PainPhase 2NCT03885596
Open-Label CA-008 (Vocacapsaicin) in Bunionectomy
A Phase 2 study testing CA-008, Ketorolac and Acetaminophen IV in people with Pain, run by Concentric Analgesics at 1 site in United States.
Trial summary
A Phase 2, open-label study of CA-008 to evaluate post-surgical pain control with CA-008. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- CA-008, Ketorolac and Acetaminophen IV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 22 Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lotus Clinical Research, LLC
Pasadena, California, 91105
About this study
Official title: An Open-Label Study of Intraoperative CA-008 Administration in Subjects Undergoing Bunionectomy
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
- Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CA-008Drug
Also called Vocacapsaicin
Drug: CA-008 4.2 mg reconstituted in saline
KetorolacDrug
30 mg IV at the onset of anesthesia
Acetaminophen IVDrug
1 g at the onset of anesthesia
FentanylDrug
100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine HydrochlorideDrug
0.25% 30 mL (75 mg) prior to surgery
Lidocaine HClDrug
1.5% 12 mL at the end of surgery
CelecoxibDrug
200 mg PO bid each day postoperative
Acetaminophen OralDrug
1 g postoperative
Lidocaine HydrochlorideDrug
2% 15 mL at the end of surgery
ExparelDrug
Bupivacaine liposome injection suspension
| Study group | Role | What they receive |
|---|---|---|
| CA-008 Cohort 1 | Experimental | 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. Receives: Drug: CA-008; Drug: Ketorolac; Drug: Acetaminophen IV; Drug: Fentanyl; Drug: Bupivacaine Hydrochloride; Drug: Lidocaine HCl; Drug: Celecoxib; Drug: Acetaminophen Oral |
| CA-008 Cohort 2 | Experimental | CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block. Receives: Drug: CA-008; Drug: Ketorolac; Drug: Acetaminophen IV; Drug: Fentanyl; Drug: Bupivacaine Hydrochloride; Drug: Celecoxib; Drug: Acetaminophen Oral; Drug: Lidocaine Hydrochloride |
| CA-008 Cohort 3 | Experimental | CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block. Receives: Drug: CA-008; Drug: Ketorolac; Drug: Acetaminophen IV; Drug: Fentanyl; Drug: Bupivacaine Hydrochloride; Drug: Lidocaine Hydrochloride |
| Exparel | Active comparator | 106 mg [8 mL of the 133 mg/10 mL suspension] only
All subjects received monitored anesthesia care (MAC) and a Mayo block. Receives: Drug: Ketorolac; Drug: Acetaminophen IV; Drug: Fentanyl; Drug: Bupivacaine Hydrochloride; Drug: Lidocaine Hydrochloride; Drug: Exparel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 72 hours
Secondary outcomes (1)
Opioid Consumption
Summary of opioid consumption in oral morphine equivalents
Measured: 0-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start25 Mar 2019
- Primary completion2 Jul 2019
- Study completion22 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concentric Analgesics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy Wu, Study director, Concentric Analgesics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03885596
- Sponsor's protocol ID
- CA-PS-205
- Status last verified
- Sep 2021
- First submitted
- 20 Mar 2019
- Last updated
- 27 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Intraoperative CA-008 Administration in Subjects Undergoing Bunionectomy
- ClinicalTrials.gov ID
- NCT03885596
- Acronym / sponsor ID
- CA-PS-205
- Conditions
- Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Concentric AnalgesicsIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 2 Jul 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 21 Mar 2019 (actual)
- Results
- Posted 27 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CA-008 Cohort 1 | Experimental | Drug: CA-008, Drug: Ketorolac, Drug: Acetaminophen IV, Drug: Fentanyl, Drug: Bupivacaine Hydrochloride, Drug: Lidocaine HCl, Drug: Celecoxib, Drug: Acetaminophen OralCA-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 | Experimental | Drug: CA-008, Drug: Ketorolac, Drug: Acetaminophen IV, Drug: Fentanyl, Drug: Bupivacaine Hydrochloride, Drug: Celecoxib, Drug: Acetaminophen Oral, Drug: Lidocaine HydrochlorideCA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block. |
| CA-008 Cohort 3 | Experimental | Drug: CA-008, Drug: Ketorolac, Drug: Acetaminophen IV, Drug: Fentanyl, Drug: Bupivacaine Hydrochloride, Drug: Lidocaine HydrochlorideCA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block. |
| Exparel | Active comparator | Drug: Ketorolac, Drug: Acetaminophen IV, Drug: Fentanyl, Drug: Bupivacaine Hydrochloride, Drug: Lidocaine Hydrochloride, Drug: Exparel106 mg [8 mL of the 133 mg/10 mL suspension] only All subjects received monitored anesthesia care (MAC) and a Mayo block. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CA-008Also: VocacapsaicinDrug: CA-008 4.2 mg reconstituted in saline | Drug | CA-008 Cohort 1, CA-008 Cohort 2, CA-008 Cohort 3 |
| Ketorolac30 mg IV at the onset of anesthesia | Drug | CA-008 Cohort 1, CA-008 Cohort 2, CA-008 Cohort 3, Exparel |
| Acetaminophen IV1 g at the onset of anesthesia | Drug | CA-008 Cohort 1, CA-008 Cohort 2, CA-008 Cohort 3, Exparel |
| Fentanyl100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery | Drug | CA-008 Cohort 1, CA-008 Cohort 2, CA-008 Cohort 3, Exparel |
| Bupivacaine Hydrochloride0.25% 30 mL (75 mg) prior to surgery | Drug | CA-008 Cohort 1, CA-008 Cohort 2, CA-008 Cohort 3, Exparel |
| Lidocaine HCl1.5% 12 mL at the end of surgery | Drug | CA-008 Cohort 1 |
| Celecoxib200 mg PO bid each day postoperative | Drug | CA-008 Cohort 1, CA-008 Cohort 2 |
| Acetaminophen Oral1 g postoperative | Drug | CA-008 Cohort 1, CA-008 Cohort 2 |
| Lidocaine Hydrochloride2% 15 mL at the end of surgery | Drug | CA-008 Cohort 2, CA-008 Cohort 3, Exparel |
| ExparelBupivacaine liposome injection suspension | Drug | Exparel |
Primary outcome
Area Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
1 secondary outcome
Opioid Consumption
Time frame: 0-72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Wu study director
Concentric Analgesics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CA-008, Ketorolac and Acetaminophen IV in people with Pain, run by Concentric Analgesics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h (time frame: 0-72 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.