Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
36 participants
INTERVENTIONAL
2019-03-25
2019-10-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
CA-008
Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac
30 mg IV at the onset of anesthesia
Acetaminophen IV
1 g at the onset of anesthesia
Fentanyl
100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride
0.25% 30 mL (75 mg) prior to surgery
Lidocaine HCl
1.5% 12 mL at the end of surgery
Celecoxib
200 mg PO bid each day postoperative
Acetaminophen Oral
1 g postoperative
CA-008 Cohort 2
CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008
Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac
30 mg IV at the onset of anesthesia
Acetaminophen IV
1 g at the onset of anesthesia
Fentanyl
100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride
0.25% 30 mL (75 mg) prior to surgery
Celecoxib
200 mg PO bid each day postoperative
Acetaminophen Oral
1 g postoperative
Lidocaine Hydrochloride
2% 15 mL at the end of surgery
CA-008 Cohort 3
CA-008 4.2 mg reconstituted in saline
All subjects received monitored anesthesia care (MAC) and a Mayo block.
CA-008
Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac
30 mg IV at the onset of anesthesia
Acetaminophen IV
1 g at the onset of anesthesia
Fentanyl
100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride
0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride
2% 15 mL at the end of surgery
Exparel
106 mg \[8 mL of the 133 mg/10 mL suspension\] only
All subjects received monitored anesthesia care (MAC) and a Mayo block.
Ketorolac
30 mg IV at the onset of anesthesia
Acetaminophen IV
1 g at the onset of anesthesia
Fentanyl
100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride
0.25% 30 mL (75 mg) prior to surgery
Lidocaine Hydrochloride
2% 15 mL at the end of surgery
Exparel
Bupivacaine liposome injection suspension
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CA-008
Drug: CA-008 4.2 mg reconstituted in saline
Ketorolac
30 mg IV at the onset of anesthesia
Acetaminophen IV
1 g at the onset of anesthesia
Fentanyl
100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
Bupivacaine Hydrochloride
0.25% 30 mL (75 mg) prior to surgery
Lidocaine HCl
1.5% 12 mL at the end of surgery
Celecoxib
200 mg PO bid each day postoperative
Acetaminophen Oral
1 g postoperative
Lidocaine Hydrochloride
2% 15 mL at the end of surgery
Exparel
Bupivacaine liposome injection suspension
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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 ≤ 36 kg/m2
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 study medications.
4. Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
5. Have positive results on the alcohol test (breath or saliva) or urine drug screen.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Concentric Analgesics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nancy Wu
Role: STUDY_DIRECTOR
Concentric Analgesics
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lotus Clinical Research, LLC
Pasadena, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CA-PS-205
Identifier Type: -
Identifier Source: org_study_id