Safety and Effectiveness of an Investigational Agent (GM-611) in Patients With Diabetic Gastroparesis
A 12-Week Study Conducted at Multiple Centers, Blinded to Both the Patient and Doctor, Evaluating for Safety and Effectiveness Two Dosages of an Investigational Agent (GM-611) Versus a Placebo, That Are Randomly Assigned to Patients With Diabetic Gastroparesis
1 other identifier
interventional
N/A
1 country
67
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.
Trial Health
Trial Health Score
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67 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 29, 2002
CompletedFirst Posted
Study publicly available on registry
December 31, 2002
CompletedJune 24, 2005
February 1, 2004
December 29, 2002
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (67)
Arizona Center for Clinical Research
Glendale, Arizona, 85306, United States
Lovelace Scientific Resources
Phoenix, Arizona, 85016, United States
AGMG Clinical Research
Anaheim, California, 92801, United States
Orange County Clinical Research, Inc
Cypress, California, 90630, United States
Long Beach VA Medical Center
Long Beach, California, 90822, United States
Research Foundation of America
Los Angeles, California, 90035, United States
Community Clinical Trials
Orange, California, 92868, United States
The Whittier Institute for Diabetes & Endocrinology
San Diego, California, 92037, United States
Sharp Rees-Stealy Medical Group
San Diego, California, 92123, United States
Westlake Medical Research
Westlake Village, California, 91361, United States
Center for Diabetes & Endocrinology
Arvada, Colorado, 80002, United States
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, 80262, United States
Gastroenterology Associates of Manatee, PA
Bradenton, Florida, 34209, United States
Baptist Diabetes Associates
Miami, Florida, 33176, United States
Anchor Research Center
Naples, Florida, 34102, United States
Suncoast Clinical Research
New Port Richey, Florida, 34652, United States
BioQuan Research Group
North Miami, Florida, 33161, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Idaho Gastroenterology Associates
Boise, Idaho, 83702, United States
Radiant Research Boise
Boise, Idaho, 83704, United States
Rocky Mountain Institute of Clinical Research
Idaho Falls, Idaho, 83404, United States
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612, United States
Gastroenterology, Ltd.
Peoria, Illinois, 61602, United States
Rockford Gastroenterology Associates, Ltd
Rockford, Illinois, 61107, United States
St. Vincent Hospital & Health Care Center
Indianapolis, Indiana, 46260, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Professional Research Network of Kansas
Wichita, Kansas, 67203, United States
Digestive Health Center, University of Louisville
Louisville, Kentucky, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112, United States
Medical Research Institute
Slidell, Louisiana, 70458, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Center for Diabetes & Endocrinology
Grand Rapids, Michigan, 49503, United States
Radiant Research
Edina, Minnesota, 55435, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-9941, United States
GI Associates Research
Jackson, Mississippi, United States
University of Nebraska Health Center
Omaha, Nebraska, 68198-2000, United States
Lovelace Scientific Resources c/o Southwest Medical Associates
Las Vegas, Nevada, 89102, United States
Core Health Services, Inc
Hampton, New Hampshire, 03842, United States
Lovelace Scientific Resources, Inc
Albuquerque, New Mexico, 87108, United States
Diabetic Care Associates
Binghamton, New York, 13903, United States
Carolina Digestive Health Associates
Charlotte, North Carolina, 28211, United States
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Prime Care Clinical Research
Clinton, Oklahoma, 73601, United States
Regional Gastroenterology Associates of Lancaster
Lancaster, Pennsylvania, 17601, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Temple University Hospital-GI Section
Philadelphia, Pennsylvania, 19140, United States
Keystone Digestive Disorders Consultants, PC
Pittsburgh, Pennsylvania, 15224, United States
Research Site
Stoneboro, Pennsylvania, 16153, United States
Advanced Clinical Research, Ltd
North Providence, Rhode Island, 02911, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Diabetes Control Center
Orangeburg, South Carolina, 29118, United States
Regional Research Institute
Jackson, Tennessee, 38305, United States
Pharma Tex Research
Amarillo, Texas, United States
Radiant Research-Dallas North
Dallas, Texas, 75231, United States
Pro-Research Group
San Antonio, Texas, 78224, United States
Diabetes & Glandular Disease Research Associates
San Antonio, Texas, 78229, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132-2410, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
McGuire VA Medical Center
Richmond, Virginia, 23249, United States
Evergreen Diabetes & Endocrinology Medical Group
Kirkland, Washington, 98034, United States
Hyperion Clinical Research
Charleston, West Virginia, 25301, United States
University of Wisconsin-Madison
Madison, Wisconsin, 53717-2656, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53207, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 29, 2002
First Posted
December 31, 2002
Last Updated
June 24, 2005
Record last verified: 2004-02