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

NCT04203537 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: CA-PS-208
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 4

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.

Conditions

Postsurgical Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total Opioid Consumption

  0 to Day 15 post dose

Study Arms (4)

CA-008 36 mg

ACTIVE COMPARATOR

Single administration (0.3 mg/mL concentration)

Drug: CA-008

CA-008 60 mg

ACTIVE COMPARATOR

Single administration (0.5 mg/mL concentration)

Drug: CA-008

CA-008 90 mg

ACTIVE COMPARATOR

Single administration (0.75 mg/mL concentration)

Drug: CA-008

Placebo

PLACEBO COMPARATOR

Single administration

Drug: Placebo

Interventions

CA-008 DRUG

Local administration during surgery

Also known as: vocacapsaicin

CA-008 36 mg; CA-008 60 mg; CA-008 90 mg

Placebo DRUG

Local administration during surgery

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Concentric Analgesics: lead

Study Sites (4)

Lotus Clinical Reserach, LLC

Pasadena, California, 91105, United States

Location

Legent Orthopedic Hospital

Carrollton, Texas, 75006, United States

Location

First Surgical Hospital

Houston, Texas, 77401, United States

Location

Plano Surgical Hospital

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Nancy Wu
• Organization: Concentric Analgesics

nancy@concentricanalgesics.com

(415) 484-7921

Study Officials

• Daneshvari Solanki, MD

  HD Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A: dose ascending, placebo-controlled Part B: randomized, double-blind, placebo-controlled, parallel design

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 18, 2019
• Study Start: December 4, 2019
• Primary Completion: October 26, 2020
• Study Completion: October 26, 2020
• Last Updated: May 8, 2024
• Results First Posted: January 12, 2022

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)