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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04826328 | Study to Evaluate the Safety and Tolerability of FX301 in Patients Undergoing Bunionectomy | PHASE1 | COMPLETED | 85 | — | — | Mar 15, 2021 | Mar 30, 2022 | Aug 26, 2022 | 1 | United States |
Incidence of treatment emergent adverse events after a single analgesic nerve block of FX301
| Arm | Type | Description |
|---|---|---|
| FX301 Low Dose Low Volume | EXPERIMENTAL | 65 mg of funapide given as a single injection nerve block adjacent to the sciatic nerve of the popliteal fossa |
| FX301 Low Dose High Volume | EXPERIMENTAL | 130 mg of funapide given as a single injection nerve block adjacent to the sciatic nerve of the popliteal fossa |
| FX301 High Dose Low Volume | EXPERIMENTAL | 130 mg of funapide given as a single injection nerve block adjacent to the sciatic nerve of the popliteal fossa |
| FX301 High Dose High Volume | EXPERIMENTAL | 260 mg of funapide given as a single injection nerve block adjacent to the sciatic nerve of the popliteal fossa |
| Normal Saline | PLACEBO_COMPARATOR | Low or high matching volume of preservative-free normal saline given as a single injection adjacent to the sciatic nerve of the popliteal fossa |
| Name | Type | Description |
|---|---|---|
| FX301 | DRUG | FX301 is an extended-release formulation of funapide being developed as a single injection peripheral nerve block for the management of acute postsurgical pain |
| Normal Saline | DRUG | Single peripheral nerve injection |
Inclusion Criteria: 1. Written consent to participate in the study 2. Be willing and able to complete study procedures and pain scales, follow instructions and communicate meaningfully in English with study personnel, and return for outpatient follow-up visits as required. 3. Male or female ≥18 to ...