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Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)

Primary Purpose

Postsurgical Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CA-008
Placebo
Sponsored by
Concentric Analgesics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postsurgical Pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Scheduled elective Total Knee Arthroplasty (TKA) under spinal anesthesia
  • Aged 18-80 years old
  • ASA physical class 1, 2, or 3
  • BMI </= 42 kg/m2
  • Generally healthy

Exclusion Criteria:

  • Concurrent condition requiring analgesic treatment during study period
  • Opioid tolerant
  • Known allergy to capsaicin or other study medication
  • Use of prohibited medications

Sites / Locations

  • Lotus Clinical Reserach, LLC
  • Legent Orthopedic Hospital
  • First Surgical Hospital
  • Plano Surgical Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

CA-008 36 mg

CA-008 60 mg

CA-008 90 mg

Placebo

Arm Description

Single administration (0.3 mg/mL concentration)

Single administration (0.5 mg/mL concentration)

Single administration (0.75 mg/mL concentration)

Single administration

Outcomes

Primary Outcome Measures

Pain Intensity Scores
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. AUC is calculated using the standard trapezoidal rule from serial measures of NRS taken every 4 hours from 0-96 hours following surgery and twice daily from 96h to Day 15

Secondary Outcome Measures

Total Opioid Consumption
CA-008 versus placebo comparison, total opioid consumption in oral morphine equivalents

Full Information

First Posted
December 16, 2019
Last Updated
December 17, 2021
Sponsor
Concentric Analgesics
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1. Study Identification

Unique Protocol Identification Number
NCT04203537
Brief Title
Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)
Official Title
A Two-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics and Preliminary Efficacy Study of CA-008 in Patients Undergoing Total Knee Arthroplasy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 4, 2019 (Actual)
Primary Completion Date
October 26, 2020 (Actual)
Study Completion Date
October 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Concentric Analgesics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In the pilot (Part A) of this study, multiple doses of CA-008 (vocacapsaicin) were evaluated for safety, tolerability, and PK. Doses were then selected for the expanded part (Part B) of the study, where CA-008 was compared to placebo. Patients had serial assessments of safety, PK, and drug effect.
Detailed Description
Not provided

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postsurgical Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Part A: dose ascending, placebo-controlled Part B: randomized, double-blind, placebo-controlled, parallel design
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CA-008 36 mg
Arm Type
Active Comparator
Arm Description
Single administration (0.3 mg/mL concentration)
Arm Title
CA-008 60 mg
Arm Type
Active Comparator
Arm Description
Single administration (0.5 mg/mL concentration)
Arm Title
CA-008 90 mg
Arm Type
Active Comparator
Arm Description
Single administration (0.75 mg/mL concentration)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single administration
Intervention Type
Drug
Intervention Name(s)
CA-008
Other Intervention Name(s)
vocacapsaicin
Intervention Description
Local administration during surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Local administration during surgery
Primary Outcome Measure Information:
Title
Pain Intensity Scores
Description
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. AUC is calculated using the standard trapezoidal rule from serial measures of NRS taken every 4 hours from 0-96 hours following surgery and twice daily from 96h to Day 15
Time Frame
0 to 192 hours post dose
Secondary Outcome Measure Information:
Title
Total Opioid Consumption
Description
CA-008 versus placebo comparison, total opioid consumption in oral morphine equivalents
Time Frame
0 to Day 15 post dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled elective Total Knee Arthroplasty (TKA) under spinal anesthesia Aged 18-80 years old ASA physical class 1, 2, or 3 BMI </= 42 kg/m2 Generally healthy Exclusion Criteria: Concurrent condition requiring analgesic treatment during study period Opioid tolerant Known allergy to capsaicin or other study medication Use of prohibited medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daneshvari Solanki, MD
Organizational Affiliation
HD Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lotus Clinical Reserach, LLC
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Legent Orthopedic Hospital
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
Facility Name
First Surgical Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Plano Surgical Hospital
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)

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