Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Chugai Pharma USA
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Safety and Effectiveness of an Investigational Agent (GM-611) in Patients With Diabetic Gastroparesis
