Phase 2 Completed N=34 Randomized Quadruple-blind Treatment

Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair

Postsurgical Pain

Source: ClinicalTrials.gov NCT04774328 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2022

Primary outcomePrimary: Pain at Rest - Part B — 148.98; 188.26 score on a scale*hours — p=0.4812

Summary

A Three-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics, and Preliminary Efficacy Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain at Rest - Part B	148.98; 188.26	0.4812
SECONDARY Evoked NRS - Part B	187.58; 345.66; 116.24; 171.28; 143.42; 222.14	0.0222 sig
SECONDARY Opioid Consumption - Part B	27.18; 36.56; 29.68; 37.81	0.4690

Eligibility Criteria

Inclusion Criteria

Scheduled elective, primary, open laparotomy with VHR, with retromuscular, preperitoneal mesh placement, with midline fascial reconstruction
ASA physical class 1, 2, or 3
BMI </= 40 kg/m2
Aged 18-80 years old

Exclusion Criteria

Concurrent condition requiring analgesic treatment during study period
Opioid tolerant
Known allergy to capsaicin or other study medication
Use of prohibited medications

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Data sourced from ClinicalTrials.gov (NCT04774328). 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.