At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 193 enrolled
Drug / intervention
CA-008 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating CA-008 and Placebo for Postsurgical Pain. Completed, enrolled 193 participants across 4 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostsurgical Pain
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
Enrollment StartDec 2019
First PostedDec 2019
Primary CompletionOct 2020
TodayJul 2026
First PostedDec 18, 2019
Enrollment StartDec 4, 2019
Primary CompletionOct 26, 2020
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.5 years ago
Interventions
CA-008drug
Local administration during surgery
Placebodrug
Local administration during surgery