Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Four placebo capsules taken orally once per day for 28 days |
|
| 10 mg TZP-102 | Experimental | One 10 mg TZP-102 Capsule and three placebo capsules taken orally once per day for 28 days |
|
| 20 mg TZP-102 | Experimental | Two 10 mg TZP-102 Capsules and two placebo capsules taken orally once per day for 28 days |
|
| 40 mg TZP-102 | Experimental | Four 10 mg TZP-102 Capsules taken orally once per day for 28 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TZP-102 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in gastric half-emptying time | study days 1 and 28 |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in gastroparesis symptoms and health-related quality of life | study days 8, 15 and 28 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach VA Medical Center | Long Beach | California | 90822 | United States | ||
| Impact Clinical Trials |
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
| 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 |
| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| D003920 | Diabetes Mellitus |
| 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 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided