Gastroparesis
Conditions
Keywords
GM-611, Diabetic gastroparesis, Bloating, Delayed gastric emptying, Mitemcinal
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.
Interventions
DRUGGM-611
Sponsors
Chugai Pharma USA
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed