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CompletedNCT04203537Updated May 8, 2024Results posted

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

A Phase 1/2 interventional study of CA-008 and Placebo in Postsurgical Pain, sponsored by Concentric Analgesics. Completed at 4 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-08.

Sponsored by Concentric Analgesics · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
193
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

Not provided

02

Conditions studied

  • Postsurgical Pain

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03

In context

Pain, Postoperative

5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.

This study's enrollment of 193 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Concentric Analgesics is the lead sponsor of 7 studies on the registry; none are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 7 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Concurrent condition requiring analgesic treatment during study period
  • Opioid tolerant
  • Known allergy to capsaicin or other study medication
  • Use of prohibited medications
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
193 participants (actual)

Study arms

  • Active comparator
    CA-008 36 mg

    Single administration (0.3 mg/mL concentration)

    Drug: CA-008

  • Active comparator
    CA-008 60 mg

    Single administration (0.5 mg/mL concentration)

    Drug: CA-008

  • Active comparator
    CA-008 90 mg

    Single administration (0.75 mg/mL concentration)

    Drug: CA-008

  • Placebo comparator
    Placebo

    Single administration

    Drug: Placebo

Interventions

  • DrugCA-008

    Local administration during surgery

    Also known as: vocacapsaicin

  • DrugPlacebo

    Local administration during surgery

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 0 to Day 15 post dose

Secondary outcomes

  1. Total Opioid Consumption

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

    Time frame: 0 to Day 15 post dose

07

Results

Posted Jan 12, 2022

Participant flow

Part A consisted of 3 small, sequential, placebo-controlled, dose-escalation cohorts evaluating 36, 60 and 90 mg for safety. Part B evaluated 36 and 60 mg compared to placebo in parallel, randomized groups. Efficacy data from Part A remained blinded until the end of Part B and these data were pooled for analysis.

Participant flow — Overall Study
MilestoneCA-008 36 mg (Patients From Part A)CA-008 60 mg (Patients From Part A)CA-008 90 mg (Patients From Part A)Placebo (Patients From Part A)CA-008 36 mg (Patients From Part B)CA-008 60 mg (Patients From Part B)Placebo (Patients From Part B)
Started6666545560
Completed6666545560
Not completed0000000

Outcome measures

PrimaryPain 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

Time frame:
0 to Day 15 post dose
Reported as:
Mean · scores on a scale*hours
Pain Intensity Scores
scores on a scale*hoursCA-008 36 mg (0.3 mg/mL Concentration)CA-008 60 mg (0.5 mg/mL Concentration)CA-008 90 mg (0.75 mg/mL Concentration)Placebo
AUC 12-96 hour367.41 ± 137.561415.27 ± 140.967373.92 ± 175.834447.05 ± 108.596
AUC 0-96 hour397.68 ± 152.002448.02 ± 155.948403.08 ± 172.515481.97 ± 120.535
AUC 0-Day 151235.36 ± 608.2591530.93 ± 571.3371629.97 ± 437.9511452.08 ± 493.622
Statistical analysis
  • CA-008 36 mg (0.3 mg/mL Concentration) vs Placebo · ANOVA · p = 0.0004
SecondaryTotal Opioid Consumption

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

Time frame:
0 to Day 15 post dose
Reported as:
Mean · mg morphine equivalents
Total Opioid Consumption
mg morphine equivalentsCA-008 36 mg (0.3 mg/mL Concentration)CA-008 60 mg (0.5 mg/mL Concentration)CA-008 90 mg (0.75 mg/mL Concentration)Placebo
OC12-96 hours141.37 ± 75.98165.92 ± 81.48151.04 ± 70.59206.26 ± 82.11
OC0-96 hours154.795 ± 85.95183.74 ± 89.74177.29 ± 66.67219.94 ± 88.19
OC 0- Day 15206.04 ± 132.99275.07 ± 155.14263.54 ± 138.11319.12 ± 164.62
Statistical analysis
  • CA-008 36 mg (0.3 mg/mL Concentration) vs Placebo · ANOVA · p = <0.0001
  • CA-008 60 mg (0.5 mg/mL Concentration) vs Placebo · ANOVA · p = 0.0026

Adverse events

Collected over Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CA-008 36 mg0/60 (0%)2/60 (3.3%)54/60 (90%)
CA-008 60 mg0/61 (0%)1/61 (1.6%)58/61 (95.1%)
CA-008 90 mg0/6 (0%)0/6 (0%)6/6 (100%)
Placebo0/66 (0%)2/66 (3%)66/66 (100%)
Most frequent serious events
Most frequent serious events
EventCA-008 36 mgCA-008 60 mgCA-008 90 mgPlacebo
Myocardial InfarctionCardiac disorders1/600/610/60/66
Post procedural haematomaInjury, poisoning and procedural complications1/600/610/61/66
Drug hypersensitivityImmune system disorders0/601/610/60/66
Pulmonary embolismRespiratory, thoracic and mediastinal disorders0/600/610/61/66
Most frequent other events
Showing 10 of 99
Most frequent other events
EventCA-008 36 mgCA-008 60 mgCA-008 90 mgPlacebo
NauseaGastrointestinal disorders24/6028/615/636/66
ConstipationGastrointestinal disorders29/6032/614/630/66
TachycardiaCardiac disorders13/6017/613/612/66
PyrexiaGeneral disorders12/6010/612/64/66
DizzinessNervous system disorders8/602/612/67/66
PruritusSkin and subcutaneous tissue disorders8/609/612/610/66
VomitingGastrointestinal disorders9/6011/611/615/66
Drug ineffectiveGeneral disorders3/603/611/67/66
Pain in extremityMusculoskeletal and connective tissue disorders5/605/611/65/66
HypoxiaRespiratory, thoracic and mediastinal disorders3/604/611/64/66

Baseline characteristics

1 subject was randomized to CA-008 60 mg, but actually received placebo 1 subject was randomized to CA-008 36 mg, but actually received placebo Both subjects are included in the placebo arm

Age, Continuous
Age, Continuous(years)CA-008 36 mgCA-008 60 mgCA-008 90 mgPlaceboTotal
Mean63.9 ± 7.7963.1 ± 7.8265.5 ± 8.9259.7 ± 6.4562.3 ± 7.59
Sex: Female, Male
Sex: Female, Male(Participants)CA-008 36 mgCA-008 60 mgCA-008 90 mgPlaceboTotal
Female2932439104
Male312922789
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)CA-008 36 mgCA-008 60 mgCA-008 90 mgPlaceboTotal
Hispanic or Latino111601239
Not Hispanic or Latino4945554153
Unknown or Not Reported00101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)CA-008 36 mgCA-008 60 mgCA-008 90 mgPlaceboTotal
American Indian or Alaska Native01001
Asian25119
Native Hawaiian or Other Pacific Islander00000
Black or African American13100932
White4545556151
More than one race00000
Unknown or Not Reported00000
08

Study locations

4 sites
  • Lotus Clinical Reserach, LLC
    Pasadena, California 91105, United States
  • Legent Orthopedic Hospital
    Carrollton, Texas 75006, United States
  • First Surgical Hospital
    Houston, Texas 77401, United States
  • Plano Surgical Hospital
    Plano, Texas 75093, United States
09

References and documents

Study documents

  • Study protocol · Apr 22, 2020
  • Statistical analysis plan · Nov 12, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2019 to primary completion in Oct 2020, 10 months.

Results were first posted in Jan 2022, 1 year 2 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2019
First posted
Dec 18, 2019
StartActual
Dec 4, 2019
Primary completionActual
Oct 26, 2020
CompletionActual
Oct 26, 2020
Results first posted
Jan 12, 2022
Last update
May 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04203537
Lead sponsor
Concentric Analgesics
Responsible party
Sponsor
First posted
Dec 18, 2019
Start date
Dec 4, 2019
Primary completion
Oct 26, 2020
Completion
Oct 26, 2020
Results posted
Jan 12, 2022
Last update
May 8, 2024

Study contacts

Daneshvari Solanki, MD
principal investigator · HD Research

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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