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NCT03599089 · ClinicalTrials.gov registry record · Phase 2

Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

A Phase 2 study, sponsored by Concentric Analgesics.

Completed
Registry status
Phase 2
Development phase
147
Enrollment target

NCT03599089: Completed Phase 2 study, sponsored by Concentric Analgesics.

NCT03599089 is a Phase 2 study that has completed, run by Concentric Analgesics. The registered enrollment target is 147 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03599089, a Phase 2 study, has completed, sponsored by Concentric Analgesics.

COMPLETED
Registry status
Phase 2
Development phase
147 participants
Enrollment target

Study Summary

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating a single dose of one of three CA-008 dose levels vs. placebo injected during an elective bunionectomy Bunionectomy to assess post-surgical pain management and the need for rescue medication (oxycodone).

Primary Outcome

Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) weighted sum of pain intensity scores (at rest) from 0-10 where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. The time was collected 0 to 96 hours post-dose

Interventions

  • DRUG Placebo
  • DRUG Acetaminophen
  • DRUG Ketorolac
  • DRUG Oxycodone
  • DRUG CA-008

Trial Details

FieldValue
Enrollment Target 147 participants
Start Date 2018-07-09
Est. Completion 2018-10-23
Phase Phase 2
Concentric Analgesics

7 total trials

What the finished NCT03599089 record still lists

NCT03599089 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher).

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT03599089 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03599089 about?

NCT03599089 is a clinical study titled "Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients". This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating a single dose of one of three CA-008 dose levels vs. placebo injected during an elective bunionectomy Bunionectomy to assess post-surgical pain management and the need for rescue medicatio...

What is the current status of trial NCT03599089?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 147 participants. The study started on 2018-07-09. Estimated completion is 2018-10-23.

What interventions are being tested in trial NCT03599089?

The interventions under investigation include: Placebo (DRUG), Acetaminophen (DRUG), Ketorolac (DRUG), Oxycodone (DRUG), CA-008 (DRUG).

Who is sponsoring clinical trial NCT03599089?

This trial is sponsored by Concentric Analgesics, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03599089's enrollment target sits among peer trials

147 495th of 2000 higher than 1,505 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT03599089, the US trial registry maintained by the National Library of Medicine. NCT03599089 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.