Calendario›ENSC›PF614 capsule
PF614 capsule
PF614 Analgesic Activity in Acute Postoperative Pain (PF614-301)
Ensayo de Ensysce Biosciences, Inc. en Dolor postoperatorio, agudo.
- Fase
- Fase 3
- Estado
- Reclutando pacientes
- Participantes
- 320
- Centros
- 3
- Fin del objetivo primario
- ago 2026
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en dic 2025.
Qué mide
Area bajo la curva de NRS-R de dolor a traves de 48 horas (AUC4-48) (4-48 hours) (del registro, en inglés)
Qué se prueba
El ensayo evalúa la eficacia analgésica de PF614 frente a placebo para el control del dolor moderado a severo tras una cirugía de abdominoplastia.
Lo que dice el documentoTo assess the analgesic efficacy of PF614 compared to placebo in subjects with moderate to severe pain following abdominoplasty. Participants will be asked to take oral blinded doses of study medication at about one hour before surgery starts, and then every 12 hours after surgery for up to 4 days.
Traducción automática (claude-sonnet-5). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThe goal of this clinical trial is to evaluate the analgesic activity of PF614 (an oral oxycodone prodrug extended-release analgesic) for control of postsurgical pain in subjects scheduled for abdominoplasty surgery. The main question to be answered is: • To assess the analgesic efficacy of PF614 compared to placebo in subjects with moderate to severe pain following abdominoplasty. Participants will be asked to take oral blinded doses of study medication at about one hour before surgery starts, and then every 12 hours after surgery for up to 4 days. Participants will be asked to: * Rate their pain on a 0-10 numerical rating scale (NRS) at various timepoints up to 5 days following surgery; * Tell us about the need for rescue medication if they continue to have moderate-to-severe pain; * Tell us about any side effects or adverse effects that they may experience to help us understand the safety and tolerability of the test medications; * Provide periodic blood samples to help us understand how much study drug is in their system. Participants will stay in a clinic setting and be monitored for safety for 5 days following surgery. We anticipate that participants will be discharged on Day 5, pending medical review, and then keep a diary to record study-related pain and adverse effects for an additional 2-4 days after discharge.
Más ensayos de ENSC
| Ensayo | Fase | Estado | Lectura de resultados |
|---|---|---|---|
| PF614 capsule | Fase 1 | Reclutando pacientes | dic 2026 (prevista) |
| PF614 · CPT | Fase 2 | Completado | nov 2023 (real) |
| PF614 solution · MPAR-101 | Fase 1 | Completado | abr 2023 (real) |
| PF614 | Fase 1 | Completado | dic 2022 (real) |
| PF614 | Fase 1 | Completado | ago 2022 (real) |
| PF614 | Fase 1 | Completado | mar 2022 (real) |
Todos los de ENSC, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT06602271), actualizada en ene 2026.