Trial Outcomes & Findings for Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients (NCT NCT03599089)

Last Updated: 2021-08-11

Results Overview

Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) weighted sum of pain intensity scores (at rest) from 0-10 where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. The time was collected 0 to 96 hours post-dose

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

147 participants

Primary outcome timeframe

[time frame: 96 hours]

Results posted on

2021-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	CA-008 0.7 mg (0.05 mg/mL Concentration) Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	CA-008 2.1 mg (0.15 mg/mL Concentration) Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	CA-008 4.2 mg (0.3 mg/mL Concentration) Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	Placebo Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. Placebo: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery
Overall Study STARTED	36	36	38	37
Overall Study COMPLETED	33	35	37	35
Overall Study NOT COMPLETED	3	1	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	CA-008 0.7 mg (0.05 mg/mL Concentration) Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	CA-008 2.1 mg (0.15 mg/mL Concentration) Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	CA-008 4.2 mg (0.3 mg/mL Concentration) Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	Placebo Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. Placebo: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery
Overall Study Lost to Follow-up	1	0	0	0
Overall Study Withdrawal by Subject	2	1	0	0
Overall Study Lack of Efficacy	0	0	1	2

Baseline Characteristics

Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CA-008 0.7 mg (0.05 mg/mL Concentration) n=36 Participants Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	CA-008 2.1 mg (0.15 mg/mL Concentration) n=36 Participants Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	CA-008 4.2 mg (0.3 mg/mL Concentration) n=38 Participants Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	Placebo n=37 Participants Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. Placebo: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	Total n=147 Participants Total of all reporting groups
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Age, Continuous	48.9 years STANDARD_DEVIATION 12.29 • n=5 Participants	44.6 years STANDARD_DEVIATION 12.33 • n=7 Participants	41.4 years STANDARD_DEVIATION 12.16 • n=5 Participants	50.7 years STANDARD_DEVIATION 12.46 • n=4 Participants	46.4 years STANDARD_DEVIATION 12.73 • n=21 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	25 Participants n=7 Participants	34 Participants n=5 Participants	31 Participants n=4 Participants	123 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	11 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	24 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	12 Participants n=4 Participants	39 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=5 Participants	25 Participants n=7 Participants	30 Participants n=5 Participants	25 Participants n=4 Participants	108 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants	14 Participants n=4 Participants	52 Participants n=21 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	22 Participants n=4 Participants	81 Participants n=21 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	36 Participants n=5 Participants	36 Participants n=7 Participants	38 Participants n=5 Participants	37 Participants n=4 Participants	147 Participants n=21 Participants

PRIMARY outcome

Timeframe: [time frame: 96 hours]

Population: Modified Intent to Treat

Outcome measures

Outcome measures
Measure	CA-008 0.7 mg (0.05 mg/mL Concentration) n=36 Participants Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	CA-008 2.1 mg (0.15 mg/mL Concentration) n=36 Participants Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	CA-008 4.2 mg (0.3 mg/mL Concentration) n=38 Participants Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	Placebo n=37 Participants Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. Placebo: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery
Change in Postsurgical Pain Based on the Weighted Sum of Pain Intensity (SPI) Assessments Over 96 Hours of the NRS Scores = Area Under the Curve (AUC)	317.09 scores on a scale*hour Standard Deviation 204.291	321.72 scores on a scale*hour Standard Deviation 165.145	266.86 scores on a scale*hour Standard Deviation 220.674	400.56 scores on a scale*hour Standard Deviation 215.471

SECONDARY outcome

Timeframe: [time frame: 96 hours]

Population: Modified Intent to Treat

Percentage of subjects who are opioid-free for CA-008 compared to placebo.

Outcome measures

Outcome measures
Measure	CA-008 0.7 mg (0.05 mg/mL Concentration) n=36 Participants Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	CA-008 2.1 mg (0.15 mg/mL Concentration) n=36 Participants Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	CA-008 4.2 mg (0.3 mg/mL Concentration) n=38 Participants Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	Placebo n=37 Participants Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. Placebo: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery
Percentage of Subjects Opioid Free	19.4 percentage of subjects	16.7 percentage of subjects	26.3 percentage of subjects	5.4 percentage of subjects

SECONDARY outcome

Timeframe: [time frame: 96 hours]

Population: Modified Intent to Treat

Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo

Outcome measures

Outcome measures
Measure	CA-008 0.7 mg (0.05 mg/mL Concentration) n=36 Participants Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	CA-008 2.1 mg (0.15 mg/mL Concentration) n=36 Participants Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	CA-008 4.2 mg (0.3 mg/mL Concentration) n=38 Participants Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	Placebo n=37 Participants Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. Placebo: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery
Total Opioid Consumption (in Daily Morphine Equivalents)	42.50 mg morphine equivalents/day Standard Deviation 38.074	37.71 mg morphine equivalents/day Standard Deviation 39.340	28.22 mg morphine equivalents/day Standard Deviation 28.355	56.11 mg morphine equivalents/day Standard Deviation 45.447

Adverse Events

CA-008 0.7 mg (0.05 mg/mL Concentration)

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

CA-008 2.1 mg (0.15 mg/mL Concentration)

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

CA-008 4.2 mg (0.3 mg/mL Concentration)

Serious events: 0 serious events

Other events: 26 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CA-008 0.7 mg (0.05 mg/mL Concentration) n=36 participants at risk Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	CA-008 2.1 mg (0.15 mg/mL Concentration) n=36 participants at risk Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	CA-008 4.2 mg (0.3 mg/mL Concentration) n=38 participants at risk Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery	Placebo n=37 participants at risk Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. Placebo: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery
Infections and infestations Cellulitis on left big toe	0.00% 0/36 • Adverse event data was collected from the time that each participant provided written informed consent (up to 45-day screening period) through Day 36+2 days. The total duration could be a maximum of 83 days.	0.00% 0/36 • Adverse event data was collected from the time that each participant provided written informed consent (up to 45-day screening period) through Day 36+2 days. The total duration could be a maximum of 83 days.	0.00% 0/38 • Adverse event data was collected from the time that each participant provided written informed consent (up to 45-day screening period) through Day 36+2 days. The total duration could be a maximum of 83 days.	2.7% 1/37 • Number of events 1 • Adverse event data was collected from the time that each participant provided written informed consent (up to 45-day screening period) through Day 36+2 days. The total duration could be a maximum of 83 days.

Other adverse events

Additional Information

Head of Clinical Operations

Concentric Analgesics

Phone: 14154847921

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place