Postsurgical PainPhase 1/2NCT04203537
Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)
A Phase 1/2 study testing CA-008 in people with Postsurgical Pain, run by Concentric Analgesics at 4 sites in United States.
Trial 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 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
- 193 participants
- Where
- 4 sitesUnited States
- Study dates
- 4 Dec 2019to 26 Oct 2020
- Phase
- Phase 1/2
- 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
- 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
Who cannot join
- Concurrent condition requiring analgesic treatment during study period
- Opioid tolerant
- Known allergy to capsaicin or other study medication
- Use of prohibited medications
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Legent Orthopedic Hospital
Carrollton, Texas, 75006
First Surgical Hospital
Houston, Texas, 77401
Lotus Clinical Reserach, LLC
Pasadena, California, 91105
Plano Surgical Hospital
Plano, Texas, 75093
About this study
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
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
- 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
Local administration during surgery
PlaceboDrug
Local administration during surgery
| Study group | Role | What they receive |
|---|---|---|
| CA-008 36 mg | Active comparator | Single administration (0.3 mg/mL concentration) Receives: Drug: CA-008 |
| CA-008 60 mg | Active comparator | Single administration (0.5 mg/mL concentration) Receives: Drug: CA-008 |
| CA-008 90 mg | Active comparator | Single administration (0.75 mg/mL concentration) Receives: Drug: CA-008 |
| Placebo | Placebo comparator | Single administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 to Day 15 post dose
Secondary outcomes (1)
Total Opioid Consumption
CA-008 versus placebo comparison, total opioid consumption in oral morphine equivalents
Measured: 0 to Day 15 post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start4 Dec 2019
- Primary completion26 Oct 2020
- Study completion26 Oct 2020
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part A: dose ascending, placebo-controlled Part B: randomized, double-blind, placebo-controlled, parallel design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concentric Analgesics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daneshvari Solanki, MD, Principal investigator, HD Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04203537
- Sponsor's protocol ID
- CA-PS-208
- Status last verified
- Apr 2024
- First submitted
- 16 Dec 2019
- Last updated
- 8 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04203537
- Acronym / sponsor ID
- CA-PS-208
- Conditions
- Postsurgical Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Concentric AnalgesicsIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2019 (actual)
- Primary completion
- 26 Oct 2020 (actual)
- Study completion
- 26 Oct 2020 (actual)
- First posted
- 18 Dec 2019 (actual)
- Results
- Posted 12 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Part A: dose ascending, placebo-controlled Part B: randomized, double-blind, placebo-controlled, parallel design
| Arm | Type | Receives |
|---|---|---|
| CA-008 36 mg | Active comparator | Drug: CA-008Single administration (0.3 mg/mL concentration) |
| CA-008 60 mg | Active comparator | Drug: CA-008Single administration (0.5 mg/mL concentration) |
| CA-008 90 mg | Active comparator | Drug: CA-008Single administration (0.75 mg/mL concentration) |
| Placebo | Placebo comparator | Drug: PlaceboSingle administration |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Concurrent condition requiring analgesic treatment during study period
- Opioid tolerant
- Known allergy to capsaicin or other study medication
- Use of prohibited medications
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: vocacapsaicinLocal administration during surgery | Drug | CA-008 36 mg, CA-008 60 mg, CA-008 90 mg |
| PlaceboLocal administration during surgery | Drug | Placebo |
Primary outcome
Pain Intensity Scores
Time frame: 0 to Day 15 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
1 secondary outcome
Total Opioid Consumption
Time frame: 0 to Day 15 post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- 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
HD Research
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CA-008 in people with Postsurgical Pain, run by Concentric Analgesics at 4 sites 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 4 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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 12 Jan 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?
Pain Intensity Scores (time frame: 0 to Day 15 post dose). 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 8 May 2024.