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

Primary Purpose

Gastroparesis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GM-611
Sponsored by
Chugai Pharma USA
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis focused on measuring GM-611, Diabetic gastroparesis, Bloating, Delayed gastric emptying, Mitemcinal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Center for Clinical Research
  • Lovelace Scientific Resources
  • AGMG Clinical Research
  • Orange County Clinical Research, Inc
  • Long Beach VA Medical Center
  • Research Foundation of America
  • Community Clinical Trials
  • The Whittier Institute for Diabetes & Endocrinology
  • Sharp Rees-Stealy Medical Group
  • Westlake Medical Research
  • Center for Diabetes & Endocrinology
  • Barbara Davis Center for Childhood Diabetes
  • Gastroenterology Associates of Manatee, PA
  • Baptist Diabetes Associates
  • Anchor Research Center
  • Suncoast Clinical Research
  • BioQuan Research Group
  • Palm Beach Research Center
  • Emory University School of Medicine
  • Idaho Gastroenterology Associates
  • Radiant Research Boise
  • Rocky Mountain Institute of Clinical Research
  • Rush Presbyterian St. Luke's Medical Center
  • Gastroenterology, Ltd.
  • Rockford Gastroenterology Associates, Ltd
  • St. Vincent Hospital & Health Care Center
  • University of Kansas Medical Center
  • Professional Research Network of Kansas
  • Digestive Health Center, University of Louisville
  • Tulane University Health Sciences Center
  • Medical Research Institute
  • Chevy Chase Clinical Research
  • Henry Ford Hospital
  • Center for Diabetes & Endocrinology
  • Radiant Research
  • University of Mississippi Medical Center
  • GI Associates Research
  • University of Nebraska Health Center
  • Lovelace Scientific Resources c/o Southwest Medical Associates
  • Core Health Services, Inc
  • Lovelace Scientific Resources, Inc
  • Diabetic Care Associates
  • Carolina Digestive Health Associates
  • Digestive Health Specialists, PA
  • Consultants for Clinical Research
  • Cleveland Clinic Foundation
  • Prime Care Clinical Research
  • Regional Gastroenterology Associates of Lancaster
  • Thomas Jefferson University
  • Temple University Hospital-GI Section
  • Keystone Digestive Disorders Consultants, PC
  • Research Site
  • Advanced Clinical Research, Ltd
  • Medical University of South Carolina
  • Diabetes Control Center
  • Regional Research Institute
  • Pharma Tex Research
  • Radiant Research-Dallas North
  • Pro-Research Group
  • Diabetes & Glandular Disease Research Associates
  • University of Utah Health Sciences Center
  • Metropolitan Research
  • McGuire VA Medical Center
  • Evergreen Diabetes & Endocrinology Medical Group
  • Hyperion Clinical Research
  • University of Wisconsin-Madison
  • Wisconsin Center for Advanced Research

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
December 29, 2002
Last Updated
June 23, 2005
Sponsor
Chugai Pharma USA
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1. Study Identification

Unique Protocol Identification Number
NCT00050882
Brief Title
Safety and Effectiveness of an Investigational Agent (GM-611) in Patients With Diabetic Gastroparesis
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2004
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Chugai Pharma USA

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis
Keywords
GM-611, Diabetic gastroparesis, Bloating, Delayed gastric emptying, Mitemcinal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GM-611

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Arizona Center for Clinical Research
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Lovelace Scientific Resources
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
AGMG Clinical Research
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Orange County Clinical Research, Inc
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Facility Name
Long Beach VA Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Research Foundation of America
City
Los Angeles
State/Province
California
ZIP/Postal Code
90035
Country
United States
Facility Name
Community Clinical Trials
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
The Whittier Institute for Diabetes & Endocrinology
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Sharp Rees-Stealy Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Westlake Medical Research
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Center for Diabetes & Endocrinology
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80002
Country
United States
Facility Name
Barbara Davis Center for Childhood Diabetes
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Gastroenterology Associates of Manatee, PA
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Baptist Diabetes Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Anchor Research Center
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Suncoast Clinical Research
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
BioQuan Research Group
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Idaho Gastroenterology Associates
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Radiant Research Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Rocky Mountain Institute of Clinical Research
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Rush Presbyterian St. Luke's Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Gastroenterology, Ltd.
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Rockford Gastroenterology Associates, Ltd
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
St. Vincent Hospital & Health Care Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Professional Research Network of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Digestive Health Center, University of Louisville
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Tulane University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Medical Research Institute
City
Slidell
State/Province
Louisiana
ZIP/Postal Code
70458
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Center for Diabetes & Endocrinology
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Radiant Research
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-9941
Country
United States
Facility Name
GI Associates Research
City
Jackson
State/Province
Mississippi
Country
United States
Facility Name
University of Nebraska Health Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-2000
Country
United States
Facility Name
Lovelace Scientific Resources c/o Southwest Medical Associates
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Core Health Services, Inc
City
Hampton
State/Province
New Hampshire
ZIP/Postal Code
03842
Country
United States
Facility Name
Lovelace Scientific Resources, Inc
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Diabetic Care Associates
City
Binghamton
State/Province
New York
ZIP/Postal Code
13903
Country
United States
Facility Name
Carolina Digestive Health Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Digestive Health Specialists, PA
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Prime Care Clinical Research
City
Clinton
State/Province
Oklahoma
ZIP/Postal Code
73601
Country
United States
Facility Name
Regional Gastroenterology Associates of Lancaster
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple University Hospital-GI Section
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Keystone Digestive Disorders Consultants, PC
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Research Site
City
Stoneboro
State/Province
Pennsylvania
ZIP/Postal Code
16153
Country
United States
Facility Name
Advanced Clinical Research, Ltd
City
North Providence
State/Province
Rhode Island
ZIP/Postal Code
02911
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Diabetes Control Center
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Regional Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Pharma Tex Research
City
Amarillo
State/Province
Texas
Country
United States
Facility Name
Radiant Research-Dallas North
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pro-Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78224
Country
United States
Facility Name
Diabetes & Glandular Disease Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132-2410
Country
United States
Facility Name
Metropolitan Research
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
Evergreen Diabetes & Endocrinology Medical Group
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Hyperion Clinical Research
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717-2656
Country
United States
Facility Name
Wisconsin Center for Advanced Research
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53207
Country
United States

12. IPD Sharing Statement

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

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