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

Postsurgical Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203537
• Other study ID #: CA-PS-208
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 4, 2019
• Est. completion date: October 26, 2020

Study information

• Verified date: April 2024
• Source: Concentric Analgesics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Not provided

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: October 26, 2020
• Est. primary completion date: October 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postsurgical Pain

Intervention

Drug:
• CA-008
Local administration during surgery
• Placebo
Local administration during surgery

Locations

Country	Name	City	State
United States	Legent Orthopedic Hospital	Carrollton	Texas
United States	First Surgical Hospital	Houston	Texas
United States	Lotus Clinical Reserach, LLC	Pasadena	California
United States	Plano Surgical Hospital	Plano	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Concentric Analgesics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity Scores	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	0 to Day 15 post dose
Secondary	Total Opioid Consumption	CA-008 versus placebo comparison, total opioid consumption in oral morphine equivalents	0 to Day 15 post dose