Safety and Effectiveness of an Investigational Agent (GM-611) in Patients With Diabetic Gastroparesis
- Conditions
- Gastroparesis
- Registration Number
- NCT00050882
- Lead Sponsor
- Chugai Pharma USA
- Brief Summary
This study is intended to evaluate the potential to relieve the symptoms associated with gastroparesis during 12 weeks of treatment with oral tablets given twice a day of GM-611 5mg, 10mg or placebo to type I or II diabetics who require insulin.
Additionally the study will evaluate the safety and tolerability of GM-611 compared to placebo, the levels of GM-611 in the blood, and the possible effect of GM-611 on diabetic control.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Major Inclusion Criteria - Others Stipulated within the Protocol
The study physician must assure you have/are:
- Must be at least 18 years of age and have diabetes mellitus requiring insulin, which may be in addition to oral anti-diabetic agents.
- At least a three month history of the symptoms of gastroparesis that may include: early satiety (feeling full soon after beginning a meal), persistent fullness (long after eating), abdominal distention or bloating, nausea and vomiting. - No evidence of mechanical gastric obstruction, or other gastric problems since the onset of gastroparesis symptoms.
- You may be required to under go a Gastric Emptying Test (GET) procedure.
- You must be willing and able to maintain a daily telephone diary and consent to participate in this study.
Major Exclusion Criteria - Others Stipulated within the Protocol
The study physician must assure you do not have/are not:
- Prior history of gastric surgery, excluding reflux surgery.
- Inability to withdraw from current prokinetic agents (e.g., metoclopramide, erythromycin, others) prior to, and during the study.
- Unstable current medical or surgical condition, or a recent history of frequent hospitalizations.
- A history of: HIV, recurring infection affecting the gastrointestinal track, cirrhosis, acute or chronic liver disease, active pancreatitis, cholecystitis, psychosis, severe depression, Parkinson's disease, myopathy, scleroderma, eating disorder, or organ transplant.
- Evidence or history of QT-prolongation, or use of drugs that are, or may be associated with QT-prolongation are prohibited.
- May not be pregnant, breast-feeding or not using approved methods of contraception.
- An allergy or intolerance to macrolide antibiotics (e.g., erythromycin).
- Use of any investigational drug within 30 days prior to screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (66)
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Rocky Mountain Institute of Clinical Research
🇺🇸Idaho Falls, Idaho, United States
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
Baptist Diabetes Associates
🇺🇸Miami, Florida, United States
The Whittier Institute for Diabetes & Endocrinology
🇺🇸San Diego, California, United States
St. Vincent Hospital & Health Care Center
🇺🇸Indianapolis, Indiana, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Keystone Digestive Disorders Consultants, PC
🇺🇸Pittsburg, Pennsylvania, United States
Pro-Research Group
🇺🇸San Antonio, Texas, United States
Diabetes & Glandular Disease Research Associates
🇺🇸San Antonio, Texas, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Anchor Research Center
🇺🇸Naples, Florida, United States
Suncoast Clinical Research
🇺🇸New Port Richey, Florida, United States
BioQuan Research Group
🇺🇸North Miami, Florida, United States
Lovelace Scientific Resources
🇺🇸Phoenix, Arizona, United States
Arizona Center for Clinical Research
🇺🇸Glendale, Arizona, United States
AGMG Clinical Research
🇺🇸Anaheim, California, United States
Sharp Rees-Stealy Medical Group
🇺🇸San Diego, California, United States
Long Beach VA Medical Center
🇺🇸Long Beach, California, United States
Westlake Medical Research
🇺🇸Westlake Village, California, United States
Orange County Clinical Research, Inc
🇺🇸Cypress, California, United States
Research Foundation of America
🇺🇸Los Angeles, California, United States
Community Clinical Trials
🇺🇸Orange, California, United States
Gastroenterology Associates of Manatee, PA
🇺🇸Bradenton, Florida, United States
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Idaho Gastroenterology Associates
🇺🇸Boise, Idaho, United States
Radiant Research Boise
🇺🇸Boise, Idaho, United States
Rush Presbyterian St. Luke's Medical Center
🇺🇸Chicago, Illinois, United States
Gastroenterology, Ltd.
🇺🇸Peoria, Illinois, United States
Rockford Gastroenterology Associates, Ltd
🇺🇸Rockford, Illinois, United States
Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Professional Research Network of Kansas
🇺🇸Wichita, Kansas, United States
Tulane University Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Digestive Health Specialists, PA
🇺🇸Winston Salem, North Carolina, United States
Lovelace Scientific Resources, Inc
🇺🇸Albuquerque, New Mexico, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Lovelace Scientific Resources c/o Southwest Medical Associates
🇺🇸Las Vegas, Nevada, United States
Medical Research Institute
🇺🇸Slidell, Louisiana, United States
Regional Gastroenterology Associates of Lancaster
🇺🇸Lancaster, Pennsylvania, United States
Core Health Services, Inc
🇺🇸Hampton, New Hampshire, United States
Prime Care Clinical Research
🇺🇸Clinton, Oklahoma, United States
Diabetic Care Associates
🇺🇸Binghamton, New York, United States
Temple University Hospital-GI Section
🇺🇸Philadelphia, Pennsylvania, United States
Advanced Clinical Research, Ltd
🇺🇸North Providence, Rhode Island, United States
Pharma Tex Research
🇺🇸Amarillo, Texas, United States
Radiant Research-Dallas North
🇺🇸Dallas, Texas, United States
Research Site
🇺🇸Stoneboro, Pennsylvania, United States
Diabetes Control Center
🇺🇸Orangeburg, South Carolina, United States
Regional Research Institute
🇺🇸Jackson, Tennessee, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
Center for Diabetes & Endocrinology
🇺🇸Grand Rapids, Michigan, United States
GI Associates Research
🇺🇸Jackson, Mississippi, United States
Carolina Digestive Health Associates
🇺🇸Charlotte, North Carolina, United States
Hyperion Clinical Research
🇺🇸Charleston, West Virginia, United States
Evergreen Diabetes & Endocrinology Medical Group
🇺🇸Kirkland, Washington, United States
University of Wisconsin-Madison
🇺🇸Madison, Wisconsin, United States
Barbara Davis Center for Childhood Diabetes
🇺🇸Denver, Colorado, United States
Digestive Health Center, University of Louisville
🇺🇸Louisville, Kentucky, United States
University of Nebraska Health Center
🇺🇸Omaha, Nebraska, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Radiant Research
🇺🇸Edina, Minnesota, United States