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Completed

NCT Number: NCT04203537

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Lotus Clinical Reserach, LLC, Pasadena, California, United States

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About this study

Not provided

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CA-008

Drug

Local administration during surgery

Other names: vocacapsaicin

Placebo

Drug

Local administration during surgery

Primary outcomes

  1. Pain Intensity Scores

    Time frame: 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 outcomes

  1. Total Opioid Consumption

    Time frame: 0 to Day 15 post dose

    CA-008 versus placebo comparison, total opioid consumption in oral morphine equivalents

Sponsors and collaborators

Lead sponsor

Concentric Analgesics

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 18, 2019
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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