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Clinical Trial Details

Trial ID: L6146
Source ID: NCT01452815
Associated Drug: Placebo
Title: Affects of Once-daily Oral Administration of TZP-102 on the Treatment of Symptoms Associated With Diabetic Gastroparesis
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Gastroparesis|Diabetes Mellitus, Type 1|Diabetes Mellitus, Type 2
Interventions: DRUG: Placebo|DRUG: 10mg TZP-102|DRUG: 20mg TZP-102
Outcome Measures: Primary: Change from baseline in symptoms associated with diabetic gastroparesis, 12 Weeks | Secondary: Change from baseline on health-related quality of life, 12 Weeks|Adverse Events (AEs), 12 Weeks|Cardiovascular Parameters (blood pressure, heart rate, 12-Lead ECG), 12 Weeks|Clinical Chemistry and Hematology Parameters, 12 Weeks
Sponsor/Collaborators: Sponsor: Tranzyme, Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 201
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2011-09
Completion Date: 2012-11
Results First Posted:
Last Update Posted: 2013-04-25
Locations: Tranzyme Investigational Site, Huntsville, Alabama, 35801, United States|Tranzyme Investigational Site, Tucson, Arizona, 85710, United States|Tranzyme Investigational Site, Jonesboro, Arkansas, 72401, United States|Tranzyme Investigational Site, Little Rock, Arkansas, 72117, United States|Tranzyme Investigational Site, Long Beach, California, 90822, United States|Tranzyme Investigational Site, Stanford, California, 94305, United States|Tranzyme Investigational Site, Ventura, California, 93003, United States|Tranzyme Investigational Site, Hialeah, Florida, 33016, United States|Tranzyme Investigational Site, Inverness, Florida, 34450, 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, Port Orange, Florida, 32127, United States|Tranzyme Investigational Site, Oak Lawn, Illinois, 60453, United States|Tranzyme Investigational Site, Anderson, Indiana, 46016, 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, Fayetteville, North Carolina, 28304, 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, Philadelphia, Pennsylvania, 19140, United States|Tranzyme Investigational Site, Jackson, Tennessee, 38305, United States|Tranzyme Investigational Site, El Paso, Texas, 79905, United States|Tranzyme Investigational Site, Houston, Texas, 77034, United States|Tranzyme Investigational Site, Tacoma, Washington, 98405, United States|Tranzyme Investigational Site, Brugge, 8310, Belgium|Tranzyme Investigational Site, Bruxelles, 1200, Belgium|Tranzyme Investigational Site, Gent, B-9000, Belgium|Tranzyme Investigational Site, Aarhus, 8000, Denmark|Tranzyme Investigational Site, Gentofte, Denmark|Tranzyme Investigational Site, Odense, 5000, Denmark|Tranzyme Investigational Site, Porvoo, 06151, Finland|Tranzyme Investigational Site, Tampere, Finland|Tranzyme Investigational Site, Essen, 45136, Germany|Tranzyme Investigational Site, Mainz, 55116, Germany|Tranzyme Investigational Site, Stuttgart, 70191, Germany|Tranzyme Investigational Site, Bergen, 5021, Norway|Tranzyme Investigational Site, Bialystok, Poland|Tranzyme Investigational Site, Bydgoszcz, 85-094, Poland|Tranzyme Investigational Site, Kielce, 25-035, Poland|Tranzyme Investigational Site, Krakow, Poland|Tranzyme Investigational Site, Lodz, Poland|Tranzyme Investigational Site, Olsztyn, Poland|Tranzyme Investigational Site, Warszawa, 02-097, Poland|Tranzyme Investigational Site, Stockholm, Sweden|Tranzyme Investigational Site, Uppsala, Sweden
URL: https://clinicaltrials.gov/show/NCT01452815

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress