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

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: NCT04203537
Recruitment Status : Completed
First Posted : December 18, 2019
Results First Posted : January 12, 2022
Last Update Posted : January 12, 2022
Sponsor:
Information provided by (Responsible Party):
Concentric Analgesics

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.

Condition or disease Intervention/treatment Phase
Postsurgical Pain Drug: CA-008 Drug: Placebo Phase 1 Phase 2

Detailed Description:
Not provided

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Part A: dose ascending, placebo-controlled Part B: randomized, double-blind, placebo-controlled, parallel design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 4, 2019
Actual Primary Completion Date : October 26, 2020
Actual Study Completion Date : October 26, 2020

Arm Intervention/treatment
Active Comparator: CA-008 36 mg
Single administration (0.3 mg/mL concentration)
Drug: CA-008
Local administration during surgery
Other Name: vocacapsaicin

Active Comparator: CA-008 60 mg
Single administration (0.5 mg/mL concentration)
Drug: CA-008
Local administration during surgery
Other Name: vocacapsaicin

Active Comparator: CA-008 90 mg
Single administration (0.75 mg/mL concentration)
Drug: CA-008
Local administration during surgery
Other Name: vocacapsaicin

Placebo Comparator: Placebo
Single administration
Drug: Placebo
Local administration during surgery




Primary Outcome Measures :
  1. Pain Intensity Scores [ Time Frame: 0 to 192 hours post dose ]
    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 :
  1. Total Opioid Consumption [ Time Frame: 0 to Day 15 post dose ]
    CA-008 versus placebo comparison, total opioid consumption in oral morphine equivalents



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04203537


Locations
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United States, California
Lotus Clinical Reserach, LLC
Pasadena, California, United States, 91105
United States, Texas
Legent Orthopedic Hospital
Carrollton, Texas, United States, 75006
First Surgical Hospital
Houston, Texas, United States, 77401
Plano Surgical Hospital
Plano, Texas, United States, 75093
Sponsors and Collaborators
Concentric Analgesics
Investigators
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Principal Investigator: Daneshvari Solanki, MD HD Research
  Study Documents (Full-Text)

Documents provided by Concentric Analgesics:
Study Protocol  [PDF] April 22, 2020
Statistical Analysis Plan  [PDF] November 12, 2020

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Responsible Party: Concentric Analgesics
ClinicalTrials.gov Identifier: NCT04203537    
Other Study ID Numbers: CA-PS-208
First Posted: December 18, 2019    Key Record Dates
Results First Posted: January 12, 2022
Last Update Posted: January 12, 2022
Last Verified: December 2021
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