Clinical trial NCT00050882: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroparesis
Keywords: GM-611
Diabetic gastroparesis
Bloating
Delayed gastric emptying
Mitemcinal
Lead sponsor: Chugai Pharma USA
Sponsor class: INDUSTRY
First posted: 2002-12-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Arizona Center for Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Lovelace Scientific Resources
state: Arizona
city: Anaheim
country: United States
facility: AGMG Clinical Research
state: California
city: Cypress
country: United States
facility: Orange County Clinical Research, Inc
state: California
city: Long Beach
country: United States
facility: Long Beach VA Medical Center
state: California
city: Los Angeles
country: United States
facility: Research Foundation of America
state: California
city: Orange
country: United States
facility: Community Clinical Trials
state: California
city: San Diego
country: United States
facility: The Whittier Institute for Diabetes & Endocrinology
state: California
city: San Diego
country: United States
facility: Sharp Rees-Stealy Medical Group
state: California
city: Westlake Village
country: United States
facility: Westlake Medical Research
state: California
city: Arvada
country: United States
facility: Center for Diabetes & Endocrinology
state: Colorado
city: Denver
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
city: Bradenton
country: United States
facility: Gastroenterology Associates of Manatee, PA
state: Florida
city: Miami
country: United States
facility: Baptist Diabetes Associates
state: Florida
city: Naples
country: United States
facility: Anchor Research Center
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: North Miami
country: United States
facility: BioQuan Research Group
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Boise
country: United States
facility: Idaho Gastroenterology Associates
state: Idaho
city: Boise
country: United States
facility: Radiant Research Boise
state: Idaho
city: Idaho Falls
country: United States
facility: Rocky Mountain Institute of Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Rush Presbyterian St. Luke's Medical Center
state: Illinois
city: Peoria
country: United States
facility: Gastroenterology, Ltd.
state: Illinois
city: Rockford
country: United States
facility: Rockford Gastroenterology Associates, Ltd
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Hospital & Health Care Center
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Wichita
country: United States
facility: Professional Research Network of Kansas
state: Kansas
city: Louisville
country: United States
facility: Digestive Health Center, University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: Slidell
country: United States
facility: Medical Research Institute
state: Louisiana
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Center for Diabetes & Endocrinology
state: Michigan
city: Edina
country: United States
facility: Radiant Research
state: Minnesota
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Jackson
country: United States
facility: GI Associates Research
state: Mississippi
city: Omaha
country: United States
facility: University of Nebraska Health Center
state: Nebraska
city: Las Vegas
country: United States
facility: Lovelace Scientific Resources c/o Southwest Medical Associates
state: Nevada
city: Hampton
country: United States
facility: Core Health Services, Inc
state: New Hampshire
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources, Inc
state: New Mexico
city: Binghamton
country: United States
facility: Diabetic Care Associates
state: New York
city: Charlotte
country: United States
facility: Carolina Digestive Health Associates
state: North Carolina
city: Winston Salem
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Clinton
country: United States
facility: Prime Care Clinical Research
state: Oklahoma
city: Lancaster
country: United States
facility: Regional Gastroenterology Associates of Lancaster
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital-GI Section
state: Pennsylvania
city: Pittsburg
country: United States
facility: Keystone Digestive Disorders Consultants, PC
state: Pennsylvania
city: Stoneboro
country: United States
facility: Research Site
state: Pennsylvania
city: North Providence
country: United States
facility: Advanced Clinical Research, Ltd
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Orangeburg
country: United States
facility: Diabetes Control Center
state: South Carolina
city: Jackson
country: United States
facility: Regional Research Institute
state: Tennessee
city: Amarillo
country: United States
facility: Pharma Tex Research
state: Texas
city: Dallas
country: United States
facility: Radiant Research-Dallas North
state: Texas
city: San Antonio
country: United States
facility: Pro-Research Group
state: Texas
city: San Antonio
country: United States
facility: Diabetes & Glandular Disease Research Associates
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Sciences Center
state: Utah
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Kirkland
country: United States
facility: Evergreen Diabetes & Endocrinology Medical Group
state: Washington
city: Charleston
country: United States
facility: Hyperion Clinical Research
state: West Virginia
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research
state: Wisconsin
Study officials:
References: