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NCT04826328 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety and Tolerability of FX301 in Patients Undergoing Bunionectomy
A Phase 1 study, sponsored by Pacira Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 85
- Enrollment target
NCT04826328: Completed Phase 1 study, sponsored by Pacira Pharmaceuticals.
NCT04826328 is a Phase 1 study that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 85 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04826328, a Phase 1 study, has completed, sponsored by Pacira Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 85 participants
- Enrollment target
Study Summary
This two-part study will be conducted in male and female patients 18 to 65 years of age undergoing bunionectomy. Part I - three-step, single ascending dose study design in which two drug loads (low drug load of funapide and high drug load of funapide) and two volumes (high volume and low volume) of FX301 will be explored against placebo in four cohorts of 12 patients each (9 active:3 placebo) for the management of post-surgical pain in patients undergoing bunionectomy. Part II - expansion cohort to further assess safety, tolerability, systemic exposure, and efficacy of a selected drug load/volume of FX301. An additional 36 patients will be randomized in a 1:1 ratio to receive either FX301 or placebo as a single-injection analgesic nerve block adjacent to the sciatic nerve of the popliteal fossa.
Primary Outcome
Incidence of treatment emergent adverse events after a single analgesic nerve block of FX301
Interventions
- DRUG Normal Saline
- DRUG FX301
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 85 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2022-03-30 |
| Phase | Phase 1 |
What the finished NCT04826328 record still lists
NCT04826328 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 85 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (42% higher).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT04826328 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04826328 about?
NCT04826328 is a clinical study titled "Study to Evaluate the Safety and Tolerability of FX301 in Patients Undergoing Bunionectomy". This two-part study will be conducted in male and female patients 18 to 65 years of age undergoing bunionectomy. Part I - three-step, single ascending dose study design in which two drug loads (low drug load of funapide and high drug load of funapide) and two volumes (high volume and low volume) of...
What is the current status of trial NCT04826328?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 85 participants. The study started on 2021-03-15. Estimated completion is 2022-03-30.
What interventions are being tested in trial NCT04826328?
The interventions under investigation include: Normal Saline (DRUG), FX301 (DRUG).
Who is sponsoring clinical trial NCT04826328?
This trial is sponsored by Pacira Pharmaceuticals, which has 88 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04826328's enrollment target sits among peer trials
85 656th of 2000 higher than 1,342 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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