WHO ICTRP trial

A clinical study to study the effects of the drug TZP-101 in patients with…

CTRI/2008/091/000254 · Clinical Trials Registry India (CTRI) · Not Recruiting

Key facts

Trial ID CTRI/2008/091/000254
Public title A clinical study to study the effects of the drug TZP-101 in patients with severe gastroparesis (delayed gastric emptying)due to Diabetes Mellitus
Scientific title A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Dose-Ranging Study to Assess the Efficacy and Safety of TZP-101 when Administered as a 30 Minute I.V. Infusion to Subjects with Severe Gastroparesis due to Diabetes Mellitus
Primary sponsor Tranzyme Inc
Registry Clinical Trials Registry India (CTRI)
Recruitment status Not Recruiting
Study type Interventional
Phase Phase 2
Countries India;Denmark;Norway;Sweden;United Kingdom;United States of America
Conditions Health Condition 1: null- Severe gastroparesis due to Diabetes Mellitus
Interventions Intervention1: TZP-101: 40/80/160/320/600 micrograms/kg iv 2ml/minute for 30 minutes 1 infusion/day for 4 consecutive days Control Intervention1: Placebo - 5% dextrose in water: 60 ml IV infusion over 30 minutes
Registration date Nov 28, 2008
Target size 78
Secondary IDs NCT00612014;TZP-01-CL-G004
Registry page ctri.nic.in

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