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| Sponsor: | Chugai Pharma USA |
|---|---|
| Information provided by: | Chugai Pharma USA |
| ClinicalTrials.gov Identifier: | NCT00050882 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Gastroparesis |
Drug: GM-611 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Major Inclusion Criteria – Others Stipulated within the Protocol
The study physician must assure you have/are:
Exclusion Criteria:
Major Exclusion Criteria – Others Stipulated within the Protocol
The study physician must assure you do not have/are not:
Contacts and Locations
Show 67 Study Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00050882 History of Changes |
| Other Study ID Numbers: | GM-611-05 |
| Study First Received: | December 29, 2002 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
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GM-611 Diabetic gastroparesis Bloating Delayed gastric emptying Mitemcinal |
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Gastroparesis Stomach Diseases Gastrointestinal Diseases Digestive System Diseases |
Paralysis Neurologic Manifestations Signs and Symptoms |