Study Stopped
Insufficient efficacy in planned interim futility analysis
Diabetic Gastroparesis Efficacy/Safety Study of TZP-102
DIGEST
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Evaluation of the Efficacy and Safety of TZP-102 Given Orally Three Times a Day for the Treatment of Symptoms Associated With Diabetic Gastroparesis
1 other identifier
interventional
120
2 countries
35
Brief Summary
The purpose of this study is to test the safety and effectiveness of 10 mg TZP-102 given prior to meals three times a day compared to placebo (capsule that looks like active study drug but contains no active drug), administered for 12 weeks, in diabetic subjects with symptoms associated 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 Aug 2012
Shorter than P25 for phase_2
35 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
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 10, 2012
CompletedFirst Posted
Study publicly available on registry
August 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedDecember 20, 2012
December 1, 2012
5 months
August 10, 2012
December 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in symptoms associated with diabetic gastroparesis
12 Weeks
Secondary Outcomes (2)
Change from baseline in health-related quality of life
12 Weeks
Adverse events (AEs), vital signs, ECGs, clinical laboratory parameters
12 Weeks
Study Arms (2)
TZP-102 three times a day
EXPERIMENTAL10 mg TZP-102 will be taken 30 minutes prior to each main meal for a total of three daily doses.
Placebo three times a day
PLACEBO COMPARATORPlacebo will be taken 30 minutes prior to each main meal for a total of three daily doses.
Interventions
One oval-shaped, opaque-white, hard gelatin capsule containing active ingredient will be taken orally three times a day for 12 weeks
One oval-shaped, opaque-white, hard gelatin capsule of placebo indistinguishable from active drug will be taken orally three times a day for 12 weeks
Eligibility Criteria
You may qualify if:
- to 80 years of age inclusive
- Type 1 or type 2 diabetes mellitus
- History of symptoms of gastroparesis for at least 3 months leading up to the Screening Visit
- Documented delayed gastric emptying
- Upper gastrointestinal obstruction ruled out by endoscopy or barium scan
- Concomitant medications must be stable for at least 2 weeks leading up to the Screening visit and must be maintained during the study.
- Females of child-bearing potential must have a negative serum pregnancy test and use (and agree to continue to use throughout the study) an acceptable form of contraception
You may not qualify if:
- Gastrectomy, bariatric surgery, fundoplication or vagotomy/pyloroplasty
- Has had or plans to have endoscopic pyloric injections of botulinum toxin within 6 months prior to the Screening Visit or during the study
- NG, PEG or PEJ feeding tube or inpatient hospitalization for gastroparesis within 2 weeks prior to the Screening Visit
- Required 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tranzyme, Inc.lead
Study Sites (35)
Tranzyme Investigational Site
Huntsville, Alabama, 35801, United States
Tranzyme Investigational Site
Tucson, Arizona, 85710, United States
Tranzyme Investigational Site
North Little Rock, Arkansas, 72117, United States
Tranzyme Investigational Site
Long Beach, California, 90822, United States
Tranzyme Investigational Site
Ventura, California, 93003, United States
Tranzyme Investigational Site
Hialeah, Florida, 33016, United States
Tranzyme Investigational Site
Inverness, Florida, 34452, United States
Tranzyme Investigational Site
Jacksonville, Florida, 32256, United States
Tranzyme Investigational Site
Miami, Florida, 33144, United States
Tranzyme Investigational Site
Miami, Florida, 33183, United States
Tranzyme Investigational Site
New Smyrna Beach, Florida, 32168, United States
Tranzyme Investigational Site
Anderson, Indiana, 46106, United States
Tranzyme Investigational Site
Indianapolis, Indiana, 46202, United States
Tranzyme Investigational Site
Kansas City, Kansas, 66160, United States
Tranzyme Investigational Site
Monroe, Louisiana, 71201, United States
Tranzyme Investigational Site
Boston, Massachusetts, 02215, United States
Tranzyme Investigational Site
Mexico, Missouri, 65265, United States
Tranzyme Investigational Site
Raleigh, North Carolina, 27612, United States
Tranzyme Investigational Site
Salisbury, North Carolina, 28144, United States
Tranzyme Investigational Site
Winston-Salem, North Carolina, 27103, United States
Tranzyme Investigational Site
Oklahoma City, Oklahoma, 73104, United States
Tranzyme Investigational Site
Portland, Oregon, 97210, United States
Tranzyme Investigational Site
El Paso, Texas, 79905, United States
Tranzyme Investigational Site
Bialystok, 15732, Poland
Tranzyme Investigational Site
Bialystok, 15950, Poland
Tranzyme Investigational Site
Bydgoszcz, 85094, Poland
Tranzyme Investigational Site
Kielce, 25035, Poland
Tranzyme Investigational Site
Krakow, 31530, Poland
Tranzyme Investigational Site
Lodz, 90251, Poland
Tranzyme Investigational Site
Lublin, 20090, Poland
Tranzyme Investigational Site
Lublin, 20607, Poland
Tranzyme Investigational Site
Olsztyn, 10561, Poland
Tranzyme Investigational Site
Rzeszów, 35073, Poland
Tranzyme Investigational Site
Warsaw, 02097, Poland
Tranzyme Investigational Site
Zgierz, 95100, Poland
Related Publications (1)
McCallum RW, Lembo A, Esfandyari T, Bhandari BR, Ejskjaer N, Cosentino C, Helton N, Mondou E, Quinn J, Rousseau F; TZP-102 Phase 2b Study Group. Phase 2b, randomized, double-blind 12-week studies of TZP-102, a ghrelin receptor agonist for diabetic gastroparesis. Neurogastroenterol Motil. 2013 Nov;25(11):e705-17. doi: 10.1111/nmo.12184. Epub 2013 Jul 15.
PMID: 23848826DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elsa Mondou, M.D.
Tranzyme, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2012
First Posted
August 14, 2012
Study Start
August 1, 2012
Primary Completion
January 1, 2013
Study Completion
February 1, 2013
Last Updated
December 20, 2012
Record last verified: 2012-12