Trial | NCT00639808  Report issue

Title

Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Diabetic Gastroparesis
Multicenter, Randomized, Double-Blind, Placebo Controlled, Crossover Single Dose Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Effect on Gastric Emptying of TZP-101 IV Infusion in Diabetic Gastroparesis Patients

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    10
The purpose of this study is to determine whether TZP-101 is safe in people with diabetes. Also to determine if TZP-101 is effective in increasing the gastric emptying rate in diabetic patients.
Study Started
Aug 31
2006
Primary Completion
Jul 31
2007
Study Completion
Mar 31
2008
Last Update
Mar 20
2008
Estimate

Drug 5% dextrose in water

60 ml IV infusion over 30 minutes

  • Other names: D5W

Drug TZP-101

1 infusion: IV 2ml/min for 30 minutes for 1 day of either 160, 320 or 600 micrograms/kg

1 Placebo Comparator

2 Experimental

TZP-101

Criteria 

Inclusion Criteria:

Subject has type 1 or type 2 diabetes mellitus
Subject has documented diagnosis of gastroparesis by:
Delayed gastric emptying (gastric retention ≥60% at 2h and ≥10% at 4 h; based on scintigraphy -4h standardized radionuclide solid meal)
A minimum 3 month history of chronic upper abdominal discomfort (two or more: chronic postprandial fullness, bloating, epigastric discomfort, early satiety, belching after meal, postprandial nausea, vomiting)
Subject has normal upper endoscopy
If female, must be permanently sterilized or postmenopausa.

Exclusion Criteria:

Patient has received any investigational drug within the preceding 30 days
Patient is taking unstable doses of medication that affects gastric motility
Patient has co-morbid condition
Patient has a positive laboratory test result for hepatitis B, hepatitis C, HIV, or controlled substances.
Patient has a history of a psychiatric disorder (including drug or alcohol addiction) requiring care by a psychiatrist or psychologist within the preceding 12 months.
Patient has a recent,adult history of clinically significanthypersensitivity reaction(s) to any drug.
Patient has known history of alcoholism
No Results Posted