Phase 2 N=36 Treatment

Open-Label CA-008 (Vocacapsaicin) in Bunionectomy

Pain

Bottom Line

View on ClinicalTrials.gov: NCT03885596 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcome: Primary: Area Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h — 72.30; 66.24; 203.76; 306.58 score on a scale*hour

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: CA-008 (Drug); Ketorolac (Drug); Acetaminophen IV (Drug); Fentanyl (Drug); Bupivacaine Hydrochloride (Drug); Lidocaine HCl (Drug); Celecoxib (Drug); Acetaminophen Oral (Drug); Lidocaine Hydrochloride (Drug); Exparel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Concentric Analgesics
Primary completion: Jul 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Area Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h	72.30; 66.24; 203.76; 306.58	—
PRIMARY Pain Intensity Scores at 24 Hours at Rest Using Numerical Rating Scale (NRS)	0.6; 1.7; 5.1; 6.0	—
PRIMARY Pain Intensity Scores at 48 Hours at Rest Using Numerical Rating Scale (NRS)	1.3; 0.6; 2.7; 4.8	—
PRIMARY Pain Intensity Scores at 72 Hours at Rest Using Numerical Rating Scale (NRS)	1.2; 0.3; 2.0; 4.6	—
SECONDARY Opioid Consumption	10.83; 3.33; 38.33; 80.83	—

Summary

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03885596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.