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Completed

NCT Number: NCT03599089

Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating a single dose of one of three CA-008 dose levels vs. placebo injected during an elective bunionectomy Bunionectomy to assess post-surgical pain management and the need for rescue medication (oxycodone).

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Key information

Conditions

Post-surgical Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Loading trial locations.

About this study

Primary Objective:

To evaluate the efficacy of a single intraoperative administration of CA- 008 vs placebo in subjects undergoing an elective Bunionectomy .

Secondary Objectives

  • To evaluate the safety and tolerability of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy.
  • To evaluate the PK profile of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy .
  • To explore the efficacy of various doses of CA-008 administered intraoperatively in subjects undergoing an elective Bunionectomy .

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy adult aged 18 - 75 years old
  • American Society of Anesthesiology (ASA) physical Class 1, 2 or 3
  • Planning elective Bunionectomy repair
  • For both males and females: using an acceptable method of birth control
  • If a female: not pregnant or breastfeeding
  • Have a body mass index ≤ 40 kg/m2.
  • Be willing and able to sign the informed consent form (ICF)
  • Be able to complete study procedures and pain scales and to communicate meaningfully in English
  • Be willing to undergo 17 blood draws for pharmacokinetic (PK )assessments over 24 hours

Exclusion criteria

  • Have another painful condition, other than bunion-related pain, that may require pain treatment during the study period
  • Have active skin disease or another abnormality at the anticipated site of surgery that could interfere with the planned surgery.
  • Have a known allergy to chili peppers, capsaicin or the components of CA-008, bupivacaine HCl, ketorolac, acetaminophen or oxycodone.
  • Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
  • Be on any medication not allowed per the protocol
  • Within the past year have a history of illicit drug use or prescription medicine or alcohol abuse
  • Have positive results on the alcohol test (breath or saliva) or urine drug screen
  • Have previously participated in a clinical study with CA-008.
  • Have participated in another clinical trial or used an investigational product within 30 days or five half-lives (whichever is longer)

Treatment and study plan

CA-008

Drug

single-dose wound infiltration prior to surgical incision closure

Other names: Vocacapsaicin

Placebo

Drug

single-dose wound infiltration prior to surgical incision closure

Ketorolac

Drug

30mg IV administered intraoperatively

Acetaminophen

Drug

1000mg IV administered intraoperatively

Oxycodone

Drug

5mg PO prn post-surgery

Bupivacaine Hydrochloride

Drug

0.5% infiltration pre-surgery

Primary outcomes

  1. Change in Postsurgical Pain Based on the Weighted Sum of Pain Intensity (SPI) Assessments Over 96 Hours of the NRS Scores = Area Under the Curve (AUC)

    Time frame: [time frame: 96 hours]

    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. The time was collected 0 to 96 hours post-dose

Secondary outcomes

  1. Percentage of Subjects Opioid Free

    Time frame: [time frame: 96 hours]

    Percentage of subjects who are opioid-free for CA-008 compared to placebo.

  2. Total Opioid Consumption (in Daily Morphine Equivalents)

    Time frame: [time frame: 96 hours]

    Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo

Sponsors and collaborators

Lead sponsor

Concentric Analgesics

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-blind, Placebo-controlled Safety, Pharmacokinetics and Efficacy Study of CA-008 in Subjects Undergoing Bunionectomy

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 26, 2018
Registry last updated
Aug 11, 2021

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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