Open-Label CA-008 (Vocacapsaicin) in Bunionectomy
An Open-Label Study of Intraoperative CA-008 Administration in Subjects Undergoing Bunionectomy
1 other identifier
interventional
36
1 country
1
Brief Summary
A Phase 2, open-label study of CA-008 to evaluate post-surgical pain control with CA-008.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 pain
Started Mar 2019
Shorter than P25 for phase_2 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2019
CompletedFirst Posted
Study publicly available on registry
March 21, 2019
CompletedStudy Start
First participant enrolled
March 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2019
CompletedResults Posted
Study results publicly available
October 27, 2021
CompletedOctober 27, 2021
September 1, 2021
3 months
March 20, 2019
August 12, 2021
September 29, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
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
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
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
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
72 hours
Secondary Outcomes (1)
Opioid Consumption
0-72 hours
Study Arms (4)
CA-008 Cohort 1
EXPERIMENTALCA-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
EXPERIMENTALCA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008 Cohort 3
EXPERIMENTALCA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.
Exparel
ACTIVE COMPARATOR106 mg \[8 mL of the 133 mg/10 mL suspension\] only All subjects received monitored anesthesia care (MAC) and a Mayo block.
Interventions
Drug: CA-008 4.2 mg reconstituted in saline
30 mg IV at the onset of anesthesia
1 g at the onset of anesthesia
100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
0.25% 30 mL (75 mg) prior to surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lotus Clinical Research, LLC
Pasadena, California, 91105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head of Clinical Operations
- Organization
- Concentric Analgesics
Study Officials
- STUDY DIRECTOR
Nancy Wu
Concentric Analgesics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2019
First Posted
March 21, 2019
Study Start
March 25, 2019
Primary Completion
July 2, 2019
Study Completion
October 22, 2019
Last Updated
October 27, 2021
Results First Posted
October 27, 2021
Record last verified: 2021-09