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

CA-PS-208

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.

2019-12-04

2020-10-26

2020-10-26

Completed

Early phase I

193

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Part A: dose ascending, placebo-controlled Part B: randomized, double-blind, placebo-controlled, parallel design', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 193, 'type': 'ACTUAL'}}

2024-05-08