Trials / Completed
CompletedNCT04203537
Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)
A Two-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics and Preliminary Efficacy Study of CA-008 in Patients Undergoing Total Knee Arthroplasy
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 193 (actual)
- Sponsor
- Concentric Analgesics · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Not provided
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CA-008 | Local administration during surgery |
| DRUG | Placebo | Local administration during surgery |
Timeline
- Start date
- 2019-12-04
- Primary completion
- 2020-10-26
- Completion
- 2020-10-26
- First posted
- 2019-12-18
- Last updated
- 2024-05-08
- Results posted
- 2022-01-12
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04203537. Inclusion in this directory is not an endorsement.