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Study in Subjects Undergoing Complete Abdominoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789318
Recruitment Status : Completed
First Posted : December 28, 2018
Results First Posted : January 13, 2022
Last Update Posted : March 19, 2024
Sponsor:
Information provided by (Responsible Party):
Concentric Analgesics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Postsurgical Pain Drug: CA-008 5 mg Drug: Placebo Drug: Bupivacaine Hydrochloride Drug: Hydromorphone Drug: Fentanyl Drug: Acetaminophen Drug: Oxycodone Drug: CA-008 10 mg Drug: CA-008 15 mg Phase 2

Detailed Description:

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:

  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Placebo-Controlled Efficacy, Pharmacokinetics and Safety Study of CA-008 in Subjects Undergoing Complete Abdominoplasty
Actual Study Start Date : December 3, 2018
Actual Primary Completion Date : May 16, 2019
Actual Study Completion Date : June 12, 2019

Arm Intervention/treatment
Active Comparator: 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).
Drug: CA-008 5 mg
5 mg CA-008 reconstituted in saline.
Other Name: Vocacapsaicin

Drug: Bupivacaine Hydrochloride
0.25% administered pre-surgery

Drug: Hydromorphone
0.02 mg/kg IV administered intraoperatively

Drug: Fentanyl
100 mcg IV administered intraoperatively

Drug: Acetaminophen
1000 mg IV administered intraoperatively

Drug: Oxycodone
5-10 mg PO administered post-surgery

Placebo Comparator: 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).

Drug: Placebo
Each cohort will use placebo reconstituted in saline.

Drug: Bupivacaine Hydrochloride
0.25% administered pre-surgery

Drug: Hydromorphone
0.02 mg/kg IV administered intraoperatively

Drug: Fentanyl
100 mcg IV administered intraoperatively

Drug: Acetaminophen
1000 mg IV administered intraoperatively

Drug: Oxycodone
5-10 mg PO administered post-surgery

Active Comparator: 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).
Drug: Bupivacaine Hydrochloride
0.25% administered pre-surgery

Drug: Hydromorphone
0.02 mg/kg IV administered intraoperatively

Drug: Fentanyl
100 mcg IV administered intraoperatively

Drug: Acetaminophen
1000 mg IV administered intraoperatively

Drug: Oxycodone
5-10 mg PO administered post-surgery

Drug: CA-008 10 mg
10 mg CA-008 reconstituted in saline.
Other Name: Vocacapsaicin

Active Comparator: 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).
Drug: Bupivacaine Hydrochloride
0.25% administered pre-surgery

Drug: Hydromorphone
0.02 mg/kg IV administered intraoperatively

Drug: Fentanyl
100 mcg IV administered intraoperatively

Drug: Acetaminophen
1000 mg IV administered intraoperatively

Drug: Oxycodone
5-10 mg PO administered post-surgery

Drug: CA-008 15 mg
15 mg CA-008 reconstituted in saline.
Other Name: Vocacapsaicin

Placebo Comparator: 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).

Drug: Placebo
Each cohort will use placebo reconstituted in saline.

Drug: Bupivacaine Hydrochloride
0.25% administered pre-surgery

Drug: Hydromorphone
0.02 mg/kg IV administered intraoperatively

Drug: Fentanyl
100 mcg IV administered intraoperatively

Drug: Acetaminophen
1000 mg IV administered intraoperatively

Drug: Oxycodone
5-10 mg PO administered post-surgery




Primary Outcome Measures :
  1. Pain Intensity Scores at 96 Hours at Rest Using Numerical Rating Scale (NRS) [ Time Frame: 96 hours ]
    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


Secondary Outcome Measures :
  1. Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS Scores [ Time Frame: 0 to 96 hours ]
    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

  2. Time to Opioid Cessation or Freedom [ Time Frame: From Surgery to Day 29 ]
    Time to the last use of opioid

  3. Percent of Opioid Free Subjects [ Time Frame: 24 to 96 hours ]
    Percent of subjects who were opioid free at 24-96 hours

  4. Total Opioid Consumption [ Time Frame: 0 to 96 hours ]
    The sum of daily opioid consumption (in morphine equivalents)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Plan to undergo an elective complete abdominoplasty (C-ABD), without collateral procedure or additional surgeries.
  • 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).

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:

    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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789318


Locations
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United States, California
Lotus Clinical Research, LLC
Pasadena, California, United States, 91105
Sponsors and Collaborators
Concentric Analgesics
Investigators
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Principal Investigator: Alina Beaton, MD Lotus Clinical Research, LLC
  Study Documents (Full-Text)

Documents provided by Concentric Analgesics:
Study Protocol  [PDF] January 28, 2019
Statistical Analysis Plan  [PDF] April 24, 2019

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Responsible Party: Concentric Analgesics
ClinicalTrials.gov Identifier: NCT03789318    
Other Study ID Numbers: CA-PS-204
First Posted: December 28, 2018    Key Record Dates
Results First Posted: January 13, 2022
Last Update Posted: March 19, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Acetaminophen
Fentanyl
Oxycodone
Hydromorphone
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Antipyretics