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

Phase 1

Completed

• Conditions: Postsurgical Pain
• Interventions: Drug: CA-008; Drug: Placebo

• Registration Number: NCT04203537
• Lead Sponsor: Concentric Analgesics

Brief 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.

Detailed Description

Not provided

Study Timeline

• Study Start: 2019-12-04
• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-18
• Primary Completion: 2020-10-26
• Study Completion: 2020-10-26
• Results First Submitted: 2021-08-13
• Results First Submitted QC: 2021-12-17
• Results First Posted: 2022-01-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
CA-008 36 mg	CA-008	Single administration (0.3 mg/mL concentration)
CA-008 60 mg	CA-008	Single administration (0.5 mg/mL concentration)
Placebo	Placebo	Single administration
CA-008 90 mg	CA-008	Single administration (0.75 mg/mL concentration)

Primary Outcome Measures

Name	Time	Method
Pain Intensity Scores	0 to Day 15 post dose	Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) weighted sum of pain intensity scores (at rest) from 0-10 where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. AUC is calculated using the standard trapezoidal rule from serial measures of NRS taken every 4 hours from 0-96 hours following surgery and twice daily from 96h to Day 15

Secondary Outcome Measures

Name	Time	Method
Total Opioid Consumption	0 to Day 15 post dose	CA-008 versus placebo comparison, total opioid consumption in oral morphine equivalents

Trial Locations

Locations (4)

Lotus Clinical Reserach, LLC; 🇺🇸 Pasadena, California, United States

Plano Surgical Hospital; 🇺🇸 Plano, Texas, United States

Legent Orthopedic Hospital; 🇺🇸 Carrollton, Texas, United States

First Surgical Hospital; 🇺🇸 Houston, Texas, United States