Safety and Effectiveness of an Investigational Agent (GM-611) in Patients With Diabetic Gastroparesis

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharma USA
ClinicalTrials.gov Identifier:
NCT00050882
First received: December 29, 2002
Last updated: June 23, 2005
Last verified: February 2004
  Purpose

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.


Condition Intervention Phase
Gastroparesis
Drug: GM-611
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Chugai Pharma USA:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00050882

  Hide Study Locations
Locations
United States, Arizona
Arizona Center for Clinical Research
Glendale, Arizona, United States, 85306
Lovelace Scientific Resources
Phoenix, Arizona, United States, 85016
United States, California
AGMG Clinical Research
Anaheim, California, United States, 92801
Orange County Clinical Research, Inc
Cypress, California, United States, 90630
Long Beach VA Medical Center
Long Beach, California, United States, 90822
Research Foundation of America
Los Angeles, California, United States, 90035
Community Clinical Trials
Orange, California, United States, 92868
The Whittier Institute for Diabetes & Endocrinology
San Diego, California, United States, 92037
Sharp Rees-Stealy Medical Group
San Diego, California, United States, 92123
Westlake Medical Research
Westlake Village, California, United States, 91361
United States, Colorado
Center for Diabetes & Endocrinology
Arvada, Colorado, United States, 80002
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, United States, 80262
United States, Florida
Gastroenterology Associates of Manatee, PA
Bradenton, Florida, United States, 34209
Baptist Diabetes Associates
Miami, Florida, United States, 33176
Anchor Research Center
Naples, Florida, United States, 34102
Suncoast Clinical Research
New Port Richey, Florida, United States, 34652
BioQuan Research Group
North Miami, Florida, United States, 33161
Palm Beach Research Center
West Palm Beach, Florida, United States, 33409
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States
United States, Idaho
Idaho Gastroenterology Associates
Boise, Idaho, United States, 83702
Radiant Research Boise
Boise, Idaho, United States, 83704
Rocky Mountain Institute of Clinical Research
Idaho Falls, Idaho, United States, 83404
United States, Illinois
Rush Presbyterian St. Luke's Medical Center
Chicago, Illinois, United States, 60612
Gastroenterology, Ltd.
Peoria, Illinois, United States, 61602
Rockford Gastroenterology Associates, Ltd
Rockford, Illinois, United States, 61107
United States, Indiana
St. Vincent Hospital & Health Care Center
Indianapolis, Indiana, United States, 46260
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Professional Research Network of Kansas
Wichita, Kansas, United States, 67203
United States, Kentucky
Digestive Health Center, University of Louisville
Louisville, Kentucky, United States
United States, Louisiana
Tulane University Health Sciences Center
New Orleans, Louisiana, United States, 70112
Medical Research Institute
Slidell, Louisiana, United States, 70458
United States, Maryland
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Center for Diabetes & Endocrinology
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Radiant Research
Edina, Minnesota, United States, 55435
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-9941
GI Associates Research
Jackson, Mississippi, United States
United States, Nebraska
University of Nebraska Health Center
Omaha, Nebraska, United States, 68198-2000
United States, Nevada
Lovelace Scientific Resources c/o Southwest Medical Associates
Las Vegas, Nevada, United States, 89102
United States, New Hampshire
Core Health Services, Inc
Hampton, New Hampshire, United States, 03842
United States, New Mexico
Lovelace Scientific Resources, Inc
Albuquerque, New Mexico, United States, 87108
United States, New York
Diabetic Care Associates
Binghamton, New York, United States, 13903
United States, North Carolina
Carolina Digestive Health Associates
Charlotte, North Carolina, United States, 28211
Digestive Health Specialists, PA
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Consultants for Clinical Research
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Prime Care Clinical Research
Clinton, Oklahoma, United States, 73601
United States, Pennsylvania
Regional Gastroenterology Associates of Lancaster
Lancaster, Pennsylvania, United States, 17601
Temple University Hospital-GI Section
Philadelphia, Pennsylvania, United States, 19140
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Keystone Digestive Disorders Consultants, PC
Pittsburg, Pennsylvania, United States, 15224
Research Site
Stoneboro, Pennsylvania, United States, 16153
United States, Rhode Island
Advanced Clinical Research, Ltd
North Providence, Rhode Island, United States, 02911
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Diabetes Control Center
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
Regional Research Institute
Jackson, Tennessee, United States, 38305
United States, Texas
Pharma Tex Research
Amarillo, Texas, United States
Radiant Research-Dallas North
Dallas, Texas, United States, 75231
Diabetes & Glandular Disease Research Associates
San Antonio, Texas, United States, 78229
Pro-Research Group
San Antonio, Texas, United States, 78224
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132-2410
United States, Virginia
Metropolitan Research
Fairfax, Virginia, United States, 22031
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
United States, Washington
Evergreen Diabetes & Endocrinology Medical Group
Kirkland, Washington, United States, 98034
United States, West Virginia
Hyperion Clinical Research
Charleston, West Virginia, United States, 25301
United States, Wisconsin
University of Wisconsin-Madison
Madison, Wisconsin, United States, 53717-2656
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53207
Sponsors and Collaborators
Chugai Pharma USA
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00050882     History of Changes
Other Study ID Numbers: GM-611-05
Study First Received: December 29, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Chugai Pharma USA:
GM-611
Diabetic gastroparesis
Bloating
Delayed gastric emptying
Mitemcinal

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014