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

NCT ID: NCT00845858

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 287 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-12-31

Brief Summary

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.

Conditions

Gastroparesis; Diabetic Gastroparesis; Diabetes; Diabetes Mellitus; Delayed Gastric Emptying

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Metoclopramide Nasal Spray 10 mg

Group Type: ACTIVE_COMPARATOR

metoclopramide

Intervention Type: DRUG

30 minutes before meals and at bedtime for 4 weeks

Metoclopramide Nasal Spray 14 mg

Group Type: ACTIVE_COMPARATOR

metoclopramide

Intervention Type: DRUG

30 minutes before meals and at bedtime for 4 weeks

Placebo Nasal Spray

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

30 minutes before meals and at bedtime

Interventions

metoclopramide

30 minutes before meals and at bedtime for 4 weeks

Intervention Type: DRUG

Placebo

30 minutes before meals and at bedtime

Intervention Type: DRUG

Other Intervention Names

Reglan

Eligibility Criteria

Inclusion Criteria

1. Male subjects and non-pregnant, non-lactating female subjects between the ages of 18 and 75 years (inclusive)

2. Willing and able to give written informed consent to participate in the study

3. Ability to read and understand English

4. Diagnosis of Type 1 or Type 2 diabetes

5. Diagnosis of diabetic gastroparesis previously documented

6. A mean daily GCSI-DD score of ≥2 and ≤4 for the 7 days prior to the Randomization Visit (Visit 3, Day 0)

7. 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)

8. 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

9. Willingness to discontinue current treatment for diabetic gastroparesis and to avoid all medications specified by the protocol for the duration of the study

Exclusion Criteria

1. 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

2. 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

3. History of or physical findings suggestive of tardive dyskinesia

4. 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)

5. History of allergy to any of the ingredients in the study drug formulation; metoclopramide, citric acid, sodium citrate, benzalkonium chloride, EDTA, or sorbitol

6. History of organ transplant, chronic pancreatitis, gross malabsorptive syndromes, celiac disease, or inflammatory bowel disease

7. Malignancy (with the exception of basal cell carcinoma of the skin) currently present, initially diagnosed or recurring within 5 years of enrollment

8. 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

9. Have renal dysfunction calculated as creatinine clearance (CrCl) < 40 mL/min at Screening (Visit 1)

10. Have a hemoglobin A1c > 12.5% at Screening (Visit 1)

11. 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

12. 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)

13. 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)

14. 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)

15. Female subjects who are trying to conceive, are pregnant, or are lactating

16. 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

17. History of alcohol or drug abuse within the year prior to the Screening Visit, or current known evidence of substance dependence or abuse

18. 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evoke Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Digestive Specialists of the Southeast

Dothan, Alabama, United States

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

Metropolitan Gastroenterology Group

Chevy Chase, Maryland, United States

Maryland Digestive Disease Research, LLC

Laurel, Maryland, United States

Endoscopic Microsurgery Associates

Towson, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Plymouth Clinic

Plymouth, Minnesota, United States

CRC of Jackson, LLC

Jackson, Mississippi, United States

Gastrointestional Associates

Jackson, Mississippi, United States

Digestive Health Specialists

Tupelo, Mississippi, United States

Kansas City Gastroenterology & Hepatology

Kansas City, Missouri, United States

Center for Digestive and Liver Diseases, Inc.

Mexico, Missouri, United States

Lovelace Scientific Resources, Inc.

Albuquerque, New Mexico, United States

Medex Healthcare Research, Inc.

New York, New York, United States

Research Associates of New York

New York, New York, United States

Gastroenterology Associates

Poughkeepsie, New York, United States

Cumberland Research Associates

Fayetteville, North Carolina, United States

LeBauer Research Associates

Greensboro, North Carolina, United States

Wake Research Associates

Raleigh, North Carolina, United States

Hanover Medical Specialists

Wilmington, North Carolina, United States

Piedmont Medical Research

Winston-Salem, North Carolina, United States

AGA

Akron, Ohio, United States

Consultants for Clinical Research

Cincinnati, Ohio, United States

Hightop Medical Research Center

Cincinnati, Ohio, United States

Great Lakes Gastroenterology

Mentor, Ohio, United States

Regional Gastroenterology Associates of Lancaster, Ltd.

Lancaster, Pennsylvania, United States

PMA Medical Specialists

Limerick, Pennsylvania, United States

Memphis Gastroenterology Group

Germantown, Tennessee, United States

HCCA Clinical Research Solutions

Jackson, Tennessee, United States

Medical Specialty Clinic Research

Jackson, Tennessee, United States

Holston Medical Group, PC

Kingsport, Tennessee, United States

Lovelace Scientific Resources

Austin, Texas, United States

Jacinto Medical Group

Baytown (Houston), Texas, United States

Dynamed Clinical Research

Houston, Texas, United States

Digestive Health Associates of Texas, P.A.

Plano, Texas, United States

Theda Oaks Endoscopy Center

San Antonio, Texas, United States

Trinity Health Care

Tyler, Texas, United States

Charlottesville Medical Research

Charlottesville, Virginia, United States

Gastroenterology Associates of Tidewater

Chesapeake, Virginia, United States

Digestive and Liver Disease Specialists

Norfolk, Virginia, United States

Gastroenterology, Ltd.

Virginia Beach, Virginia, United States

Wisconsin Center for Advanced Research

Milwaukee, Wisconsin, United States

Countries

United States

References

Parkman HP, Carlson MR, Gonyer D. Metoclopramide Nasal Spray Reduces Symptoms of Gastroparesis in Women, but not Men, With Diabetes: Results of a Phase 2B Randomized Study. Clin Gastroenterol Hepatol. 2015 Jul;13(7):1256-1263.e1. doi: 10.1016/j.cgh.2014.12.030. Epub 2015 Jan 7.

Reference Type: DERIVED

PMID: 25576687 (View on PubMed)

Other Identifiers

METO-IN-002

Identifier Type: -

Identifier Source: org_study_id