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NCT06629402: CPT
Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201)
Phase 2 trial testing PF614 in Acute Pain in 16 participants. Completed in 15 November 2023.
14 November 2023
Quick facts
| Lead sponsor | Ensysce Biosciences |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 5 October 2023 |
| Primary completion | 14 November 2023 |
| Estimated completion | 15 November 2023 |
| Sites | 1 location across United States |
Drugs / interventions tested
- PF614 — full drug profile →
- Placebo
Conditions studied
- Acute Pain — all drugs for Acute Pain →
Sponsor
Ensysce Biosciences — full company profile →
Who can join
Adults 18 to 55, male only, with Acute Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The primary objective of the study is to evaluate the onset of analgesia following administration of a single oral dose of PF614 (50 mg or 100 mg) or placebo in healthy male subjects in an experimental pain model (cold pressor test \[CPT\]).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06629402
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PF614
Trials testing the same drug.
- NCT05571345 — A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-104) · Phase 1 · completed
- NCT05567354 — A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-103) · Phase 1 · completed
- NCT05043766 — Evaluation of Oral PF614 Relative to OxyContin (PF614-102) · Phase 1 · completed
- NCT02454712 — Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101) · Phase 1 · completed
Other recruiting trials for Acute Pain
Currently open trials in the same condition.
- NCT06779604 — Dexmedetomidine and Dexamethasone Added as Adjuvant Infraclavicular Brachial Plexus Block in Upper Limb Surgery · recruiting
- NCT07348419 — Quadro-Iliac vs Thoracolumbar Interfascial Plane Block for Analgesia After Single-Level Lumbar Disc Surgery · NA · recruiting
- NCT07335159 — Does Patient Testimonial Improve the Pain Relief Derived From a Brief Intervention · NA · recruiting
- NCT07348523 — Comparison of the Postoperative Analgesic Efficacy of Classical and Modified Erector Spinae Plane Blocks After Lumbar Sp · NA · recruiting
- NCT07336264 — Characterization of Acute Pain · recruiting
Other Ensysce Biosciences trials
Trials by the same sponsor.
- NCT06500793 — Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102) · Phase 1 · recruiting
- NCT05571345 — A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-104) · Phase 1 · completed
- NCT05567354 — A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-103) · Phase 1 · completed
- NCT05090280 — Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101) · Phase 1 · completed
- NCT05043766 — Evaluation of Oral PF614 Relative to OxyContin (PF614-102) · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06629402 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ensysce Biosciences
- Last refreshed: 8 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06629402.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing