Phase 2
Completed N=193
Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)
Postsurgical Pain
Source: ClinicalTrials.gov NCT04203537 ↗
Enrolled (actual)
193
Serious AEs
2.6%
Results posted
Jan 2022
Primary outcomePrimary: Pain Intensity Scores — 367.41; 415.27; 373.92; 447.05 scores on a scale*hours — p=0.0004
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Intensity Scores |
367.41; 415.27; 373.92; 447.05; 397.68; 448.02 | 0.0004 sig |
| SECONDARY Total Opioid Consumption |
141.37; 165.92; 151.04; 206.26; 154.795; 183.74 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Scheduled elective Total Knee Arthroplasty (TKA) under spinal anesthesia
- Aged 18-80 years old
- ASA physical class 1, 2, or 3
- BMI </= 42 kg/m2
- Generally healthy
Exclusion Criteria
- Concurrent condition requiring analgesic treatment during study period
- Opioid tolerant
- Known allergy to capsaicin or other study medication
- Use of prohibited medications
Data sourced from ClinicalTrials.gov (NCT04203537). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.