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

PHASE2CompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

October 31, 2007

Primary Completion Date

February 28, 2009

Study Completion Date

March 31, 2009

Conditions
GastroparesisDiabetes Mellitus
Interventions
DRUG

5% dextrose in water

60 ml IV infusion over 30 minutes

DRUG

TZP-101

"40 micrograms/kg iv 2ml/minute for 30 minutes~1 infusion/day for 4 consecutive days"

DRUG

TZP-101

"80 micrograms/kg iv 2ml/minute for 30 minutes~1 infusion/day for 4 consecutive days"

DRUG

TZP-101

"160 micrograms/kg iv 2ml/minute for 30 minutes~1 infusion/day for 4 consecutive days"

DRUG

TZP-101

"320 micrograms/kg iv 2ml/minute for 30 minutes~1 infusion/day for 4 consecutive days"

DRUG

TZP-101

"600 micrograms/kg iv 2ml/minute for 30 minutes~1 infusion/day for 4 consecutive days"

Trial Locations (12)

27157

Wake Forest University Health Sciences, Winston-Salem

40202

University of Louisville, Louisville

66160

Kansas University Medical Center, Kansas City

94115

California Pacific Medical Center, San Francisco

682026

Amrita Institute of Medical Sciences Research Center (AIMS), Kochi

46016-4346

Central Indiana Gastroenterology Group, Anderson

02114

Massachusetts General Hospital, Boston

Unknown

Aarhus University Hospital, Aarhus

Haukeland University Hospital, Bergen

Karolinska University Hospital, Stockholm

M139WL

Manchester Royal Infirmary, Manchester

S102JF

Royal Hallamshire Hospital, Sheffield

All Listed Sponsors
lead

Tranzyme, Inc.

INDUSTRY

NCT00612014 - Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Severe Diabetic Gastroparesis | Biotech Hunter | Biotech Hunter