Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050882
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2002-12-29
Brief Title:
Safety and Effectiveness of an Investigational Agent GM-611 in Patients With Diabetic Gastroparesis
Sponsor:
Chugai Pharma USA
Organization:
Chugai Pharma USA
Study Overview
Official Title:
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
Status Verified Date:
2004-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None