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Open-Label CA-008 (Vocacapsaicin) in Bunionectomy | Clinical Trials | Clareo Health

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COMPLETEDPhase 2NCT03885596

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.

Lead sponsor: Concentric Analgesics•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Concentric Analgesics

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).

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 27, 2021Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment36

Start dateMar 2019

Last updatedOct 27, 2021

Condition

Locations shown

Lotus Clinical Research, LLC

Pasadena, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 27, 2021Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions