Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

NCT03599089 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CA-PS-201
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 3

Brief Summary

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating a single dose of one of three CA-008 dose levels vs. placebo injected during an elective bunionectomy Bunionectomy to assess post-surgical pain management and the need for rescue medication (oxycodone).

Conditions

Post-surgical Pain

Outcome Measures

Primary Outcomes (1)

• Change in Postsurgical Pain Based on the Weighted Sum of Pain Intensity (SPI) Assessments Over 96 Hours of the NRS Scores = Area Under the Curve (AUC)

  Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) weighted sum of pain intensity scores (at rest) from 0-10 where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. The time was collected 0 to 96 hours post-dose

  [time frame: 96 hours]

Secondary Outcomes (2)

• Percentage of Subjects Opioid Free

  [time frame: 96 hours]

• Total Opioid Consumption (in Daily Morphine Equivalents)

  [time frame: 96 hours]

Study Arms (4)

CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration)

ACTIVE COMPARATOR

Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.

Drug: CA-008; Drug: Ketorolac; Drug: Acetaminophen; Drug: Oxycodone; Drug: Bupivacaine Hydrochloride

CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration)

ACTIVE COMPARATOR

Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.

Drug: CA-008; Drug: Ketorolac; Drug: Acetaminophen; Drug: Oxycodone; Drug: Bupivacaine Hydrochloride

CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration)

ACTIVE COMPARATOR

Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.

Drug: CA-008; Drug: Ketorolac; Drug: Acetaminophen; Drug: Oxycodone; Drug: Bupivacaine Hydrochloride

Placebo

PLACEBO COMPARATOR

Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.

Drug: Placebo; Drug: Ketorolac; Drug: Acetaminophen; Drug: Oxycodone; Drug: Bupivacaine Hydrochloride

Interventions

CA-008 DRUG

single-dose wound infiltration prior to surgical incision closure

Also known as: Vocacapsaicin

CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration); CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration); CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration)

Placebo DRUG

single-dose wound infiltration prior to surgical incision closure

Placebo

Ketorolac DRUG

30mg IV administered intraoperatively

CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration); CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration); CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration); Placebo

Acetaminophen DRUG

1000mg IV administered intraoperatively

CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration); CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration); CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration); Placebo

Oxycodone DRUG

5mg PO prn post-surgery

CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration); CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration); CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration); Placebo

Bupivacaine Hydrochloride DRUG

0.5% infiltration pre-surgery

CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration); CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration); CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration); Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult aged 18 - 75 years old
• American Society of Anesthesiology (ASA) physical Class 1, 2 or 3
• Planning elective Bunionectomy repair
• For both males and females: using an acceptable method of birth control
• If a female: not pregnant or breastfeeding
• Have a body mass index ≤ 40 kg/m2.
• Be willing and able to sign the informed consent form (ICF)
• Be able to complete study procedures and pain scales and to communicate meaningfully in English
• Be willing to undergo 17 blood draws for pharmacokinetic (PK )assessments over 24 hours

You may not qualify if:

• Have another painful condition, other than bunion-related pain, that may require pain treatment during the study period
• Have active skin disease or another abnormality at the anticipated site of surgery that could interfere with the planned surgery.
• Have a known allergy to chili peppers, capsaicin or the components of CA-008, bupivacaine HCl, ketorolac, acetaminophen or oxycodone.
• Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
• Be on any medication not allowed per the protocol
• Within the past year have a history of illicit drug use or prescription medicine or alcohol abuse
• Have positive results on the alcohol test (breath or saliva) or urine drug screen
• Have previously participated in a clinical study with CA-008.
• Have participated in another clinical trial or used an investigational product within 30 days or five half-lives (whichever is longer)

Sponsors & Collaborators

• Concentric Analgesics: lead

Study Sites (3)

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

Location

Chesapeake Research Group

Pasadena, Maryland, 21122, United States

Location

HD Research Corp

Houston, Texas, 77004, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketorolac; Acetaminophen; Oxycodone; Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

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

nancy@concentricanalgesics.com

14154847921

Study Officials

• Nancy Wu

  Concentric Analgesics

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 26, 2018
• Study Start: July 9, 2018
• Primary Completion: October 10, 2018
• Study Completion: October 23, 2018
• Last Updated: August 11, 2021
• Results First Posted: August 11, 2021

Record last verified: 2021-07

Locations

US (3)