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

Gastroparesis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00050882
• Other study ID #: GM-611-05
• Status: Completed
• Phase: Phase 2
• First received: December 29, 2002
• Last updated: June 23, 2005

Study information

• Verified date: February 2004
• Source: Chugai Pharma USA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Drug:
• GM-611

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharma USA

Country where clinical trial is conducted

United States,