Postsurgical PainPhase 2NCT03731364
Study of CA-008 (Vocacapsaicin) in Total Knee Arthroplasty
A Phase 2 study testing CA-008 in people with Postsurgical Pain, run by Concentric Analgesics at 1 site in United States.
Trial summary
This is a two-part, Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 (vocacapsaicin) vs. placebo injected/instilled during an elective TKA. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postsurgical Pain
- What is being tested?
- CA-008
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2018to 31 May 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Plan to undergo an elective primary unilateral total knee arthroplasty (TKA or knee replacement), without collateral procedure or additional surgeries.
- Be a reasonably healthy adult aged 18 - 80 years old, inclusive, with a BMI ≤ 36 kg/m2 and American Society of Anesthesiology (ASA) physical Class 1, 2 or 3 at the time of randomization.
- Males and females must abstain from intercourse, use acceptable birth control methods or be sterile or otherwise incapable of having children.
- Be willing and able to sign the informed consent form (ICF)
- Be willing and able to complete study procedures and pain scales and to communicate meaningfully in English. Be able and willing to return for outpatient follow up visits as required.
Who cannot join
- In the opinion of the Investigator,
- have a concurrent painful condition, other than pain in the knee to be replaced, that may require pain treatment during the study period.
- have active skin disease or other clinically significant 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, ropivacaine, ketorolac, acetaminophen, fentanyl, hydromorphone, morphine or oxycodone.
- Have significant medical, neuropsychiatric or other condition.
- The following are considered disallowed medications:
Show all 13Show fewer
- tolerant to opioids as defined
- capsaicin-containing products or foods.
- central nervous system active agent as an analgesic adjunct medication
- antiarrhythmics except beta-blockers, digoxin, warfarin, lithium, or aminoglycosides or other antibiotics for an infection
- parenteral or oral corticosteroids.
- antianginal, antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days or which is not expected to remain stable while participating in the study.
- Have positive results on the alcohol breath/saliva test indicative of alcohol abuse or urine drug screen indicative of illicit drug use at screening, and/or prior to surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-Controlled Efficacy, Pharmacokinetics and Safety Study of CA-008 (Vocacapsaicin) in Subjects Undergoing Total Knee Arthroplasty
This is a two-part, Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 (vocacapsaicin) vs. placebo injected/instilled during an elective TKA.
Read the detailed description
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating, in a pilot stage of the study, up to 3 ascending dose level cohorts each evaluating a single dose of CA-008 vs. placebo injected/instilled during an elective TKA. Up to 54 subjects will be randomized in the pilot stage. During the optional second stage of the study, subjects will be randomized to one of either 2 or 3 CA-008 dose levels (to be determined) or placebo. The Sponsor made the decision not to proceed with the second stage.
- Conditions
- Postsurgical Pain
- Being tested
- CA-008, Placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CA-008Drug
Also called vocacapsaicin
5 mg CA-008 (0.05 mg/mL), 10 mg CA-008 (0.1 mg/mL) and 15 mg CA-008 (0.15 mg/mL)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| CA-008 5 mg (0.05 mg/mL) Cohort 1 | Active comparator | Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008 (vocacapsaicin) Receives: Drug: CA-008 |
| Placebo - Cohort 1 | Placebo comparator | Placebo for Cohort 1
Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active Receives: Drug: Placebo |
| CA-008 10 mg (0.1 mg/mL) Cohort 2 | Active comparator | Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008 (vocacapsaicin) Receives: Drug: CA-008 |
| CA-008 15 mg (0.15 mg/mL) Cohort 3 | Active comparator | Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008 (vocacapsaicin) Receives: Drug: CA-008 |
| Placebo - Cohorts 2 and 3 | Placebo comparator | Placebo - Cohorts 2 and 3
Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-specific Mean Pain Intensity Scores (NRS) at Time 96 Hours for CA-008 vs. Placebo
Primary Efficacy Endpoint for the Pilot Stage. Time-specific mean pain intensity scores at Time 96 hours for CA-008 vs. placebo based on a 10-point numerical rating scale (NRS) from 0-10 where 0 is no pain and 10 is the worst pain imaginable).
Measured: At 96 hours
CA-008 Dose vs. Placebo Comparison: Area Under the Curve (AUC) 0 to 96 Hours
Primary Efficacy Endpoint for Stage 2. Area Under the Curve (AUC) of the NRS current pain intensity scores from Time 0 hours to 96 hours at rest (AUC0 to 96h) where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. •
During the inpatient stay, NRS at rest beginning with the PACU admission may be assessed once the subject is awake.
The maximum is an NRS score of 10 x all 96 hours = 960 NRS units*hrs; the minimum is 0 x 96h = 0 NRS units*hrs
Measured: From 0 hours to 96 hours
Secondary outcomes (2)
Percentage of Subjects Who do Not Require Opioids
Key Secondary Efficacy Endpoints for Stage 2. For each CA-008 dose vs. placebo comparison, percentage of subjects who do not require opioids.
Measured: Time 0 hours to Time 96 hours: Opioid Free 0 hours to 96 hours
Total Opioid Consumption (in Daily Oral Morphine Equivalents)
Key Secondary Efficacy Endpoints for Stage 2. Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo
Measured: OC from Time 0 hours to Time 96 hours: OC 0 hours to 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start29 Oct 2018
- Primary completion30 Apr 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postsurgical PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concentric Analgesics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daneshvari Solanki, MD, Principal investigator, First Surgical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03731364
- Sponsor's protocol ID
- CA-PS-203
- Status last verified
- Dec 2021
- First submitted
- 24 Oct 2018
- Last updated
- 15 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-Controlled Efficacy, Pharmacokinetics and Safety Study of CA-008 (Vocacapsaicin) in Subjects Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03731364
- Acronym / sponsor ID
- CA-PS-203
- Conditions
- Postsurgical Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Concentric AnalgesicsIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 6 Nov 2018 (actual)
- Results
- Posted 15 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two-part, Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 (vocacapsaicin) vs. placebo injected/instilled during an elective TKA.
Detailed description
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating, in a pilot stage of the study, up to 3 ascending dose level cohorts each evaluating a single dose of CA-008 vs. placebo injected/instilled during an elective TKA. Up to 54 subjects will be randomized in the pilot stage. During the optional second stage of the study, subjects will be randomized to one of either 2 or 3 CA-008 dose levels (to be determined) or placebo. The Sponsor made the decision not to proceed with the second stage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CA-008 5 mg (0.05 mg/mL) Cohort 1 | Active comparator | Drug: CA-008Cohort 1 (5 mg), was prepared at 0.05 mg/mL CA-008 (vocacapsaicin) |
| Placebo - Cohort 1 | Placebo comparator | Drug: PlaceboPlacebo for Cohort 1 Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active |
| CA-008 10 mg (0.1 mg/mL) Cohort 2 | Active comparator | Drug: CA-008Cohort 2 (10 mg), was prepared at 0.1 mg/mL CA-008 (vocacapsaicin) |
| CA-008 15 mg (0.15 mg/mL) Cohort 3 | Active comparator | Drug: CA-008Cohort 3 (15 mg), was prepared at 0.15 mg/mL CA-008 (vocacapsaicin) |
| Placebo - Cohorts 2 and 3 | Placebo comparator | Drug: PlaceboPlacebo - Cohorts 2 and 3 Placebo comparator identical in appearance to the investigational product, containing the same excipients as the active |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Plan to undergo an elective primary unilateral total knee arthroplasty (TKA or knee replacement), without collateral procedure or additional surgeries.
- Be a reasonably healthy adult aged 18 - 80 years old, inclusive, with a BMI ≤ 36 kg/m2 and American Society of Anesthesiology (ASA) physical Class 1, 2 or 3 at the time of randomization.
- Males and females must abstain from intercourse, use acceptable birth control methods or be sterile or otherwise incapable of having children.
- Be willing and able to sign the informed consent form (ICF)
- Be willing and able to complete study procedures and pain scales and to communicate meaningfully in English. Be able and willing to return for outpatient follow up visits as required.
Key exclusion criteria (13 listed)
- In the opinion of the Investigator,
- Have a known allergy to chili peppers, capsaicin or the components of CA-008, ropivacaine, ketorolac, acetaminophen, fentanyl, hydromorphone, morphine or oxycodone.
- Have significant medical, neuropsychiatric or other condition.
- The following are considered disallowed medications:
- Have positive results on the alcohol breath/saliva test indicative of alcohol abuse or urine drug screen indicative of illicit drug use at screening, and/or prior to surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CA-008Also: vocacapsaicin5 mg CA-008 (0.05 mg/mL), 10 mg CA-008 (0.1 mg/mL) and 15 mg CA-008 (0.15 mg/mL) | Drug | CA-008 10 mg (0.1 mg/mL) Cohort 2, CA-008 15 mg (0.15 mg/mL) Cohort 3, CA-008 5 mg (0.05 mg/mL) Cohort 1 |
| PlaceboPlacebo | Drug | Placebo - Cohort 1, Placebo - Cohorts 2 and 3 |
Primary outcome
Time-specific Mean Pain Intensity Scores (NRS) at Time 96 Hours for CA-008 vs. Placebo
Time frame: At 96 hours
Primary Efficacy Endpoint for the Pilot Stage. Time-specific mean pain intensity scores at Time 96 hours for CA-008 vs. placebo based on a 10-point numerical rating scale (NRS) from 0-10 where 0 is no pain and 10 is the worst pain imaginable).
CA-008 Dose vs. Placebo Comparison: Area Under the Curve (AUC) 0 to 96 Hours
Time frame: From 0 hours to 96 hours
Primary Efficacy Endpoint for Stage 2. Area Under the Curve (AUC) of the NRS current pain intensity scores from Time 0 hours to 96 hours at rest (AUC0 to 96h) where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. • During the inpatient stay, NRS at rest beginning with the PACU admission may be assessed once the subject is awake. The maximum is an NRS score of 10 x all 96 hours = 960 NRS units*hrs; the minimum is 0 x 96h = 0 NRS units*hrs
2 secondary outcomes
Percentage of Subjects Who do Not Require Opioids
Time frame: Time 0 hours to Time 96 hours: Opioid Free 0 hours to 96 hours
Total Opioid Consumption (in Daily Oral Morphine Equivalents)
Time frame: OC from Time 0 hours to Time 96 hours: OC 0 hours to 96 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daneshvari Solanki, MD principal investigator
First Surgical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CA-008 in people with Postsurgical Pain, run by Concentric Analgesics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-specific Mean Pain Intensity Scores (NRS) at Time 96 Hours for CA-008 vs. Placebo (time frame: At 96 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2022.