Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Postsurgical Pain

In brief

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.

Key facts

Study ID

NCT04203537

Run by

Concentric Analgesics

People needed

193

Starts

2019-12-04

Expected to finish

2020-10-26

Last updated by the study team

2024-05-08

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Lotus Clinical Reserach, LLC — Pasadena, California, United States
• Legent Orthopedic Hospital — Carrollton, Texas, United States
• First Surgical Hospital — Houston, Texas, United States
• Plano Surgical Hospital — Plano, Texas, United States

Full record on ClinicalTrials.gov

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