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Safety and effectiveness of an investigational agent (GM-611) in patients with diabetic gastroparesis Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Safety and effectiveness of an investigational agent (GM-611) in patients with diabetic gastroparesis conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Safety and effectiveness of an investigational agent (GM-611) in patients with diabetic gastroparesis Clinical research trials and Safety and effectiveness of an investigational agent (GM-611) in patients with diabetic gastroparesis healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Safety and effectiveness of an investigational agent (GM-611) in patients with diabetic gastroparesis. Safety and effectiveness of an investigational agent (GM-611) in patients with diabetic gastroparesis Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Safety and effectiveness of an investigational agent (GM-611) in patients with diabetic gastroparesis clinical trial. Participants typically obtain the most effective healthcare available for their Safety and effectiveness of an investigational agent (GM-611) in patients with diabetic gastroparesis condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "S" Clinical Trials Conditions > Safety and effectiveness of an investigational agent (GM-611) in patients with diabetic gastroparesis  Safety and effectiveness of an investigational agent (GM-611) in patients with diabetic gastroparesis
Safety and effectiveness of an investigational agent (GM-611) in patients with diabetic gastroparesis
For Condition: Gastroparesis
Status: Completed
Sponsor(s): Chugai Pharma USA ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: 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. Exclusion Criteria: 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.
Total Enrollment:
Location and Contact Information:
Metropolitan Research
Fairfax, Virginia, 22031
United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219
United States
Evergreen Diabetes & Endocrinology Medical Group
Kirkland, Washington, 98034
United States
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132-2410
United States
The Whittier Institute for Diabetes & Endocrinology
San Diego, California, 92037
United States
Anchor Research Center
Naples, Florida, 34102
United States
Emory University School of Medicine
Atlanta, Georgia,
United States
Gastroenterology Associates of Manatee, PA
Bradenton, Florida, 34209
United States
Prime Care Clinical Research
Clinton, Oklahoma, 73601
United States
Professional Research Network of Kansas
Wichita, Kansas, 67203
United States
Advanced Clinical Research, Ltd
Providence, Rhode Island, 02911
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Keystone Digestive Disorders Consultants, PC
Pittsburgh, Pennsylvania, 15224
United States
Suncoast Clinical Research
New Port Richey, Florida, 34652
United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53207
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Radiant Research Boise
Boise, Idaho, 83704
United States
Digestive Health Specialists, PA
Winston Salem, North Carolina, 27103
United States
Regional Research Institute
Jackson, Tennessee, 38305
United States
Idaho Gastroenterology Associates
Boise, Idaho, 83702
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Pro-Research Group
San Antonio, Texas, 78224
United States
Carolina Digestive Health Associates
Charlotte, North Carolina, 28211
United States
GI Associates Research
Jackson, Mississippi,
United States
McGuire VA Medical Center
Richmond, Virginia, 23249
United States
Baptist Diabetes Associates
Miami, Florida, 33176
United States
University of Wisconsin-Madison
Madison, Wisconsin, 53717-2656
United States
Radiant Research
Edina, Minnesota, 55435
United States
Community Clinical Trials
Orange, California, 92868
United States
Sharp Rees-Stealy Medical Group
San Diego, California, 92123
United States
Regional Gastroenterology Associates of Lancaster
Lancaster, Pennsylvania, 17601
United States
Center for Diabetes & Endocrinology
Grand Rapids, Michigan, 49503
United States
Suncoast Clinical Research
New Port Richey, Florida, 34652
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-9941
United States
Research Foundation of America
Los Angeles, California, 90035
United States
Palm Beach Research Center
West Palm Beach, Florida, 33409
United States
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Core Health Services, Inc
Hampton, New Hampshire, 03842
United States
Center for Diabetes & Endocrinology
Arvada, Colorado, 80002
United States
Medical Research Institute
Slidell, Louisiana, 70458
United States
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
United States
Diabetic Care Associates
Binghamton, New York, 13903
United States
Long Beach VA Medical Center
Long Beach, California, 90822
United States
Research Site
Stoneboro, Pennsylvania, 16153
United States
BioQuan Research Group
Miami, Florida, 33161
United States
Lovelace Scientific Resources
Phoenix, Arizona, 85016
United States
Gastroenterology, Ltd.
Peoria, Illinois, 61602
United States
Lovelace Scientific Resources c/o Southwest Medical Associates
Las Vegas, Nevada, 89102
United States
Orange County Clinical Research, Inc
Cypress, California, 90630
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Hyperion Clinical Research
Charleston, West Virginia, 25301
United States
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, 80262
United States
Pharma Tex Research
Amarillo, Texas,
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Diabetes & Glandular Disease Research Associates
San Antonio, Texas, 78229
United States
Diabetes Control Center
Orangeburg, South Carolina, 29118
United States
Rockford Gastroenterology Associates, Ltd
Rockford, Illinois, 61107
United States
University of Nebraska Health Center
Omaha, Nebraska, 68198-2000
United States
Arizona Center for Clinical Research
Glendale, Arizona, 85306
United States
St. Vincent Hospital & Health Care Center
Indianapolis, Indiana, 46260
United States
Westlake Medical Research
Westlake Village, California, 91361
United States
Lovelace Scientific Resources, Inc
Albuquerque, New Mexico, 87108
United States
Digestive Health Center, University of Louisville
Louisville, Kentucky,
United States
AGMG Clinical Research
Anaheim, California, 92801
United States
Rocky Mountain Institute of Clinical Research
Idaho Falls, Idaho, 83404
United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
United States
Temple University Hospital-GI Section
Philadelphia, Pennsylvania, 19140
United States
Radiant Research-Dallas North
Dallas, Texas, 75231
United States
Additional Information:
Study ID Numbers: GM-611-05;
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00050882
Other Gastroparesis Studies:
1. Safety and effectiveness of an investigational agent (GM-611) in patients with diabetic gastroparesis
2. A Study of IC351 (tadalafil) for the treatment of diabetic patients with symptoms of dyspepsia (upset stomach) and gastroparesis (delayed gastric emptying).
Related Studies:
Other Gastroparesis Clinical Trials
Other New York Clinical Trials
Other Binghamton Clinical Trials
Safety and effectiveness of an investigational agent (GM-611) in patients with diabetic gastroparesis
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