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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01053962 | SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation | PHASE2 | COMPLETED | 84 | — | — | Mar 1, 2010 | Aug 1, 2010 | Jan 2, 2020 | 14 | United States |
Incidences of adverse events from Baseline through the end of the Follow-up period.
| Arm | Type | Description |
|---|---|---|
| SP-304 0.3 mg | EXPERIMENTAL | SP-304 0.3 mg tablet by mouth once daily for 14 consecutive days. |
| SP-304 1.0 mg | EXPERIMENTAL | SP-304 1.0 mg tablet by mouth once daily for 14 consecutive days. |
| SP-304 3.0 mg | EXPERIMENTAL | SP-304 3.0 mg tablet by mouth once daily for 14 consecutive days |
| SP-304 9.0 mg | EXPERIMENTAL | SP-304 9.0 mg tablet by mouth once daily for 14 consecutive days. |
| Placebo | PLACEBO_COMPARATOR | Placebo tablet by mouth once daily for 14 consecutive days |
| Name | Type | Description |
|---|---|---|
| SP-304 0.3 mg | DRUG | SP-304 0.3 mg |
| SP-304 1.0 mg | DRUG | SP-304 1.0 mg |
| SP-304 3.0 mg | DRUG | SP-304 3.0 mg |
| SP-304 9.0 mg | DRUG | SP-304 9.0 mg |
| Placebo | DRUG | Placebo |
Inclusion Criteria: * Subject is able to understand and willing to sign the Informed Consent Form (ICF) and capable of providing written authorization for use and disclosure of protected health information per requirements of 45 CFR 164.508 (Health Insurance Portability and Accountability Act \[HIP...