Study in Subjects Undergoing Complete Abdominoplasty

NCT03789318 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CA-PS-204
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Postsurgical Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS Scores

  0 to 96 hours

• Time to Opioid Cessation or Freedom

  From Surgery to Day 29

• Percent of Opioid Free Subjects

  24 to 96 hours

• Total Opioid Consumption

  0 to 96 hours

Study Arms (5)

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).

Drug: CA-008 5 mg; Drug: Bupivacaine Hydrochloride; Drug: Hydromorphone; Drug: Fentanyl; Drug: Acetaminophen; Drug: Oxycodone

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).

Drug: Placebo; Drug: Bupivacaine Hydrochloride; Drug: Hydromorphone; Drug: Fentanyl; Drug: Acetaminophen; Drug: Oxycodone

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).

Drug: Bupivacaine Hydrochloride; Drug: Hydromorphone; Drug: Fentanyl; Drug: Acetaminophen; Drug: Oxycodone; Drug: CA-008 10 mg

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).

Drug: Bupivacaine Hydrochloride; Drug: Hydromorphone; Drug: Fentanyl; Drug: Acetaminophen; Drug: Oxycodone; Drug: CA-008 15 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).

Drug: Placebo; Drug: Bupivacaine Hydrochloride; Drug: Hydromorphone; Drug: Fentanyl; Drug: Acetaminophen; Drug: Oxycodone

Interventions

CA-008 5 mg DRUG

5 mg CA-008 reconstituted in saline.

Also known as: Vocacapsaicin

CA-008 5 mg (0.05 mg/mL) Cohort 1

Placebo DRUG

Each cohort will use placebo reconstituted in saline.

Placebo for Cohort 1; Placebo for Cohorts 2 and 3

Bupivacaine Hydrochloride DRUG

0.25% administered pre-surgery

CA-008 10 mg (0.1 mg/mL); CA-008 15 mg (0.15 mg/mL); CA-008 5 mg (0.05 mg/mL) Cohort 1; Placebo for Cohort 1; Placebo for Cohorts 2 and 3

Hydromorphone DRUG

0.02 mg/kg IV administered intraoperatively

CA-008 10 mg (0.1 mg/mL); CA-008 15 mg (0.15 mg/mL); CA-008 5 mg (0.05 mg/mL) Cohort 1; Placebo for Cohort 1; Placebo for Cohorts 2 and 3

Fentanyl DRUG

100 mcg IV administered intraoperatively

CA-008 10 mg (0.1 mg/mL); CA-008 15 mg (0.15 mg/mL); CA-008 5 mg (0.05 mg/mL) Cohort 1; Placebo for Cohort 1; Placebo for Cohorts 2 and 3

Acetaminophen DRUG

1000 mg IV administered intraoperatively

CA-008 10 mg (0.1 mg/mL); CA-008 15 mg (0.15 mg/mL); CA-008 5 mg (0.05 mg/mL) Cohort 1; Placebo for Cohort 1; Placebo for Cohorts 2 and 3

Oxycodone DRUG

5-10 mg PO administered post-surgery

CA-008 10 mg (0.1 mg/mL); CA-008 15 mg (0.15 mg/mL); CA-008 5 mg (0.05 mg/mL) Cohort 1; Placebo for Cohort 1; Placebo for Cohorts 2 and 3

CA-008 10 mg DRUG

10 mg CA-008 reconstituted in saline.

Also known as: Vocacapsaicin

CA-008 10 mg (0.1 mg/mL)

CA-008 15 mg DRUG

15 mg CA-008 reconstituted in saline.

Also known as: Vocacapsaicin

CA-008 15 mg (0.15 mg/mL)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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:
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Concentric Analgesics: lead

Study Sites (1)

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Hydromorphone; Fentanyl; Acetaminophen; Oxycodone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Acetanilides; Codeine

Results Point of Contact

• Title: Head of Clinical Operations
• Organization: Concentric Analgesics

nancy@concentricanalgesics.com

14154847921

Study Officials

• Alina Beaton, MD

  Lotus Clinical Research, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2018
• First Posted: December 28, 2018
• Study Start: December 3, 2018
• Primary Completion: May 16, 2019
• Study Completion: June 12, 2019
• Last Updated: March 19, 2024
• Results First Posted: January 13, 2022

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)