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

Phase 2

Completed

• Conditions: Gastroparesis

• Registration Number: NCT00050882
• Lead Sponsor: Chugai Pharma USA

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-12-29
• Study First Submitted QC: 2002-12-30
• Study First Posted: 2002-12-31
• Status Verified: 2004-02
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (66)

Arizona Center for Clinical Research; 🇺🇸 Glendale, Arizona, United States

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

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