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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 is a Phase 1 study that has completed, run by Pacira Pharmaceuticals. The registered enrollment target is 85 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04826328
The ClinicalTrials.gov registry entry for NCT04826328 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 85 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pacira Pharmaceuticals, which has 88 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT04826328 reports 0 study locations.
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.
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