Safety and Efficacy of Once-daily Oral Administrations of TZP-102 for Gastroparesis in Patients With Diabetes Mellitus
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Evaluation of the Safety and Efficacy of Once-Daily Administrations of TZP 102 for the Treatment of Symptomatic Gastroparesis in Patients With Diabetes Mellitus
1 other identifier
interventional
92
6 countries
23
Brief Summary
The purpose of this study is to evaluate the effect of TZP-102 on gastric emptying rate, gastroparesis symptoms and health-related quality of life in diabetic patients with gastroparesis.
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 Apr 2009
Shorter than P25 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 28, 2009
CompletedFirst Posted
Study publicly available on registry
April 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedDecember 11, 2012
December 1, 2012
1 year
April 28, 2009
December 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change from baseline in gastric half-emptying time
study days 1 and 28
Secondary Outcomes (1)
change from baseline in gastroparesis symptoms and health-related quality of life
study days 8, 15 and 28
Study Arms (4)
Placebo
PLACEBO COMPARATORFour placebo capsules taken orally once per day for 28 days
10 mg TZP-102
EXPERIMENTALOne 10 mg TZP-102 Capsule and three placebo capsules taken orally once per day for 28 days
20 mg TZP-102
EXPERIMENTALTwo 10 mg TZP-102 Capsules and two placebo capsules taken orally once per day for 28 days
40 mg TZP-102
EXPERIMENTALFour 10 mg TZP-102 Capsules taken orally once per day for 28 days
Interventions
Eligibility Criteria
You may qualify if:
- to 80 years of age, inclusive.
- Type 1 or type 2 diabetes mellitus.
- Female patients of childbearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable method of contraception.
- HbA1c level less than/equal to 10.0 % at the Screening Visit.
- Diagnosis of gastroparesis including (all three of the following requirements apply): i. Documented delayed gastric emptying; ii. A greater than 3 month history of symptoms of gastroparesis; iii. A GCSI Total Score greater than/equal to 2.66 at the Screening Visit and greater than/equal to 1.90 at the Day 1 visit.
- Upper gastrointestinal obstruction ruled out by endoscopy or barium scan.
- Concomitant medications must be stable for at least 2 weeks leading up to the Baseline Visit and be maintained during the study.
- Body Mass Index (BMI) \< 35.
- Delayed gastric emptying by breath test demonstrated at the Baseline Visit.
You may not qualify if:
- Persistent daily vomiting
- Gastrectomy, obesity surgery, fundoplication, or vagotomy/pyloroplasty.
- Pyloric Botox within 6 months prior to Screening Visit.
- NG, PEG or PEJ feeding tube.
- Required in-patient hospitalization for treatment of gastroparesis within 2 weeks prior to the Screening Visit.
- Parenteral nutrition for treatment of gastroparesis within 2 months prior to the Screening Visit.
- Active gastric pacemaker within 3 months prior to the Screening Visit.
- Participation in an investigational study within 30 days prior to study entry.
- Chronic severe diarrhea.
- Diabetic ketoacidosis requiring hospitalization within 30 days prior to study entry.
- History of any eating disorder within 2 years prior to study entry.
- Significant chronic obstructive pulmonary disease or chronic asthma.
- Patient is a heavy smoker, and/or unable or unwilling to abstain from smoking during each of the three study visits during which the gastric emptying breath tests will be performed.
- History of risk factors for Torsades de Pointes.
- Patient requires treatment with certain concomitant medications known to have a clinically recognized risk for Torsades de Pointes.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tranzyme, Inc.lead
Study Sites (23)
Long Beach VA Medical Center
Long Beach, California, 90822, United States
Impact Clinical Trials
Los Angeles, California, 90036, United States
California Pacific Medical Center Research Institute
San Francisco, California, 94115, United States
University of South Florida/Tampa General Hospital
Tampa, Florida, 33606, United States
Saint John's Research Institute
Anderson, Indiana, 46012, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Univ. of Louisville Medical-Dental Complex
Louisville, Kentucky, 40202, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Texas Tech Univ. Health Sciences Center Dept. of Medicine
El Paso, Texas, 79905, United States
Aalborg Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Steno Diabetes Center
Gentofte Municipality, Denmark
Odense University Hospital
Odense, Denmark
Haukeland University Hospital
Bergen, Norway
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland
Oddzial Kliniczny Diabetologii Samodzielny Publiczny Zaklad
Lodz, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie
Warsaw, Poland
Karolinska University Hospital
Stockholm, Sweden
Ipswich Hospital NHS Trust
Ipswich, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Wellcome Truest Clinical Research Facility
Manchester, United Kingdom
MeSH Terms
Conditions
Condition 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
April 28, 2009
First Posted
April 29, 2009
Study Start
April 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
December 11, 2012
Record last verified: 2012-12