Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SP-304 · 1 trial · 1 indication
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...
SP-304 is being studied for the treatment of chronic idiopathic constipation, a gastrointestinal condition in which patients experience persistent constipation without an identifiable cause. It is a small molecule therapeutic candidate developed by Bausch Health Companies Inc. and has been evaluated in a Phase 2 clinical trial in adults with this condition.
SP-304 is developed by Bausch Health Companies Inc., which trades on the New York Stock Exchange under the ticker symbol BHC. The company is responsible for the clinical development of the drug candidate for chronic idiopathic constipation.
SP-304 is in Phase 2 clinical development. It has completed one Phase 2 trial, a dose ranging study in patients with chronic idiopathic constipation. There are currently no active trials listed for SP-304, and it is not approved by the FDA for any indication.
SP-304 has been evaluated in a single completed Phase 2 clinical trial, NCT01053962, titled "SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation." The trial enrolled 84 participants in the United States, was randomized, double-blind, and placebo-controlled, and included adults 18 years and older.