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
2 other identifiers
interventional
78
6 countries
12
Brief Summary
The purpose of this study is to determine whether TZP-101 is effective in the treatment of symptomatic gastroparesis due to diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2007
Shorter than P25 for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 28, 2008
CompletedFirst Posted
Study publicly available on registry
February 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedDecember 7, 2012
December 1, 2012
1.3 years
January 28, 2008
December 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
after 4 dosing days
Secondary Outcomes (1)
Cumulative GSA score after each dosing event and after all dosing events
every 30 minutes for 4 hours
Study Arms (6)
1
PLACEBO COMPARATOR2
EXPERIMENTAL40 micrograms/kg
3
EXPERIMENTAL80 micrograms/kg
4
EXPERIMENTAL160 micrograms/kg
5
EXPERIMENTAL320 microgram/kg
6
EXPERIMENTAL600 microgram/kg
Interventions
Eligibility Criteria
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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tranzyme, Inc.lead
Study Sites (12)
California Pacific Medical Center
San Francisco, California, 94115, United States
Central Indiana Gastroenterology Group
Anderson, Indiana, 46016-4346, United States
Kansas University Medical Center
Kansas City, Kansas, 66160, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Aarhus University Hospital
Aarhus, Denmark
Amrita Institute of Medical Sciences Research Center (AIMS)
Kochi, Kerala, 682026, India
Haukeland University Hospital
Bergen, Norway
Karolinska University Hospital
Stockholm, Sweden
Manchester Royal Infirmary
Manchester, M139WL, United Kingdom
Royal Hallamshire Hospital
Sheffield, S102JF, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2008
First Posted
February 11, 2008
Study Start
October 1, 2007
Primary Completion
February 1, 2009
Study Completion
March 1, 2009
Last Updated
December 7, 2012
Record last verified: 2012-12