Safety and Effectiveness of an Investigational Agent (GM-611) in Patients With Diabetic Gastroparesis - Tabular View

Tracking Information
First Received Date ^ICMJE	December 29, 2002
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00050882 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Effectiveness of an Investigational Agent (GM-611) in Patients With Diabetic Gastroparesis
Official Title ^ICMJE	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
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment
Condition ^ICMJE	Gastroparesis
Intervention ^ICMJE	Drug: GM-611
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Major Inclusion Criteria – Others Stipulated within the Protocol The study physician must assure you have/are: Must be at least 18 years of age and have diabetes mellitus requiring insulin, which may be in addition to oral anti-diabetic agents. At least a three month history of the symptoms of gastroparesis that may include: early satiety (feeling full soon after beginning a meal), persistent fullness (long after eating), abdominal distention or bloating, nausea and vomiting. - No evidence of mechanical gastric obstruction, or other gastric problems since the onset of gastroparesis symptoms. You may be required to under go a Gastric Emptying Test (GET) procedure. You must be willing and able to maintain a daily telephone diary and consent to participate in this study. Exclusion Criteria: Major Exclusion Criteria – Others Stipulated within the Protocol The study physician must assure you do not have/are not: Prior history of gastric surgery, excluding reflux surgery. Inability to withdraw from current prokinetic agents (e.g., metoclopramide, erythromycin, others) prior to, and during the study. Unstable current medical or surgical condition, or a recent history of frequent hospitalizations. A history of: HIV, recurring infection affecting the gastrointestinal track, cirrhosis, acute or chronic liver disease, active pancreatitis, cholecystitis, psychosis, severe depression, Parkinson’s disease, myopathy, scleroderma, eating disorder, or organ transplant. Evidence or history of QT-prolongation, or use of drugs that are, or may be associated with QT-prolongation are prohibited. May not be pregnant, breast-feeding or not using approved methods of contraception. An allergy or intolerance to macrolide antibiotics (e.g., erythromycin). Use of any investigational drug within 30 days prior to screening.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00050882
Responsible Party
Study ID Numbers ^ICMJE	GM-611-05
Study Sponsor ^ICMJE	Chugai Pharma USA
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Chugai Pharma USA
Verification Date	February 2004
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP