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

June 23, 2005 updated by: Chugai Pharma USA

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chugai Pharma USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 29, 2002

First Submitted That Met QC Criteria

December 30, 2002

First Posted (Estimate)

December 31, 2002

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

February 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GM-611-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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