Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients
NCT ID: NCT03599089
Last Updated: 2021-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
147 participants
INTERVENTIONAL
2018-07-09
2018-10-23
Brief Summary
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Detailed Description
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To evaluate the efficacy of a single intraoperative administration of CA- 008 vs placebo in subjects undergoing an elective Bunionectomy .
Secondary Objectives
* To evaluate the safety and tolerability of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy.
* To evaluate the PK profile of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy .
* To explore the efficacy of various doses of CA-008 administered intraoperatively in subjects undergoing an elective Bunionectomy .
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CA-008 (vocacapsaicin) 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 (vocacapsaicin) 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 (vocacapsaicin) 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
Interventions
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CA-008
single-dose wound infiltration prior to surgical incision closure
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 ≤ 40 kg/m2.
7. Be willing and able to sign the informed consent form (ICF)
8. Be able to complete study procedures and pain scales and to communicate meaningfully in English
9. Be willing to undergo 17 blood draws for pharmacokinetic (PK )assessments over 24 hours
Exclusion Criteria
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 chili peppers, capsaicin or the components of CA-008, bupivacaine HCl, ketorolac, acetaminophen or oxycodone.
4. Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
5. Be on any medication not allowed per the protocol
6. Within the past year have a history of illicit drug use or prescription medicine or alcohol abuse
7. Have positive results on the alcohol test (breath or saliva) or urine drug screen
8. Have previously participated in a clinical study with CA-008.
9. Have participated in another clinical trial or used an investigational product within 30 days or five half-lives (whichever is longer)
18 Years
75 Years
ALL
No
Sponsors
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Concentric Analgesics
INDUSTRY
Responsible Party
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Principal Investigators
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Nancy Wu
Role: STUDY_DIRECTOR
Concentric Analgesics
Locations
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Lotus Clinical Research, LLC
Pasadena, California, United States
Chesapeake Research Group
Pasadena, Maryland, United States
HD Research Corp
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CA-PS-201
Identifier Type: -
Identifier Source: org_study_id
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