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
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).
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