Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Severe Diabetic Gastroparesis

Completed · Phase 2

Conditions studied: Gastroparesis, Diabetes Mellitus

In brief

The purpose of this study is to determine whether TZP-101 is effective in the treatment of symptomatic gastroparesis due to diabetes.

Key facts

Study ID: NCT00612014
Run by: Tranzyme, Inc.
People needed: 78
Starts: 2007-10-01
Expected to finish: 2009-03-01
Last updated by the study team: 2012-12-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject has type 1 or type 2 diabetes mellitus
Subject has documented diagnosis of gastroparesis (all of the following apply):
Confirmed delayed gastric emptying (see Appendix IV; properly conducted gastric emptying assessments within last 6 months acceptable)
AND a minimum 3 month history of relevant symptoms for gastroparesis (chronic postprandial fullness, bloating, epigastric discomfort, early satiety, belching after meal, postprandial nausea, vomiting).
AND a mean Gastroparesis Cardinal Symptom Index (GCSI) Score (2 week recall version) of ≥ 2.66
AND it is confirmed by endoscope that there are no obstructive lesions in the esophagus or stomach (endoscopy within prior 3 months acceptable)
Subject has never had a gastrectomy, nor major abdominal surgery or any evidence of bowel obstruction within the previous 12 months
Dosage of any concomitant medications has been stable for at least 3 weeks
HbA1c level is ≤ 10.0%
Subject has a BMI < 30
Subject body weight is ≤ 100 kg
If female, post-menopausal for the past 12 months, surgically sterile (i.e. tubal ligation, hysterectomy), or using an adequate method of birth control (i.e., oral contraceptives, double barrier method, IUD cover) or sterilized partner

You may not qualify if…

Subject has acute severe gastroenteritis
Subject has a gastric pacemaker
Subject is on chronic parenteral feeding
Subject has daily persistent severe vomiting
Subject has pronounced dehydration
Subject has had diabetic ketoacidosis in last 4 weeks
Subject has a history of eating disorders (anorexia nervosa, binge eating, bulimia)
Subject has a marked baseline prolongation of QT/QTc interval (repeated demonstration of a QTc interval >450 ms for male / >470 ms for female)
Subject has a history of additional risk factors for Torsades de Pointes (heart failure, chronic hypokalemia, family history of Long QT Syndrome)
Subject requires use of concomitant medication that prolongs the QT interval
List provided to clinical sites
Subject has history of cardiovascular ischemia in previous 12 months or acute myocardial infarction (MI) or unstable angina
Subject requires use of concomitant medication that is known to interact with isoenzyme CYP3A4 and the combination with an CYP3A4 inhibitor is known to introduce a clinically significant drug interaction
List provided to clinical sites
Subject has a history of psychiatric disorder or cognitive impairment that would interfere with participation in the study
Subject has a history of alcoholism
Subject is taking regular daily narcotics
Subject has a known history of Hep B, Hep C or HIV
Subject has severely impaired renal function (creatinine clearance < 30 mL/min)
Subject has severe impairment of liver function, defined as albumin level ≤ 2.5 gm/dL and/or prothrombin time >6 seconds over control (INR > 2.3)
Subject has participated in an investigational study within 30 days prior to or received TZP-101 within 90 days prior to study initiation
Subject is pregnant or is breast-feeding

Where it is running

California Pacific Medical Center — San Francisco, California, United States
Central Indiana Gastroenterology Group — Anderson, Indiana, United States
Kansas University Medical Center — Kansas City, Kansas, United States
University of Louisville — Louisville, Kentucky, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
Aarhus University Hospital — Aarhus, Denmark
Amrita Institute of Medical Sciences Research Center (AIMS) — Kochi, Kerala, India
Haukeland University Hospital — Bergen, Norway
Karolinska University Hospital — Stockholm, Sweden
Manchester Royal Infirmary — Manchester, United Kingdom
Royal Hallamshire Hospital — Sheffield, United Kingdom

Full record on ClinicalTrials.gov

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