Open-Label CA-008 (Vocacapsaicin) in Bunionectomy

Phase 2

Completed

• Conditions: Pain
• Interventions: Drug: CA-008; Drug: Ketorolac; Drug: Acetaminophen IV; Drug: Fentanyl; Drug: Bupivacaine Hydrochloride; Drug: Lidocaine HCl; Drug: Exparel; Drug: Acetaminophen Oral; Drug: Celecoxib; Drug: Lidocaine Hydrochloride

• Registration Number: NCT03885596
• Lead Sponsor: Concentric Analgesics

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-20
• Study First Posted: 2019-03-21
• Study Start: 2019-03-25
• Primary Completion: 2019-07-02
• Study Completion: 2019-10-22
• Disposition First Submitted: 2020-09-12
• Results First Submitted: 2021-08-12
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-29
• Disposition First Submitted QC: 2021-09-29
• Last Update Submitted: 2021-09-29
• Results First Posted: 2021-10-27
• Disposition First Posted: 2021-10-27
• Last Update Posted: 2021-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CA-008 Cohort 2	Acetaminophen Oral	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008 Cohort 1	Acetaminophen Oral	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.
CA-008 Cohort 1	CA-008	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.
CA-008 Cohort 1	Acetaminophen IV	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.
CA-008 Cohort 2	Acetaminophen IV	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008 Cohort 2	CA-008	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008 Cohort 3	CA-008	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
Exparel	Acetaminophen IV	106 mg \[8 mL of the 133 mg/10 mL suspension\] only All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008 Cohort 3	Acetaminophen IV	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008 Cohort 1	Ketorolac	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.
CA-008 Cohort 1	Fentanyl	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.
CA-008 Cohort 1	Bupivacaine Hydrochloride	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.
CA-008 Cohort 2	Fentanyl	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008 Cohort 1	Lidocaine HCl	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.
CA-008 Cohort 2	Ketorolac	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008 Cohort 1	Celecoxib	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.
CA-008 Cohort 2	Bupivacaine Hydrochloride	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008 Cohort 2	Celecoxib	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008 Cohort 2	Lidocaine Hydrochloride	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008 Cohort 3	Ketorolac	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008 Cohort 3	Fentanyl	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008 Cohort 3	Bupivacaine Hydrochloride	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008 Cohort 3	Lidocaine Hydrochloride	CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
Exparel	Ketorolac	106 mg \[8 mL of the 133 mg/10 mL suspension\] only All subjects received monitored anesthesia care (MAC) and a Mayo block.
Exparel	Fentanyl	106 mg \[8 mL of the 133 mg/10 mL suspension\] only All subjects received monitored anesthesia care (MAC) and a Mayo block.
Exparel	Lidocaine Hydrochloride	106 mg \[8 mL of the 133 mg/10 mL suspension\] only All subjects received monitored anesthesia care (MAC) and a Mayo block.
Exparel	Bupivacaine Hydrochloride	106 mg \[8 mL of the 133 mg/10 mL suspension\] only All subjects received monitored anesthesia care (MAC) and a Mayo block.
Exparel	Exparel	106 mg \[8 mL of the 133 mg/10 mL suspension\] only All subjects received monitored anesthesia care (MAC) and a Mayo block.

Primary Outcome Measures

Name	Time	Method
Area Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h	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
Pain Intensity Scores at 24 Hours at Rest Using Numerical Rating Scale (NRS)	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
Pain Intensity Scores at 48 Hours at Rest Using Numerical Rating Scale (NRS)	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
Pain Intensity Scores at 72 Hours at Rest Using Numerical Rating Scale (NRS)	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 Outcome Measures

Name	Time	Method
Opioid Consumption	0-72 hours	Summary of opioid consumption in oral morphine equivalents

Trial Locations

Locations (1)

Lotus Clinical Research, LLC; 🇺🇸 Pasadena, California, United States