Trials / Completed
CompletedNCT00050882
Safety and Effectiveness of an Investigational Agent (GM-611) in Patients With Diabetic Gastroparesis
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Chugai Pharma USA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GM-611 |
Timeline
- First posted
- 2002-12-31
- Last updated
- 2005-06-24
Locations
67 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00050882. Inclusion in this directory is not an endorsement.