Post-surgical PainPhase 2NCT03599089
Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients
A Phase 2 study testing CA-008, Ketorolac and Acetaminophen in people with Post-surgical Pain, run by Concentric Analgesics at 3 sites in United States.
Trial summary
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating a single dose of one of three CA-008 dose levels vs. placebo injected during an elective bunionectomy Bunionectomy to assess post-surgical pain management and the need for rescue medication (oxycodone). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-surgical Pain
- What is being tested?
- CA-008, Ketorolac and Acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Jul 2018to 23 Oct 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy adult aged 18 - 75 years old
- American Society of Anesthesiology (ASA) physical Class 1, 2 or 3
- Planning elective Bunionectomy repair
- For both males and females: using an acceptable method of birth control
- If a female: not pregnant or breastfeeding
- Have a body mass index ≤ 40 kg/m2.
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- Be willing and able to sign the informed consent form (ICF)
- Be able to complete study procedures and pain scales and to communicate meaningfully in English
- Be willing to undergo 17 blood draws for pharmacokinetic (PK )assessments over 24 hours
Who cannot join
- Have another painful condition, other than bunion-related pain, that may require pain treatment during the study period
- Have active skin disease or another 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, bupivacaine HCl, ketorolac, acetaminophen or oxycodone.
- Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
- Be on any medication not allowed per the protocol
- Within the past year have a history of illicit drug use or prescription medicine or alcohol abuse
Show all 9Show fewer
- Have positive results on the alcohol test (breath or saliva) or urine drug screen
- Have previously participated in a clinical study with CA-008.
- Have participated in another clinical trial or used an investigational product within 30 days or five half-lives (whichever is longer)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
HD Research Corp
Houston, Texas, 77004
Lotus Clinical Research, LLC
Pasadena, California, 91105
Chesapeake Research Group
Pasadena, Maryland, 21122
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Safety, Pharmacokinetics and Efficacy Study of CA-008 in Subjects Undergoing Bunionectomy
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating a single dose of one of three CA-008 dose levels vs. placebo injected during an elective bunionectomy Bunionectomy to assess post-surgical pain management and the need for rescue medication (oxycodone).
Read the detailed description
Primary Objective:
To evaluate the efficacy of a single intraoperative administration of CA- 008 vs placebo in subjects undergoing an elective Bunionectomy .
Secondary Objectives
- To evaluate the safety and tolerability of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy.
- To evaluate the PK profile of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy .
- To explore the efficacy of various doses of CA-008 administered intraoperatively in subjects undergoing an elective Bunionectomy .
- Conditions
- Post-surgical Pain
- Being tested
- CA-008, Placebo, Ketorolac, Acetaminophen, Oxycodone
- 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
single-dose wound infiltration prior to surgical incision closure
PlaceboDrug
single-dose wound infiltration prior to surgical incision closure
KetorolacDrug
30mg IV administered intraoperatively
AcetaminophenDrug
1000mg IV administered intraoperatively
OxycodoneDrug
5mg PO prn post-surgery
Bupivacaine HydrochlorideDrug
0.5% infiltration pre-surgery
| Study group | Role | What they receive |
|---|---|---|
| CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration) | Active comparator | Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. Receives: Drug: CA-008; Drug: Ketorolac; Drug: Acetaminophen; Drug: Oxycodone; Drug: Bupivacaine Hydrochloride |
| CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration) | Active comparator | Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. Receives: Drug: CA-008; Drug: Ketorolac; Drug: Acetaminophen; Drug: Oxycodone; Drug: Bupivacaine Hydrochloride |
| CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration) | Active comparator | Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. Receives: Drug: CA-008; Drug: Ketorolac; Drug: Acetaminophen; Drug: Oxycodone; Drug: Bupivacaine Hydrochloride |
| Placebo | Placebo comparator | Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. Receives: Drug: Placebo; Drug: Ketorolac; Drug: Acetaminophen; Drug: Oxycodone; Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Postsurgical Pain Based on the Weighted Sum of Pain Intensity (SPI) Assessments Over 96 Hours of the NRS Scores = Area Under the Curve (AUC)
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. The time was collected 0 to 96 hours post-dose
Measured: [time frame: 96 hours]
Secondary outcomes (2)
Percentage of Subjects Opioid Free
Percentage of subjects who are opioid-free for CA-008 compared to placebo.
Measured: [time frame: 96 hours]
Total Opioid Consumption (in Daily Morphine Equivalents)
Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo
Measured: [time frame: 96 hours]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start9 Jul 2018
- Primary completion10 Oct 2018
- Study completion23 Oct 2018
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 Post-surgical 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
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concentric Analgesics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy Wu, Study director, Concentric Analgesics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599089
- Sponsor's protocol ID
- CA-PS-201
- Status last verified
- Jul 2021
- First submitted
- 27 Jun 2018
- Last updated
- 11 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled Safety, Pharmacokinetics and Efficacy Study of CA-008 in Subjects Undergoing Bunionectomy
- ClinicalTrials.gov ID
- NCT03599089
- Acronym / sponsor ID
- CA-PS-201
- Conditions
- Post-surgical Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Concentric AnalgesicsIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 10 Oct 2018 (actual)
- Study completion
- 23 Oct 2018 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 11 Aug 2021
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 Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating a single dose of one of three CA-008 dose levels vs. placebo injected during an elective bunionectomy Bunionectomy to assess post-surgical pain management and the need for rescue medication (oxycodone).
Detailed description
Primary Objective:
To evaluate the efficacy of a single intraoperative administration of CA- 008 vs placebo in subjects undergoing an elective Bunionectomy .
Secondary Objectives
- To evaluate the safety and tolerability of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy.
- To evaluate the PK profile of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy .
- To explore the efficacy of various doses of CA-008 administered intraoperatively in subjects undergoing an elective Bunionectomy .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration) | Active comparator | Drug: CA-008, Drug: Ketorolac, Drug: Acetaminophen, Drug: Oxycodone, Drug: Bupivacaine HydrochlorideEach patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. |
| CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration) | Active comparator | Drug: CA-008, Drug: Ketorolac, Drug: Acetaminophen, Drug: Oxycodone, Drug: Bupivacaine HydrochlorideEach patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. |
| CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration) | Active comparator | Drug: CA-008, Drug: Ketorolac, Drug: Acetaminophen, Drug: Oxycodone, Drug: Bupivacaine HydrochlorideEach patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Ketorolac, Drug: Acetaminophen, Drug: Oxycodone, Drug: Bupivacaine HydrochlorideEach patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy adult aged 18 - 75 years old
- American Society of Anesthesiology (ASA) physical Class 1, 2 or 3
- Planning elective Bunionectomy repair
- For both males and females: using an acceptable method of birth control
- If a female: not pregnant or breastfeeding
Key exclusion criteria (9 listed)
- Have another painful condition, other than bunion-related pain, that may require pain treatment during the study period
- Have active skin disease or another 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, bupivacaine HCl, ketorolac, acetaminophen or oxycodone.
- Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
- Be on any medication not allowed per the protocol
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: Vocacapsaicinsingle-dose wound infiltration prior to surgical incision closure | Drug | CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration), CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration), CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration) |
| Placebosingle-dose wound infiltration prior to surgical incision closure | Drug | Placebo |
| Ketorolac30mg IV administered intraoperatively | Drug | CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration), CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration), CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration), Placebo |
| Acetaminophen1000mg IV administered intraoperatively | Drug | CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration), CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration), CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration), Placebo |
| Oxycodone5mg PO prn post-surgery | Drug | CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration), CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration), CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration), Placebo |
| Bupivacaine Hydrochloride0.5% infiltration pre-surgery | Drug | CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration), CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration), CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration), Placebo |
Primary outcome
Change in Postsurgical Pain Based on the Weighted Sum of Pain Intensity (SPI) Assessments Over 96 Hours of the NRS Scores = Area Under the Curve (AUC)
Time frame: [time frame: 96 hours]
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. The time was collected 0 to 96 hours post-dose
2 secondary outcomes
Percentage of Subjects Opioid Free
Time frame: [time frame: 96 hours]
Total Opioid Consumption (in Daily Morphine Equivalents)
Time frame: [time frame: 96 hours]
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nancy Wu study director
Concentric Analgesics
3 sites 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, Ketorolac and Acetaminophen in people with Post-surgical Pain, run by Concentric Analgesics at 3 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 9 inclusion and 9 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 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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 11 Aug 2021). 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?
Change in Postsurgical Pain Based on the Weighted Sum of Pain Intensity (SPI) Assessments Over 96 Hours of the NRS Scores = Area Under the Curve (AUC) (time frame: [time frame: 96 hours]). 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 11 Aug 2021.