Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2018-12-03
2019-06-12
Brief Summary
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Detailed Description
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For each subject, postsurgical assessments will be conducted in two parts:
* Inpatient period: starts with completion of study treatment injection (T0) and continues through 96 hours (T96h).
* Outpatient period: begins on discharge from the inpatient unit through various follow up visits to day 29 (D29)/week 4 (W4) after surgery. Note that additional follow up visits may occur at any time or even after D29/W4 to follow adverse events (AEs) to resolution or establishment of a new baseline.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
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
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.
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.
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
Interventions
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CA-008 5 mg
5 mg CA-008 reconstituted in saline.
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
CA-008 10 mg
10 mg CA-008 reconstituted in saline.
CA-008 15 mg
15 mg CA-008 reconstituted in saline.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In the medical judgment of the investigator, be a reasonably healthy adult aged 18 - 65 years old, inclusive, and American Society of Anesthesiology (ASA) physical Class 1 or 2 at the time of randomization.
* Unless the subject has a same sex partner, he or she must either be sterile (surgically or biologically) or commit to an acceptable method of birth control while participating in the study.
* Have a body mass index ≤ 35 kg/m².
* Be willing and able to sign the informed consent form (ICF) approved by an Institutional Review Board (IRB).
Exclusion Criteria
* 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:
1. Be tolerant to opioids defined as those who have been receiving or have received chronic opioid therapy greater than 15 mg of oral morphine equivalents per day for greater than 3 out of 7 days per week over a one-month period within 6 months of screening.
2. Within 1 day prior to surgery and throughout the inpatient period, be taking any capsaicin-containing products, such as dietary supplements or over-the-counter (OTC) preparations, including topical formulations, and prescription medications.
3. Within the 7 days prior to surgery, be taking any central nervous system (CNS) active agent as an analgesic adjunct medication, such as anticonvulsants, antidepressants, benzodiazepines, sedative- hypnotics, clonidine and other central alpha-2 agents, ketamine or muscle relaxants.
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.
18 Years
65 Years
ALL
No
Sponsors
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Concentric Analgesics
INDUSTRY
Responsible Party
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Principal Investigators
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Alina Beaton, MD
Role: PRINCIPAL_INVESTIGATOR
Lotus Clinical Research, LLC
Locations
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Lotus Clinical Research, LLC
Pasadena, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CA-PS-204
Identifier Type: -
Identifier Source: org_study_id
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