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

Completed · Phase 2

Conditions studied: Gastroparesis

In brief

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.

Key facts

Study ID

NCT00050882

Run by

Chugai Pharma USA

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Lovelace Scientific Resources — Phoenix, Arizona, United States
• AGMG Clinical Research — Anaheim, California, United States
• Orange County Clinical Research, Inc — Cypress, California, United States
• Long Beach VA Medical Center — Long Beach, California, United States
• Research Foundation of America — Los Angeles, California, United States
• Community Clinical Trials — Orange, California, United States
• The Whittier Institute for Diabetes & Endocrinology — San Diego, California, United States
• Sharp Rees-Stealy Medical Group — San Diego, California, United States
• Westlake Medical Research — Westlake Village, California, United States
• Center for Diabetes & Endocrinology — Arvada, Colorado, United States
• Barbara Davis Center for Childhood Diabetes — Denver, Colorado, United States
• Gastroenterology Associates of Manatee, PA — Bradenton, Florida, United States
• Baptist Diabetes Associates — Miami, Florida, United States
• Anchor Research Center — Naples, Florida, United States
• Suncoast Clinical Research — New Port Richey, Florida, United States
• BioQuan Research Group — North Miami, Florida, United States
• Palm Beach Research Center — West Palm Beach, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Idaho Gastroenterology Associates — Boise, Idaho, United States
• Radiant Research Boise — Boise, Idaho, United States
• Rocky Mountain Institute of Clinical Research — Idaho Falls, Idaho, United States
• Rush Presbyterian St. Luke's Medical Center — Chicago, Illinois, United States
• Gastroenterology, Ltd. — Peoria, Illinois, United States
• Rockford Gastroenterology Associates, Ltd — Rockford, Illinois, United States
• Arizona Center for Clinical Research — Glendale, Arizona, United States

Full record on ClinicalTrials.gov

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