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A Phase 2, open-label study of CA-008 to evaluate post-surgical pain control with CA-008.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| CA-008 Cohort 2 | Experimental | CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block. |
|
| CA-008 Cohort 3 | Experimental | CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CA-008 | Drug | Drug: CA-008 4.2 mg reconstituted in saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Summary of opioid consumption in oral morphine equivalents | 0-72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Wu | Concentric Analgesics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Clinical Research, LLC | Pasadena | California | 91105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | CA-008 Cohort 1 | CA-008 4.2 mg 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 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 |
| FG001 | CA-008 Cohort 2 | CA-008 4.2 mg All subjects received monitored anesthesia care (MAC) and a Mayo block. CA-008: Drug: CA-008 4.2 mg 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 |
| FG002 | CA-008 Cohort 3 | CA-008 4.2 mg All subjects received monitored anesthesia care (MAC) and a Mayo block. CA-008: Drug: CA-008 4.2 mg 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 |
| FG003 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CA-008 (Vocacapsaicin) 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Safety population | Posted | Mean | Standard Deviation | score on a scale*hour | 0-72 hours |
|
Up to 76 days: Screening period from 45 days prior to surgery (D-45) to D29±2 Study Completion Visit. Unscheduled visits or visits after D29 might be necessary to assess ongoing safety issues or to follow an event to resolution or to establishment of a new baseline.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Operations | Concentric Analgesics | 14154847921 | nancy@concentricanalgesics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 2, 2019 | Jul 6, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 5, 2019 | Jul 6, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D005283 | Fentanyl |
| D002045 | Bupivacaine |
| D008012 | Lidocaine |
| D000068579 | Celecoxib |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Ketorolac | Drug | 30 mg IV at the onset of anesthesia |
|
| Acetaminophen IV | Drug | 1 g at the onset of anesthesia |
|
| Fentanyl | Drug | 100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery |
|
| Bupivacaine Hydrochloride | Drug | 0.25% 30 mL (75 mg) prior to surgery |
|
| Lidocaine HCl | Drug | 1.5% 12 mL at the end of surgery |
|
| Celecoxib | Drug | 200 mg PO bid each day postoperative |
|
| Acetaminophen Oral | Drug | 1 g postoperative |
|
| Lidocaine Hydrochloride | Drug | 2% 15 mL at the end of surgery |
|
| Exparel | Drug | Bupivacaine liposome injection suspension |
|
| BG001 | CA-008 (Vocacapsaicin) 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 |
| BG002 | CA-008 (Vocacapsaicin) 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
| OG002 | 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 |
| OG003 | 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 |
|
|
| Secondary | Opioid Consumption | Summary of opioid consumption in oral morphine equivalents | Safety population | Posted | Mean | Standard Deviation | mg morphine equivalents | 0-72 hours |
|
|
|
| Primary | 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 | Safety population | Posted | Mean | Standard Deviation | units on a scale | 24 hours |
|
|
|
| Primary | 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 | Safety population | Posted | Mean | Standard Deviation | score on a scale | 48 hours |
|
|
|
| Primary | 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 | Safety population | Posted | Mean | Standard Deviation | score on a scale | 72 hours |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | 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 | 0 | 9 | 0 | 9 | 4 | 9 |
| EG002 | 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 | 0 | 9 | 0 | 9 | 5 | 9 |
| EG003 | 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 | 0 | 9 | 0 | 9 | 5 | 9 |
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
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| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000083 | Acetanilides |
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011720 | Pyrazoles |
| D001393 | Azoles |