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The purpose of this study is to test the safety and effectiveness of two dosage levels (10mg and 20mg) of TZP-102 compared to placebo (capsule that looks like the study drug but contains no active drug), administered once-daily for 12 weeks, in diabetic subjects with symptoms associated with gastroparesis.
Considered subjects will be screened to determine eligibility for entry into the study. The Screening Visit must take place at least 14 days, but not more than 21 days, before the planned date of study entry (randomization and administration of the first dose of study drug on Study Day 1). The baseline evaluation of gastric emptying must be scheduled at least 7 days (in the U.S.) and 10 days (in Europe) before the Day 1 Visit. Subjects will answer questions relating to their gastroparesis symptoms in an electronic diary (like a palm pilot) beginning on the first day of the screening period.
Eligible subjects will be randomized to receive placebo or one of two dosages of TZP-102 (10mg or 20mg) once daily for 12 weeks. After randomization and administration of the first dose of study drug on Study Day 1 (the Study Entry Visit), subsequent visits to the clinic will be scheduled every two weeks during the 12-week Treatment period and 4-week Follow-Up Period.
All visits will be conducted on an outpatient basis. Visits for a given subject throughout the study should be scheduled to start at approximately the same time, in the morning. Subjects will be instructed to take their daily dose of study drug each morning (when not attending a study visit), at least 30 minutes before breakfast. Subjects will be instructed to not take study drug on the morning of each treatment period visit and to bring study drug supplies with them to the clinic; study drug will be administered in the clinic after all scheduled assessments/procedures (after all pre-dose assessments at each of the Day 1 and Week 12 Visits) are completed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Drug: placebo |
|
| 2 | Experimental | 10mg TZP-102 |
|
| 3 | Experimental | 20mg TZP-102 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Two #2 oval shaped,opaque-white, hard gelatin shell capsules containing inactive ingredients taken orally once daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in symptoms associated with diabetic gastroparesis | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Connie Cosentino | Tranzyme Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tranzyme Investigational Site | Huntsville | Alabama | 35801 | United States | ||
| Tranzyme Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23848826 | Derived | 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. |
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| 10mg TZP-102 | Drug | One 10mg #2 oval shaped, opaque-white, hard gelatin shell capsule containing active ingredients and one placebo capsule each taken orally once daily for 12 Weeks |
|
| 20mg TZP-102 | Drug | Two 10mg #2 oval shaped, opaque-white, hard gelatin shell capsules containing active ingredients |
|
| 12 Weeks |
| Clinical Chemistry and Hematology Parameters | 12 Weeks |
| 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 | Bruges | 8310 | Belgium |
| Tranzyme Investigational Site | Brussels | 1200 | Belgium |
| Tranzyme Investigational Site | Ghent | B-9000 | Belgium |
| Tranzyme Investigational Site | Aarhus | 8000 | Denmark |
| Tranzyme Investigational Site | Gentofte Municipality | 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 | Warsaw | 02-097 | Poland |
| Tranzyme Investigational Site | Stockholm | Sweden |
| Tranzyme Investigational Site | Uppsala | Sweden |
| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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