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NCT03307837 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of Intraoperative Administration of CA-008 for the Correction of Hallux Valgus Deformity
A Phase 1 study, sponsored by Concentric Analgesics.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT03307837: Completed Phase 1 study, sponsored by Concentric Analgesics.
NCT03307837 is a Phase 1 study that has completed, run by Concentric Analgesics. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03307837, a Phase 1 study, has completed, sponsored by Concentric Analgesics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose, sequential-group Phase 1 study. The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects. Within each dose cohort, 6 subjects will be randomized to active, and 2 will be randomized to placebo.
Primary Outcome
Assessment of skin reactions to determine if any change from 24 to 48 hours.
Interventions
- DRUG Placebo
- DRUG CA-008
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-11-02 |
| Est. Completion | 2018-04-25 |
| Phase | Phase 1 |
What the finished NCT03307837 record still lists
NCT03307837 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03307837 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03307837 about?
NCT03307837 is a clinical study titled "A Phase 1 Study of Intraoperative Administration of CA-008 for the Correction of Hallux Valgus Deformity". This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose, sequential-group Phase 1 study. The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects. Within each dose cohort, 6 subjects will be randomized to active, and 2 will be r...
What is the current status of trial NCT03307837?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2017-11-02. Estimated completion is 2018-04-25.
What interventions are being tested in trial NCT03307837?
The interventions under investigation include: Placebo (DRUG), CA-008 (DRUG).
Who is sponsoring clinical trial NCT03307837?
This trial is sponsored by Concentric Analgesics, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03307837's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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