Open-Label CA-008 (Vocacapsaicin) in Bunionectomy

Completed · Phase 2

Conditions studied: Pain

In brief

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

Key facts

Study ID

NCT03885596

Run by

Concentric Analgesics

People needed

36

Starts

2019-03-25

Expected to finish

2019-10-22

Last updated by the study team

2021-10-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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