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NCT04203537 · ClinicalTrials.gov registry record · Phase 1
Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)
A Phase 1 study, sponsored by Concentric Analgesics.
- Completed
- Registry status
- Phase 1
- Development phase
- 193
- Enrollment target
NCT04203537: Completed Phase 1 study, sponsored by Concentric Analgesics.
NCT04203537 is a Phase 1 study that has completed, run by Concentric Analgesics. The registered enrollment target is 193 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (222% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04203537, a Phase 1 study, has completed, sponsored by Concentric Analgesics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 193 participants
- Enrollment target
Study Summary
In the pilot (Part A) of this study, multiple doses of CA-008 (vocacapsaicin) were evaluated for safety, tolerability, and PK. Doses were then selected for the expanded part (Part B) of the study, where CA-008 was compared to placebo. Patients had serial assessments of safety, PK, and drug effect.
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. AUC is calculated using the standard trapezoidal rule from serial measures of NRS taken every 4 hours from 0-96 hours following surgery and twice daily from 96h to Day 15
Interventions
- DRUG Placebo
- DRUG CA-008
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 193 participants |
| Start Date | 2019-12-04 |
| Est. Completion | 2020-10-26 |
| Phase | Phase 1 |
What the finished NCT04203537 record still lists
NCT04203537 is an interventional study that assigns participants to a tested intervention. The registered 193 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (222% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04203537 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04203537 about?
NCT04203537 is a clinical study titled "Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)". In the pilot (Part A) of this study, multiple doses of CA-008 (vocacapsaicin) were evaluated for safety, tolerability, and PK. Doses were then selected for the expanded part (Part B) of the study, where CA-008 was compared to placebo. Patients had serial assessments of safety, PK, and drug effect.
What is the current status of trial NCT04203537?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 193 participants. The study started on 2019-12-04. Estimated completion is 2020-10-26.
What interventions are being tested in trial NCT04203537?
The interventions under investigation include: Placebo (DRUG), CA-008 (DRUG).
Who is sponsoring clinical trial NCT04203537?
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 NCT04203537's enrollment target sits among peer trials
193 282nd of 2000 higher than 1,719 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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