drugset / Trial / NCT00050882
Safety and Effectiveness of an Investigational Agent (GM-611) in Patients With Diabetic Gastroparesis
Treatment
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.
Timeline
- Start
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- Primary completion
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- Completion
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MITEMCINAL | Small molecule | 5 mg | Oral |
| Subject | MITEMCINAL | Small molecule | 10 mg | Oral |