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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tranzyme, Inc.
ClinicalTrials.gov Identifier:
NCT00612014
First received: January 28, 2008
Last updated: December 5, 2012
Last verified: December 2012

January 28, 2008
December 5, 2012
October 2007
February 2009   (final data collection date for primary outcome measure)
Change from baseline in the mean Gastroparesis Cardinal Symptom Index score (24 hour recall version) across the four days of dosing. Baseline is the average of the scores collected across the 4 days just prior to admission for dosing. [ Time Frame: after 4 dosing days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00612014 on ClinicalTrials.gov Archive Site
Cumulative GSA score after each dosing event and after all dosing events [ Time Frame: every 30 minutes for 4 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Severe Diabetic Gastroparesis
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

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

Subjects are randomized according to an adaptive randomization procedure.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Gastroparesis
  • Diabetes Mellitus
  • Drug: 5% dextrose in water
    60 ml IV infusion over 30 minutes
    Other Name: D5W
  • 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

  • Placebo Comparator: 1
    Intervention: Drug: 5% dextrose in water
  • Experimental: 2
    40 micrograms/kg
    Intervention: Drug: TZP-101
  • Experimental: 3
    80 micrograms/kg
    Intervention: Drug: TZP-101
  • Experimental: 4
    160 micrograms/kg
    Intervention: Drug: TZP-101
  • Experimental: 5
    320 microgram/kg
    Intervention: Drug: TZP-101
  • Experimental: 6
    600 microgram/kg
    Intervention: Drug: TZP-101
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
78
March 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Denmark,   India,   Norway,   Sweden,   United Kingdom
 
NCT00612014
TZP-101-CL-G004, 2007-003279-38
Yes
Tranzyme, Inc.
Tranzyme, Inc.
Not Provided
Not Provided
Tranzyme, Inc.
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP