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Sponsored by: |
Chugai Pharma USA |
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Information provided by: | Chugai Pharma USA |
ClinicalTrials.gov Identifier: | NCT00050882 |
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 |
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Gastroparesis |
Drug: GM-611 |
Phase II |
Study Type: | Interventional |
Study Design: | 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 |
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:
Study ID Numbers: | GM-611-05 |
Study First Received: | December 29, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00050882 History of Changes |
Health Authority: | United States: Food and Drug Administration |
GM-611 Diabetic gastroparesis Bloating Delayed gastric emptying Mitemcinal |
Paralysis Signs and Symptoms Digestive System Diseases Stomach Diseases |
Gastrointestinal Diseases Neurologic Manifestations Gastroparesis |
Paralysis Signs and Symptoms Digestive System Diseases Stomach Diseases |
Gastrointestinal Diseases Neurologic Manifestations Gastroparesis |