Open-Label CA-008 (Vocacapsaicin) in Bunionectomy

Concentric Analgesics36 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain

Interventions

CA-008DRUG

Drug: CA-008 4.2 mg reconstituted in saline

KetorolacDRUG

30 mg IV at the onset of anesthesia

Acetaminophen IVDRUG

1 g at the onset of anesthesia

Fentanyl

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Healthy adult aged 18 - 65 years old 2. American Society of Anesthesiology (ASA) physical Class 1, 2 or 3 3. Planning elective Bunionectomy repair 4. For both males and females: using an acceptable method of birth control 5. If a female: not pregnant or breastfeeding 6. Have a body mass index ≤ 36 kg/m2 Exclusion Criteria: 1. Have another painful condition, other than bunion-related pain, that may require pain treatment during the study period 2. Have active skin disease or another abnormality at the anticipated site of surgery that could interfere with the planned surgery. 3. Have a known allergy to study medications. 4. Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values 5. Have positive results on the alcohol test (breath or saliva) or urine drug screen.

Locations (1)

Lotus Clinical Research, LLC

Pasadena, California, United States

Outcomes

Primary Outcomes

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

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

Time frame: 0-72 hours

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

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

Time frame: 24 hours

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

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

Time frame: 48 hours

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

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

Time frame: 72 hours

Secondary Outcomes

Opioid Consumption

Summary of opioid consumption in oral morphine equivalents

Time frame: 0-72 hours

Data from ClinicalTrials.gov

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