Safety and Effectiveness of an Investigational Agent (GM-611) in Patients With Diabetic Gastroparesis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00050882|
Recruitment Status : Completed
First Posted : December 31, 2002
Last Update Posted : June 24, 2005
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastroparesis||Drug: GM-611||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00050882