Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Phase 2, single center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 vs. placebo in subjects undergoing an elective C-ABD under general anesthesia supplemented with a bupivacaine hydrochloride (HCl)transverse abdominis plane (TAP) block.
This is a Phase 2, single-center, randomized, double-blind, placebo-controlled, parallel design study evaluating up to 4 ascending dose level cohorts, each evaluating a single dose of CA-008 vs. placebo injected/instilled during an elective C-ABD. Up to 72 subjects may be randomized in 4 cohorts.
For each subject, postsurgical assessments will be conducted in two parts:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CA-008 5 mg (0.05 mg/mL) Cohort 1 | Active Comparator | Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). |
|
| Placebo for Cohort 1 | Placebo Comparator | Cohort 1: Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator. The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). |
|
| CA-008 10 mg (0.1 mg/mL) | Active Comparator | Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CA-008 5 mg | Drug | 5 mg CA-008 reconstituted in saline. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Scores at 96 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 96 hours | 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS Scores | 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) from 0 to T96 hours | 0 to 96 hours |
| Time to Opioid Cessation or Freedom |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
In the opinion of the Investigator, have a concurrent painful condition that may require analgesic treatment during the study period or may confound post-surgical pain assessments.
Have a known allergy to chili peppers, capsaicin or the components of CA-008, acetaminophen, bupivacaine, fentanyl hydromorphone or oxycodone.
As determined by the investigator have a history or clinical manifestation of significant medical, neuropsychiatric or other condition, including a clinically significant existing arrhythmia, left bundle branch block or abnormal ECG, myocardial infarction or coronary arterial bypass graft surgery within the prior 12 months, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation or interfere with study assessments.
The following are considered disallowed medications:
i. These drugs are permitted if prescribed for non-pain indications and the dose has been stable for at least 30 days prior to surgery.
ii. The use of benzodiazepines and the non-benzodiazepines are permitted to treat insomnia during the postoperative period.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alina Beaton, MD | Lotus Clinical Research, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Clinical Research, LLC | Pasadena | California | 91105 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CA-008 5 mg (0.05 mg/mL) Cohort 1 | Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). CA-008 5 mg: 5 mg CA-008 reconstituted in saline. Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery |
| FG001 | Placebo for Cohort 1 | Cohort 1: the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Placebo: Each cohort will use placebo reconstituted in saline. Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery |
| FG002 | CA-008 10 mg (0.1 mg/mL) Cohort 2 | Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery CA-008 10 mg: 10 mg CA-008 reconstituted in saline. |
| FG003 | CA-008 15 mg (0.15 mg/mL) Cohort 3 | Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery CA-008 15 mg: 15 mg CA-008 reconstituted in saline. |
| FG004 | Placebo for Cohorts 2 and 3 | Cohorts 2 & 3: the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Placebo: Each cohort will use placebo reconstituted in saline. Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CA-008 5 mg (0.05 mg/mL) Cohort 1 | Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). CA-008 5 mg: 5 mg CA-008 Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery |
| 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 | Pain Intensity Scores at 96 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 96 hours | Safety population | Posted | Mean | Standard Deviation | score on a scale | 96 hours |
|
Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline)
Not provided
Not provided
| 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 5 mg (0.05 mg/mL) Cohort 1 | Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). CA-008 5 mg: 5 mg CA-008 reconstituted in saline. Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Operations | Concentric Analgesics | 14154847921 | nancy@concentricanalgesics.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 28, 2019 | Jun 18, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 24, 2019 | Jun 22, 2021 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D004091 | Hydromorphone |
| D005283 | Fentanyl |
| D000082 | Acetaminophen |
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CA-008 15 mg (0.15 mg/mL) | Active Comparator | Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). |
|
| Placebo for Cohorts 2 and 3 | Placebo Comparator | Cohorts 2 & 3: Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator. The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). |
|
| Placebo | Drug | Each cohort will use placebo reconstituted in saline. |
|
| Bupivacaine Hydrochloride | Drug | 0.25% administered pre-surgery |
|
| Hydromorphone | Drug | 0.02 mg/kg IV administered intraoperatively |
|
| Fentanyl | Drug | 100 mcg IV administered intraoperatively |
|
| Acetaminophen | Drug | 1000 mg IV administered intraoperatively |
|
| Oxycodone | Drug | 5-10 mg PO administered post-surgery |
|
| CA-008 10 mg | Drug | 10 mg CA-008 reconstituted in saline. |
|
|
| CA-008 15 mg | Drug | 15 mg CA-008 reconstituted in saline. |
|
|
Time to the last use of opioid |
| From Surgery to Day 29 |
| Percent of Opioid Free Subjects | Percent of subjects who were opioid free at 24-96 hours | 24 to 96 hours |
| Total Opioid Consumption | The sum of daily opioid consumption (in morphine equivalents) | 0 to 96 hours |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG001 | Placebo for Cohort 1 | Cohort 1: Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active. The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Placebo: Each cohort will use placebo reconstituted in saline. Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery |
| BG002 | CA-008 10 mg (0.1 mg/mL) | Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery CA-008 10 mg: 10 mg CA-008 |
| BG003 | CA-008 15 mg (0.15 mg/mL) | Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery CA-008 15 mg: 15 mg CA-008 |
| BG004 | Placebo for Cohorts 2 and 3 | Cohorts 2 & 3: Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active. The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Placebo: Each cohort will use placebo reconstituted in saline. Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery |
| BG005 | 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 | Count of Participants | Participants |
|
| OG001 | Placebo for Cohort 1 | Cohort 1: Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator. The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Placebo: Each cohort will use placebo reconstituted in saline. Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery |
| OG002 | CA-008 10 mg (0.1 mg/mL) | Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery CA-008 10 mg: 10 mg CA-008 reconstituted in saline. |
| OG003 | CA-008 15 mg (0.15 mg/mL) | Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery CA-008 15 mg: 15 mg CA-008 reconstituted in saline. |
| OG004 | Placebo for Cohorts 2 and 3 | Cohorts 2 & 3: Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator. The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Placebo: Each cohort will use placebo reconstituted in saline. Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery |
|
|
|
| Secondary | Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS Scores | 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) from 0 to T96 hours | Safety population | Posted | Mean | Standard Deviation | score on a scale*hours | 0 to 96 hours |
|
|
|
|
| Secondary | Time to Opioid Cessation or Freedom | Time to the last use of opioid | Safety population | Posted | Median | Full Range | hours | From Surgery to Day 29 |
|
|
|
|
| Secondary | Percent of Opioid Free Subjects | Percent of subjects who were opioid free at 24-96 hours | Safety population | Posted | Count of Participants | Participants | 24 to 96 hours |
|
|
|
|
| Secondary | Total Opioid Consumption | The sum of daily opioid consumption (in morphine equivalents) | Safety population | Posted | Mean | Standard Deviation | mg morphine equivalents | 0 to 96 hours |
|
|
|
|
| 0 |
| 9 |
| 2 |
| 9 |
| 9 |
| 9 |
| EG001 | Placebo for Cohort 1 | Cohort 1: Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator. The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Placebo: Each cohort will use placebo reconstituted in saline. Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery | 0 | 9 | 0 | 9 | 8 | 9 |
| EG002 | CA-008 10 mg (0.1 mg/mL) | Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery CA-008 10 mg: 10 mg CA-008 reconstituted in saline. | 0 | 12 | 1 | 12 | 11 | 12 |
| EG003 | CA-008 15 mg (0.15 mg/mL) | Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery CA-008 15 mg: 15 mg CA-008 reconstituted in saline. | 0 | 12 | 1 | 12 | 10 | 12 |
| EG004 | Placebo for Cohorts 2 and 3 | Cohorts 2 & 3: Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator. The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Placebo: Each cohort will use placebo reconstituted in saline. Bupivacaine Hydrochloride: 0.25% administered pre-surgery Hydromorphone: 0.02 mg/kg IV administered intraoperatively Fentanyl: 100 mcg IV administered intraoperatively Acetaminophen: 1000 mg IV administered intraoperatively Oxycodone: 5-10 mg PO administered post-surgery | 0 | 12 | 0 | 12 | 11 | 12 |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 21.0 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Lip oedema | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Incision site cellulitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Airway complication of anaesthesia | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Flap necrosis | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Incision site pruritus | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Transaminases increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 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 |
|
| Sciatica | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 21.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Pruritus generalized | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D000083 | Acetanilides |
| D003061 | Codeine |