not surgically sterile or at least 2 years postmenopausal, must agree to use one of the following forms of contraception from Screening through the last dose of study drug: hormonal (oral, implant, or injection) begun >30 days prior to screening, barrier (condom, diaphragm, or cervical cap with spermicide), intrauterine device (IUD), or vasectomized partner (6-months minimum)
• No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results (with the exception of lipid profile, glucose and hemoglobin A1c) during screening which, in the opinion of the Investigator, would 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 medications specified by the protocol for the duration of the study

You may not qualify if…

• Gastric bypass and gastric banding, gastric pacemakers, post-surgical causes of gastroparesis and disorders known to be associated with abnormal gastrointestinal motility such as active gastric ulcer, active duodenal ulcer, active severe gastritis, gastric cancer, amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, alcoholism, uremia, malnutrition, and untreated hypothyroidism
• 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
• History of or physical findings suggestive of tardive dyskinesia
• Currently using and unwilling or unable to stop any medication known to be associated with tardive dyskinesia (See Study Reference Manual) prior to Washout (Visit 2)
• History of allergy to any of the ingredients in the study drug formulation; metoclopramide, citric acid, sodium citrate, benzalkonium chloride, EDTA, or sorbitol
• History of organ transplant, chronic pancreatitis, gross malabsorptive syndromes, celiac disease, or inflammatory bowel disease
• Malignancy (with the exception of basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within 5 years of enrollment
• 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
• Have renal dysfunction calculated as creatinine clearance (CrCl) < 40 mL/min at Screening (Visit 1)
• Have a hemoglobin A1c > 12.5% at Screening (Visit 1)
• Inability or unwillingness to stop using the following agents for 7 days during the Washout Period (Day -7 to Day -1) prior to Randomization (Visit 3, Day 0) and refrain from their use for the 4-week study period; oral and parenteral formulations of metoclopramide, domperidone, tricyclic antidepressants, macrolide antibiotics, prokinetic agents, cholinergic agents, agents with significant anticholinergic effects, narcotic analgesics, orally administered β agonists, spasmolytics, dopamine agonists, monoamine oxidase inhibitors, herbal supplements, fiber or bulking products, and laxatives
• Use of neurotoxins (e.g., botulinum type A or B) as a treatment for gastroparesis or delayed gastric emptying within 6 months of Screening (Visit 1)
• Clinically significant abnormal finding or a QTc interval >450 milliseconds (msec) on ECGs obtained at Screening (Visit 1) OR pre- or post-dose at Randomization (Visit 3)
• Inability or unwillingness to stop using medications associated with Torsades de Pointes or a prolonged QT interval for 30 days prior to the initial symptom assessment and refrain from their use for the 4-week study period (see Study Reference Manual)
• Female 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 prior to administration of study drug for women of childbearing potential
• 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 (Visit 1) with the exception of domperidone

Where it is running

• Clinical Research Associates — Huntsville, Alabama, United States
• Medical Affiliated Research Center, Inc. — Huntsville, Alabama, United States
• Desert Sun Gastroenterology — Tucson, Arizona, United States
• Clopton Clinic — Jonesboro, Arkansas, United States
• Arkansas Gastroenterology — Sherwood, Arkansas, United States
• Robert M. Karns, MD, a Medical Corporation — Beverly Hills, California, United States
• VA Long Beach Healthcare System — Long Beach, California, United States
• Impact Clinical Trials — Los Angeles, California, United States
• Prime-Care Clinical Research — Mission Viejo, California, United States
• Infosphere Clinical Research, Inc. — West Hills, California, United States
• Westlake Medical Research — Westlake Village, California, United States
• Consultants for Clinical Research of South Florida — Boynton Beach, Florida, United States
• Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
• Nature Coast Clinical Research — Inverness, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• AppleMed Research, Inc. — Miami, Florida, United States
• International Research Associates, LLC — Miami, Florida, United States
• Newton Medical Center — Conyers, Georgia, United States
• Gastrointestinal Specialists of Georgia — Marietta, Georgia, United States
• Rockford Gastroenterology Associates — Rockford, Illinois, United States
• Saint John's Research Institute — Anderson, Indiana, United States
• Cotton-O'Neil Clinical Research Center — Topeka, Kansas, United States
• Professional Research Network of Kansas — Wichita, Kansas, United States
• Delta Research Partners, LLC — Monroe, Louisiana, United States
• Digestive Specialists of the Southeast — Dothan, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.