Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01637272 | Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome | PHASE2 | COMPLETED | 43 | — | — | Jan 8, 2013 | Aug 7, 2015 | May 10, 2017 | 17 | United States, Belgium +3 |
Response rate is defined as percentage of patients with no glucose values \< 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of s.c. dose escalation phase
| Arm | Type | Description |
|---|---|---|
| SOM230 | EXPERIMENTAL | Subjects with dumping syndrome treated with pasireotide |
| Name | Type | Description |
|---|---|---|
| SOM230 | DRUG | Pasireotide (SOM230) sc injection was provided as solution for injection in individual 1-point-cut 1 mL ampule, containing nominally 200 μg of pasireotide (as free base). Doses: 50, 100, 150 and 200 μg. Pasireotide im LAR depot injection was provided as micro particles powder in vials containing nominally 10, 20, 40 \& 60 mg of pasireotide (as free base) \& solvent for suspension for injection in ampules for the reconstitution of the LAR micro particles. Doses: 10, 20, 30, 40 or 60 mg |
Inclusion criteria:. * Male or female patients ≥ 18 years of age. * Post-gastric or esophageal bypass surgery, matching one of the criteria below: * Bariatric surgery: more than 6 months before signing the informed consent * Esophageal cancer surgery: were disease free at study entry * Gastric canc...