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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 is a Phase 1 study that has completed, run by Concentric Analgesics. The registered enrollment target is 40 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG CA-008

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2017-11-02
Est. Completion 2018-04-25
Phase Phase 1

Sponsor

Concentric Analgesics

7 total trials

What the Registry Record Tells You About NCT03307837

The ClinicalTrials.gov registry entry for NCT03307837 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Concentric Analgesics, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03307837 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.