At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 36 enrolled
Drug / intervention
CA-008 +9 moredrug
Likely dose
CA-008 4.2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-Label Study of Intraoperative CA-008 Administration in Subjects Undergoing Bunionectomy
In Brief
A Phase 2 clinical trial evaluating CA-008, Ketorolac, and 8 other interventions for Pain. Completed, enrolled 36 participants across 1 site.
Detailed Summary
A Phase 2, open-label study of CA-008 to evaluate post-surgical pain control with CA-008.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
First PostedMar 2019
Enrollment StartMar 2019
Primary CompletionJul 2019
Study CompletionOct 2019
TodayJul 2026
First PostedMar 21, 2019
Enrollment StartMar 25, 2019
Primary CompletionJul 2, 2019
Study CompletionOct 22, 2019
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 7.3 years ago
Interventions
CA-008drug
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