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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00878462 | An Acceptability Study of Unflavored Asenapine Versus Raspberry Flavored Asenapine in Stable Patients With a Psychotic Disorder (P07010)(COMPLETED) | PHASE2 | COMPLETED | 174 | — | — | Jun 29, 2005 | Oct 15, 2005 | Aug 15, 2024 | - | — |
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | EXPERIMENTAL | Subjects randomly assigned to this sequence receive in order: Treatment A, C, B, A, C, B. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
| Sequence 2 | EXPERIMENTAL | Subjects randomly assigned to this sequence receive in order: Treatment A, B, C, A, B, C. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
| Sequence 3 | EXPERIMENTAL | Subjects randomly assigned to this sequence receive in order: Treatment B, C, A, B, C, A. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
| Sequence 4 | EXPERIMENTAL | Subjects randomly assigned to this sequence receive in order: Treatment B, A, C, B, A, C. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
| Sequence 5 | EXPERIMENTAL | Subjects randomly assigned to this sequence receive in order: Treatment C, B, A, C, B, A. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
| Sequence 6 | EXPERIMENTAL | Subjects randomly assigned to this sequence receive in order: Treatment C, A, B, C, A, B. Each treatment was one dose, and each patient received a dose in the morning and evening for 3 consecutive days. |
| Name | Type | Description |
|---|---|---|
| Asenapine WHITE raspberry flavor (Treatment A) | DRUG | Asenapine (Org 5222), 5 mg white raspberry flavored as fast dissolving tablets |
| Asenapine RED raspberry flavor (Treatment B) | DRUG | Asenapine (Org 5222), 5 mg red raspberry flavored as fast dissolving tablets |
| Asenapine WHITE UNFLAVORED (Treatment C) | DRUG | Asenapine (Org 5222), 5 mg WHITE UNflavored as fast dissolving tablets |
Inclusion Criteria: * are at least 18 years of age and of legal minimum age for trial participation; * are a male, or a female who is not of childbearing potential * are free from an acute exacerbation of psychosis for at least 3 months; * have a current DSM-IV diagnosis of schizophrenia (paranoid,...