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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03554772 | Efficacy, Tolerability, Safety, and Pharmacokinetic Study of DFN-15 | PHASE2 | COMPLETED | 120 | — | — | Jun 19, 2018 | Aug 20, 2018 | Jan 22, 2021 | 1 | United States |
The primary endpoint is the Summed Pain Intensity Difference over the first 6 hours (SPID6) after dosing compared between DFN-15 and placebo. Pain intensity (P) will be measured at timepoints of 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5 and 6, hours after baseline ,using 11-point Pain Intensity Numerical Rating Scale (NPRS). Zero (0) equals no pain and Ten (10) equals worst pain imaginable. SPID6 is created by summing the time weighted pain intensity differences (PID) scores using the area under the PID curve methodology. All SPID calculations will be performed using the standard trapezoidal rule SPIDx =∑\_(i=0)\^x▒((〖PID〗\_i+〖PID〗\_(i+1))/2) \* (T\_(i+1)- T\_i ) Where: PID\_i = P\_i - PBL (Pain score at time i and Pain score at Baseline), and (T\_i+1 - T\_i) is the Time difference in minutes between time i and time i+1. Therefore, SPID6 values may theoretically range between a maximum score of 0 ( no improvement) and a minimum score of -3525 (best improvement)
| Arm | Type | Description |
|---|---|---|
| DFN-15 (Celecoxib Oral Solution) 62.5 mg | EXPERIMENTAL | Single dose containing 62.5 mg of celecoxib in 10 ml solution |
| DFN-15 (Celecoxib Oral Solution) 125 mg | EXPERIMENTAL | Single dose containing 125 mg of celecoxib in 10 ml solution |
| DFN-15 (Celecoxib Oral Solution) 250 mg | EXPERIMENTAL | Single dose containing 250 mg of celecoxib in 10 ml solution |
| Placebo | PLACEBO_COMPARATOR | Single dose containing 0 mg of celecoxib in 10 ml solution |
| Name | Type | Description |
|---|---|---|
| DFN-15 (Celecoxib Oral Solution) 62.5 mg | DRUG | Oral Solution |
| DFN-15 (Celecoxib Oral Solution) 125 mg | DRUG | Oral Solution |
| DFN-15 (Celecoxib Oral Solution) 250 mg | DRUG | Oral Solution |
| Placebo | DRUG | Oral Solution |
Inclusion Criteria: 1. Subjects scheduled to undergo elective bilateral lower (mandibular) third molar extraction under local anesthesia. 2. Subjects must be generally healthy, ambulatory, able to understand and willing to comply with study procedures, study restrictions, assessments, and requireme...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Fresenius Medical Care AG Sponsored ADR | FMS | 2 | PHASE3 | Dialysis |
| AstraZeneca PLC | AZN | 1 | PHASE2 | AZD4144 |
| CalciMedica, Inc. | CALC | 1 | PHASE2 | Auxora |
| Talphera, Inc. | TLPH | 1 | NA | Undisclosed |
| SeaStar Medical Holding Corporation | ICU | 2 | — | Undisclosed |
| Collegium Pharmaceutical, Inc. | COLL | 1 | — | Flozin |