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Completed

NCT Number: NCT03885596

Open-Label CA-008 (Vocacapsaicin) in Bunionectomy

A Phase 2, open-label study of CA-008 to evaluate post-surgical pain control with CA-008.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

About this study

This is a Phase 2, single-center, open-label study evaluating a single dose of CA-008 4.2 mg administered with different standard-of-care anesthetic regimens during an elective unilateral transpositional first metatarsal osteotomy for the correction of hallux valgus deformity (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 - 65 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 ≤ 36 kg/m2

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 study medications.
  • Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
  • Have positive results on the alcohol test (breath or saliva) or urine drug screen.

Treatment and study plan

CA-008

Drug

Drug: CA-008 4.2 mg reconstituted in saline

Other names: Vocacapsaicin

Ketorolac

Drug

30 mg IV at the onset of anesthesia

Acetaminophen IV

Drug

1 g at the onset of anesthesia

Fentanyl

Drug

100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery

Bupivacaine Hydrochloride

Drug

0.25% 30 mL (75 mg) prior to surgery

Lidocaine HCl

Drug

1.5% 12 mL at the end of surgery

Celecoxib

Drug

200 mg PO bid each day postoperative

Acetaminophen Oral

Drug

1 g postoperative

Lidocaine Hydrochloride

Drug

2% 15 mL at the end of surgery

Exparel

Drug

Bupivacaine liposome injection suspension

Primary outcomes

  1. Area Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h

    Time frame: 0-72 hours

    Area Under the Curve of pain intensity scores (using a Numeric Rating Scale of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable) over 72 hours

  2. Pain Intensity Scores at 24 Hours at Rest Using Numerical Rating Scale (NRS)

    Time frame: 24 hours

    Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 24 hours

  3. Pain Intensity Scores at 48 Hours at Rest Using Numerical Rating Scale (NRS)

    Time frame: 48 hours

    Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 48 hours

  4. Pain Intensity Scores at 72 Hours at Rest Using Numerical Rating Scale (NRS)

    Time frame: 72 hours

    Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 72 hours

Secondary outcomes

  1. Opioid Consumption

    Time frame: 0-72 hours

    Summary of opioid consumption in oral morphine equivalents

Sponsors and collaborators

Lead sponsor

Concentric Analgesics

Industry

Registry information

Official study title

An Open-Label Study of Intraoperative CA-008 Administration in Subjects Undergoing Bunionectomy

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 21, 2019
Registry last updated
Oct 27, 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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