CompletedNCT03885596Updated Oct 27, 2021Results posted

Open-Label CA-008 (Vocacapsaicin) in Bunionectomy

A Phase 2 interventional study of CA-008 and Ketorolac in Pain, sponsored by Concentric Analgesics. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-10-27.

Sponsored by Concentric Analgesics · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 36
Allocation: Non-randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

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

Read the 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).

Conditions studied

Pain

Browse trials for

Pain 10,054

In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's enrollment of 36 is below the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Concentric Analgesics is the lead sponsor of 7 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
If a female: not pregnant or breastfeeding
Have a ≤ 36 kg/m2

Exclusion criteria

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 abnormal clinical laboratory test values
Have positive results on the alcohol test (breath or saliva) or urine drug screen.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 36 participants (actual)

Study arms

Experimental
CA-008 Cohort 1
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.
Drug: CA-008 · Drug: Ketorolac · Drug: Acetaminophen IV · Drug: Fentanyl · Drug: Bupivacaine Hydrochloride · Drug: Lidocaine HCl · Drug: Celecoxib · Drug: Acetaminophen Oral
Experimental
CA-008 Cohort 2
CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
Drug: CA-008 · Drug: Ketorolac · Drug: Acetaminophen IV · Drug: Fentanyl · Drug: Bupivacaine Hydrochloride · Drug: Celecoxib · Drug: Acetaminophen Oral · Drug: Lidocaine Hydrochloride
Experimental
CA-008 Cohort 3
CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
Drug: CA-008 · Drug: Ketorolac · Drug: Acetaminophen IV · Drug: Fentanyl · Drug: Bupivacaine Hydrochloride · Drug: Lidocaine Hydrochloride
Active comparator
Exparel
106 mg \[8 mL of the 133 mg/10 mL suspension\] only All subjects received monitored anesthesia care (MAC) and a Mayo block.
Drug: Ketorolac · Drug: Acetaminophen IV · Drug: Fentanyl · Drug: Bupivacaine Hydrochloride · Drug: Lidocaine Hydrochloride · Drug: Exparel

Interventions

DrugCA-008
Drug: CA-008 4.2 mg reconstituted in saline
Also known as: Vocacapsaicin
DrugKetorolac
30 mg IV at the onset of anesthesia
DrugAcetaminophen IV
1 g at the onset of anesthesia
DrugFentanyl
100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
DrugBupivacaine Hydrochloride
0.25% 30 mL (75 mg) prior to surgery
DrugLidocaine HCl
1.5% 12 mL at the end of surgery
DrugCelecoxib
200 mg PO bid each day postoperative
DrugAcetaminophen Oral
1 g postoperative
DrugLidocaine Hydrochloride
2% 15 mL at the end of surgery
DrugExparel
Bupivacaine liposome injection suspension

What researchers measure

Primary outcomes

Area Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h
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
Time frame: 0-72 hours
Pain Intensity Scores at 24 Hours at Rest Using Numerical Rating Scale (NRS)
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
Time frame: 24 hours
Pain Intensity Scores at 48 Hours at Rest Using Numerical Rating Scale (NRS)
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
Time frame: 48 hours
Pain Intensity Scores at 72 Hours at Rest Using Numerical Rating Scale (NRS)
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
Time frame: 72 hours

Secondary outcomes

Opioid Consumption
Summary of opioid consumption in oral morphine equivalents
Time frame: 0-72 hours

Results

Posted Oct 27, 2021

Participant flow

Participant flow — Overall Study
Milestone	CA-008 Cohort 1	CA-008 Cohort 2	CA-008 Cohort 3	Exparel
Started	9	9	9	9
Completed	7	8	9	9
Not completed	2	1	0	0
Withdrew: Withdrawal by subject	2	1	0	0

Outcome measures

PrimaryArea Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h

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

Time frame:: 0-72 hours
Reported as:: Mean · score on a scale*hour

Area Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h
score on a scale*hour	CA-008 Cohort 1	CA-008 Cohort 2	CA-008 Cohort 3	Exparel
Area Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h	72.30 ± 95.476	66.24 ± 54.365	203.76 ± 103.718	306.58 ± 92.883

SecondaryOpioid Consumption

Summary of opioid consumption in oral morphine equivalents

Time frame:: 0-72 hours
Reported as:: Mean · mg morphine equivalents

Opioid Consumption
mg morphine equivalents	CA-008 (Vocacapsaicin) Cohort 1	CA-008 (Vocacapsaicin) Cohort 2	CA-008 (Vocacapsaicin) Cohort 3	Exparel
Opioid Consumption	10.83 ± 27.33	3.33 ± 6.61	38.33 ± 26.90	80.83 ± 66.95

PrimaryPain Intensity Scores at 24 Hours at Rest Using Numerical Rating Scale (NRS)

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

Time frame:: 24 hours
Reported as:: Mean · units on a scale

Pain Intensity Scores at 24 Hours at Rest Using Numerical Rating Scale (NRS)
units on a scale	CA-008 Cohort 1	CA-008 Cohort 2	CA-008 Cohort 3	Exparel
Pain Intensity Scores at 24 Hours at Rest Using Numerical Rating Scale (NRS)	0.6 ± 0.88	1.7 ± 1.66	5.1 ± 1.45	6.0 ± 1.00

PrimaryPain Intensity Scores at 48 Hours at Rest Using Numerical Rating Scale (NRS)

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

Time frame:: 48 hours
Reported as:: Mean · score on a scale

Pain Intensity Scores at 48 Hours at Rest Using Numerical Rating Scale (NRS)
score on a scale	CA-008 Cohort 1	CA-008 Cohort 2	CA-008 Cohort 3	Exparel
Pain Intensity Scores at 48 Hours at Rest Using Numerical Rating Scale (NRS)	1.3 ± 2.12	0.6 ± 0.73	2.7 ± 2.45	4.8 ± 2.11

PrimaryPain Intensity Scores at 72 Hours at Rest Using Numerical Rating Scale (NRS)

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

Time frame:: 72 hours
Reported as:: Mean · score on a scale

Pain Intensity Scores at 72 Hours at Rest Using Numerical Rating Scale (NRS)
score on a scale	CA-008 Cohort 1	CA-008 Cohort 2	CA-008 Cohort 3	Exparel
Pain Intensity Scores at 72 Hours at Rest Using Numerical Rating Scale (NRS)	1.2 ± 2.28	0.3 ± 0.71	2.0 ± 2.12	4.6 ± 2.88

Adverse events

Collected over Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
CA-008 Cohort 1	0/9 (0%)	0/9 (0%)	1/9 (11.1%)
CA-008 Cohort 2	0/9 (0%)	0/9 (0%)	4/9 (44.4%)
CA-008 Cohort 3	0/9 (0%)	0/9 (0%)	5/9 (55.6%)
Exparel	0/9 (0%)	0/9 (0%)	5/9 (55.6%)

Most frequent other events

Showing 10 of 13

Most frequent other events
Event	CA-008 Cohort 1	CA-008 Cohort 2	CA-008 Cohort 3	Exparel
ConstipationGastrointestinal disorders	0/9	0/9	0/9	3/9
Procedural painInjury, poisoning and procedural complications	0/9	0/9	3/9	0/9
DiarrhoeaGastrointestinal disorders	0/9	0/9	0/9	1/9
NauseaGastrointestinal disorders	0/9	1/9	1/9	1/9
VomitingGastrointestinal disorders	0/9	0/9	1/9	0/9
GastroenteritisInfections and infestations	0/9	1/9	0/9	0/9
Incision site painInjury, poisoning and procedural complications	1/9	0/9	0/9	0/9
DizzinessNervous system disorders	0/9	0/9	1/9	1/9
HeadacheNervous system disorders	0/9	1/9	1/9	1/9
Sensory disturbanceNervous system disorders	1/9	1/9	0/9	0/9

Baseline characteristics

Age, Continuous
Age, Continuous(years)	CA-008 (Vocacapsaicin) Cohort 1	CA-008 (Vocacapsaicin) Cohort 2	CA-008 (Vocacapsaicin) Cohort 3	Exparel	Total
Mean	49.1 ± 9.96	43.1 ± 9.20	35.2 ± 12.71	52.8 ± 6.72	45.05 ± 9.65

Sex: Female, Male
Sex: Female, Male(Participants)	CA-008 (Vocacapsaicin) Cohort 1	CA-008 (Vocacapsaicin) Cohort 2	CA-008 (Vocacapsaicin) Cohort 3	Exparel	Total
Female	7	7	8	5	27
Male	2	2	1	4	9

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	CA-008 (Vocacapsaicin) Cohort 1	CA-008 (Vocacapsaicin) Cohort 2	CA-008 (Vocacapsaicin) Cohort 3	Exparel	Total
Hispanic or Latino	4	2	6	4	16
Not Hispanic or Latino	5	7	3	5	20
Unknown or Not Reported	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	CA-008 (Vocacapsaicin) Cohort 1	CA-008 (Vocacapsaicin) Cohort 2	CA-008 (Vocacapsaicin) Cohort 3	Exparel	Total
American Indian or Alaska Native	1	0	0	0	1
Asian	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	1	0	1
Black or African American	2	4	2	2	10
White	6	4	6	7	23
More than one race	0	1	0	0	1
Unknown or Not Reported	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	CA-008 (Vocacapsaicin) Cohort 1	CA-008 (Vocacapsaicin) Cohort 2	CA-008 (Vocacapsaicin) Cohort 3	Exparel	Total
United States	9	9	9	9	36

Study locations

1 site

Lotus Clinical Research, LLC
Pasadena, California 91105, United States

References and documents

Study documents

Study protocol ↗ · May 2, 2019
Statistical analysis plan ↗ · Jun 5, 2019

PDFs hosted by the registry, ClinicalTrials.gov.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2019 to primary completion in Jul 2019, 3 months.

Results were first posted in Oct 2021, 2 years 3 months after primary completion. A results delay was requested in Sep 2020.

Of 62 industry-sponsored phase 2 interventional studies under Pain, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 19. This study's 3 months is below that.

Counting every sponsor, half of 186 studies reached it within 21 months; a quarter within 7 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 20, 2019
First posted: Mar 21, 2019
StartActual: Mar 25, 2019
Primary completionActual: Jul 2, 2019
CompletionActual: Oct 22, 2019
Results delay requested: Sep 12, 2020
Results first posted: Oct 27, 2021
Last update: Oct 27, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Oct 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03885596
Lead sponsor: Concentric Analgesics
Responsible party: Sponsor
First posted: Mar 21, 2019
Start date: Mar 25, 2019
Primary completion: Jul 2, 2019
Completion: Oct 22, 2019
Results posted: Oct 27, 2021
Last update: Oct 27, 2021

Study contacts

Nancy Wu

study director · Concentric Analgesics

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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