8 completed, 1 terminated. 5 Phase 2, 2 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Completed 4, Terminated 1 |
| Phase 3 | 2 | Completed 2 |
| Phase 1 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Diabetic Gastroparesis Efficacy/Safety Study of TZP-102 10 mg TZP-102, Placebo - Diabetic Gastroparesis | Phase 2 | Terminated | Tranzyme, Inc. | 120 | 2012-08-01 | 2012-12-20 |
| Affects of Once-daily Oral Administration of TZP-102 on the Treatment of Symptoms Associated With Diabetic Gastroparesis Placebo, 10mg TZP-102, 20mg TZP-102 - Gastroparesis, Diabetes Mellitus, Type 1 | Phase 2 | Completed | Tranzyme, Inc. | 201 | 2011-09-01 | 2013-04-25 |
| Patient Understanding (Cognitive Debriefing) of a Daily Diary of Gastroparesis Symptoms Diabetes Mellitus, Gastroparesis | Completed | Tranzyme, Inc. | 40 | 2011-03-01 | 2011-05-24 | |
| Ulimorelin Study of Efficacy and Safety (ULISES 008) Ulimorelin Intravenously (IV), Ulimorelin Invtravenously (IV), 5% dextrose in water - Gastrointestinal Dysmotility | Phase 3 | Completed | Tranzyme, Inc. | 330 | 2011-02-01 | 2012-07-26 |
| Ulimorelin Study of Efficacy and Safety (ULISES 007) Ulimorelin Intravenously (IV), 5% dextrose in water - Gastrointestinal Dysmotility | Phase 3 | Completed | Tranzyme, Inc. | 332 | 2011-01-01 | 2012-07-26 |
| Safety and Efficacy of Once-daily Oral Administrations of TZP-102 for Gastroparesis in Patients With Diabetes Mellitus TZP-102, Placebo - Gastroparesis, Diabetes Mellitus | Phase 2 | Completed | Tranzyme, Inc. | 92 | 2009-04-01 | 2012-12-11 |
| Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Severe Diabetic Gastroparesis 5% dextrose in water, TZP-101 - Gastroparesis, Diabetes Mellitus | Phase 2 | Completed | Tranzyme, Inc. | 78 | 2007-10-01 | 2012-12-07 |
| Safety and Efficacy of IV Infusion of TZP-101 for POI After Major Open Abdominal Surgery 5% dextrose in water, TZP-101 - Postoperative Ileus | Phase 2 | Completed | Tranzyme, Inc. | 267 | 2007-07-01 | 2012-12-07 |
| Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Diabetic Gastroparesis 5% dextrose in water, TZP-101 - Gastroparesis, Diabetes Mellitus | Phase 1 | Completed | Tranzyme, Inc. | 10 | 2006-08-01 | 2008-03-20 |
Gastroparesis (6) · Diabetes Mellitus (4) · Diabetes Mellitus, Type 1 (2) · Diabetes Mellitus, Type 2 (2)
Glucose (5) · Water (5) · ulimorelin (3)
United States (8) · Denmark (4) · Poland (4) · Sweden (4) · Norway (3) · Romania (3) · United Kingdom (3) · India (2) · Belgium (1) · Bulgaria (1) · Czechia (1) · Finland (1) · France (1) · Germany (1) · Hungary (1)
Connie Cosentino (1) · Elsa Mondou, M.D. (1) · Henry Parkman, MD (1) · Irene Sarosiek, MD (1) · Kenneth Koch, MD (1) · Tuba Esfandyari, MD (1)