Postsurgical PainPhase 2NCT03789318
Study in Subjects Undergoing Complete Abdominoplasty
A Phase 2 study testing CA-008 5 mg, Bupivacaine Hydrochloride and Hydromorphone in people with Postsurgical Pain, run by Concentric Analgesics at 1 site in United States.
Trial summary
Phase 2, single center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 vs. placebo in subjects undergoing an elective C-ABD under general anesthesia supplemented with a bupivacaine hydrochloride (HCl)transverse abdominis plane (TAP) block. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postsurgical Pain
- What is being tested?
- CA-008 5 mg, Bupivacaine Hydrochloride and Hydromorphone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2018to 12 Jun 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Plan to undergo an elective complete abdominoplasty (C-ABD), without collateral procedure or additional surgeries.
- In the medical judgment of the investigator, be a reasonably healthy adult aged 18 - 65 years old, inclusive, and American Society of Anesthesiology (ASA) physical Class 1 or 2 at the time of randomization.
- Unless the subject has a same sex partner, he or she must either be sterile (surgically or biologically) or commit to an acceptable method of birth control while participating in the study.
- Have a body mass index ≤ 35 kg/m².
- Be willing and able to sign the informed consent form (ICF) approved by an Institutional Review Board (IRB).
Who cannot join
- In the opinion of the Investigator, have a concurrent painful condition that may require analgesic treatment during the study period or may confound post-surgical pain assessments.
- Have a known allergy to chili peppers, capsaicin or the components of CA-008, acetaminophen, bupivacaine, fentanyl hydromorphone or oxycodone.
- As determined by the investigator have a history or clinical manifestation of significant medical, neuropsychiatric or other condition, including a clinically significant existing arrhythmia, left bundle branch block or abnormal ECG, myocardial infarction or coronary arterial bypass graft surgery within the prior 12 months, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation or interfere with study assessments.
- The following are considered disallowed medications:
- Be tolerant to opioids defined as those who have been receiving or have received chronic opioid therapy greater than 15 mg of oral morphine equivalents per day for greater than 3 out of 7 days per week over a one-month period within 6 months of screening.
- Within 1 day prior to surgery and throughout the inpatient period, be taking any capsaicin-containing products, such as dietary supplements or over-the-counter (OTC) preparations, including topical formulations, and prescription medications.
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- Within the 7 days prior to surgery, be taking any central nervous system (CNS) active agent as an analgesic adjunct medication, such as anticonvulsants, antidepressants, benzodiazepines, sedative- hypnotics, clonidine and other central alpha-2 agents, ketamine or muscle relaxants.
- These drugs are permitted if prescribed for non-pain indications and the dose has been stable for at least 30 days prior to surgery.
- The use of benzodiazepines and the non-benzodiazepines are permitted to treat insomnia during the postoperative period.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lotus Clinical Research, LLC
Pasadena, California, 91105
About this study
Official title: A Phase 2, Randomized, Double-blind, Placebo-Controlled Efficacy, Pharmacokinetics and Safety Study of CA-008 in Subjects Undergoing Complete Abdominoplasty
Phase 2, single center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 vs. placebo in subjects undergoing an elective C-ABD under general anesthesia supplemented with a bupivacaine hydrochloride (HCl)transverse abdominis plane (TAP) block.
Read the detailed description
This is a Phase 2, single-center, randomized, double-blind, placebo-controlled, parallel design study evaluating up to 4 ascending dose level cohorts, each evaluating a single dose of CA-008 vs. placebo injected/instilled during an elective C-ABD. Up to 72 subjects may be randomized in 4 cohorts.
For each subject, postsurgical assessments will be conducted in two parts:
- Inpatient period: starts with completion of study treatment injection (T0) and continues through 96 hours (T96h).
- Outpatient period: begins on discharge from the inpatient unit through various follow up visits to day 29 (D29)/week 4 (W4) after surgery. Note that additional follow up visits may occur at any time or even after D29/W4 to follow adverse events (AEs) to resolution or establishment of a new baseline.
- Conditions
- Postsurgical Pain
- Being tested
- CA-008 5 mg, Placebo, Bupivacaine Hydrochloride, Hydromorphone, Fentanyl
- 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-008 5 mgDrug
Also called Vocacapsaicin
5 mg CA-008 reconstituted in saline.
PlaceboDrug
Each cohort will use placebo reconstituted in saline.
Bupivacaine HydrochlorideDrug
0.25% administered pre-surgery
HydromorphoneDrug
0.02 mg/kg IV administered intraoperatively
FentanylDrug
100 mcg IV administered intraoperatively
AcetaminophenDrug
1000 mg IV administered intraoperatively
OxycodoneDrug
5-10 mg PO administered post-surgery
CA-008 10 mgDrug
Also called Vocacapsaicin
10 mg CA-008 reconstituted in saline.
CA-008 15 mgDrug
Also called Vocacapsaicin
15 mg CA-008 reconstituted in saline.
| Study group | Role | What they receive |
|---|---|---|
| CA-008 5 mg (0.05 mg/mL) Cohort 1 | Active comparator | Cohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Receives: Drug: CA-008 5 mg; Drug: Bupivacaine Hydrochloride; Drug: Hydromorphone; Drug: Fentanyl; Drug: Acetaminophen; Drug: Oxycodone |
| Placebo for Cohort 1 | Placebo comparator | Cohort 1:
Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Receives: Drug: Placebo; Drug: Bupivacaine Hydrochloride; Drug: Hydromorphone; Drug: Fentanyl; Drug: Acetaminophen; Drug: Oxycodone |
| CA-008 10 mg (0.1 mg/mL) | Active comparator | Cohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Receives: Drug: Bupivacaine Hydrochloride; Drug: Hydromorphone; Drug: Fentanyl; Drug: Acetaminophen; Drug: Oxycodone; Drug: CA-008 10 mg |
| CA-008 15 mg (0.15 mg/mL) | Active comparator | Cohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Receives: Drug: Bupivacaine Hydrochloride; Drug: Hydromorphone; Drug: Fentanyl; Drug: Acetaminophen; Drug: Oxycodone; Drug: CA-008 15 mg |
| Placebo for Cohorts 2 and 3 | Placebo comparator | Cohorts 2 \& 3:
Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator.
The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). Receives: Drug: Placebo; Drug: Bupivacaine Hydrochloride; Drug: Hydromorphone; Drug: Fentanyl; Drug: Acetaminophen; Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity Scores at 96 Hours at Rest Using Numerical Rating Scale (NRS)
Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 96 hours
Measured: 96 hours
Secondary outcomes (4)
Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS Scores
Pain intensity scores (using a Numeric Rating Scale of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable) from 0 to T96 hours
Measured: 0 to 96 hours
Time to Opioid Cessation or Freedom
Time to the last use of opioid
Measured: From Surgery to Day 29
Percent of Opioid Free Subjects
Percent of subjects who were opioid free at 24-96 hours
Measured: 24 to 96 hours
Total Opioid Consumption
The sum of daily opioid consumption (in morphine equivalents)
Measured: 0 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 posted28 Dec 2018
- Study start3 Dec 2018
- Primary completion16 May 2019
- Study completion12 Jun 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concentric Analgesics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alina Beaton, MD, Principal investigator, Lotus Clinical Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789318
- Sponsor's protocol ID
- CA-PS-204
- Status last verified
- Mar 2024
- First submitted
- 2 Dec 2018
- Last updated
- 19 Mar 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 19 Mar 2024. 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 in Subjects Undergoing Complete Abdominoplasty
- ClinicalTrials.gov ID
- NCT03789318
- Acronym / sponsor ID
- CA-PS-204
- Conditions
- Postsurgical Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Concentric AnalgesicsIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 16 May 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 28 Dec 2018 (actual)
- Results
- Posted 13 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2, single center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 vs. placebo in subjects undergoing an elective C-ABD under general anesthesia supplemented with a bupivacaine hydrochloride (HCl)transverse abdominis plane (TAP) block.
Detailed description
This is a Phase 2, single-center, randomized, double-blind, placebo-controlled, parallel design study evaluating up to 4 ascending dose level cohorts, each evaluating a single dose of CA-008 vs. placebo injected/instilled during an elective C-ABD. Up to 72 subjects may be randomized in 4 cohorts.
For each subject, postsurgical assessments will be conducted in two parts:
- Inpatient period: starts with completion of study treatment injection (T0) and continues through 96 hours (T96h).
- Outpatient period: begins on discharge from the inpatient unit through various follow up visits to day 29 (D29)/week 4 (W4) after surgery. Note that additional follow up visits may occur at any time or even after D29/W4 to follow adverse events (AEs) to resolution or establishment of a new baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| CA-008 5 mg (0.05 mg/mL) Cohort 1 | Active comparator | Drug: CA-008 5 mg, Drug: Bupivacaine Hydrochloride, Drug: Hydromorphone, Drug: Fentanyl, Drug: Acetaminophen, Drug: OxycodoneCohort 1 (CA-008 5 mg): the surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). |
| Placebo for Cohort 1 | Placebo comparator | Drug: Placebo, Drug: Bupivacaine Hydrochloride, Drug: Hydromorphone, Drug: Fentanyl, Drug: Acetaminophen, Drug: OxycodoneCohort 1: Placebo comparator is identical in appearance to the investigational product, containing the same excipients as the active comparator. The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). |
| CA-008 10 mg (0.1 mg/mL) | Active comparator | Drug: Bupivacaine Hydrochloride, Drug: Hydromorphone, Drug: Fentanyl, Drug: Acetaminophen, Drug: Oxycodone, Drug: CA-008 10 mgCohort 2 (CA-008 10 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). |
| CA-008 15 mg (0.15 mg/mL) | Active comparator | Drug: Bupivacaine Hydrochloride, Drug: Hydromorphone, Drug: Fentanyl, Drug: Acetaminophen, Drug: Oxycodone, Drug: CA-008 15 mgCohort 3 (CA-008 15 mg): the surgery is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). |
| Placebo for Cohorts 2 and 3 | Placebo comparator | Drug: Placebo, Drug: Bupivacaine Hydrochloride, Drug: Hydromorphone, Drug: Fentanyl, Drug: Acetaminophen, Drug: OxycodoneCohorts 2 \& 3: Placebo comparator in each cohort is identical in appearance to the investigational product, containing the same excipients as the active comparator. The surgery for each subject is to be performed under general anesthesia supplemented by a transverse abdominis plane (TAP) block and local surgical site infiltration. Prior to the surgery, perform the TAP block as a single injection of 0.25% bupivacaine hydrochloride (HCl) 60 mL (150 mg). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Plan to undergo an elective complete abdominoplasty (C-ABD), without collateral procedure or additional surgeries.
- In the medical judgment of the investigator, be a reasonably healthy adult aged 18 - 65 years old, inclusive, and American Society of Anesthesiology (ASA) physical Class 1 or 2 at the time of randomization.
- Unless the subject has a same sex partner, he or she must either be sterile (surgically or biologically) or commit to an acceptable method of birth control while participating in the study.
- Have a body mass index ≤ 35 kg/m².
- Be willing and able to sign the informed consent form (ICF) approved by an Institutional Review Board (IRB).
Key exclusion criteria (9 listed)
- In the opinion of the Investigator, have a concurrent painful condition that may require analgesic treatment during the study period or may confound post-surgical pain assessments.
- Have a known allergy to chili peppers, capsaicin or the components of CA-008, acetaminophen, bupivacaine, fentanyl hydromorphone or oxycodone.
- As determined by the investigator have a history or clinical manifestation of significant medical, neuropsychiatric or other condition, including a clinically significant existing arrhythmia, left bundle branch block or abnormal ECG, myocardial infarction or coronary arterial bypass graft surgery within the prior 12 months, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation or interfere with study assessments.
- The following are considered disallowed medications:
- The use of benzodiazepines and the non-benzodiazepines are permitted to treat insomnia during the postoperative period.
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-008 5 mgAlso: Vocacapsaicin5 mg CA-008 reconstituted in saline. | Drug | CA-008 5 mg (0.05 mg/mL) Cohort 1 |
| PlaceboEach cohort will use placebo reconstituted in saline. | Drug | Placebo for Cohort 1, Placebo for Cohorts 2 and 3 |
| Bupivacaine Hydrochloride0.25% administered pre-surgery | Drug | CA-008 10 mg (0.1 mg/mL), CA-008 15 mg (0.15 mg/mL), CA-008 5 mg (0.05 mg/mL) Cohort 1, Placebo for Cohort 1, Placebo for Cohorts 2 and 3 |
| Hydromorphone0.02 mg/kg IV administered intraoperatively | Drug | CA-008 10 mg (0.1 mg/mL), CA-008 15 mg (0.15 mg/mL), CA-008 5 mg (0.05 mg/mL) Cohort 1, Placebo for Cohort 1, Placebo for Cohorts 2 and 3 |
| Fentanyl100 mcg IV administered intraoperatively | Drug | CA-008 10 mg (0.1 mg/mL), CA-008 15 mg (0.15 mg/mL), CA-008 5 mg (0.05 mg/mL) Cohort 1, Placebo for Cohort 1, Placebo for Cohorts 2 and 3 |
| Acetaminophen1000 mg IV administered intraoperatively | Drug | CA-008 10 mg (0.1 mg/mL), CA-008 15 mg (0.15 mg/mL), CA-008 5 mg (0.05 mg/mL) Cohort 1, Placebo for Cohort 1, Placebo for Cohorts 2 and 3 |
| Oxycodone5-10 mg PO administered post-surgery | Drug | CA-008 10 mg (0.1 mg/mL), CA-008 15 mg (0.15 mg/mL), CA-008 5 mg (0.05 mg/mL) Cohort 1, Placebo for Cohort 1, Placebo for Cohorts 2 and 3 |
| CA-008 10 mgAlso: Vocacapsaicin10 mg CA-008 reconstituted in saline. | Drug | CA-008 10 mg (0.1 mg/mL) |
| CA-008 15 mgAlso: Vocacapsaicin15 mg CA-008 reconstituted in saline. | Drug | CA-008 15 mg (0.15 mg/mL) |
Primary outcome
Pain Intensity Scores at 96 Hours at Rest Using Numerical Rating Scale (NRS)
Time frame: 96 hours
Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 96 hours
4 secondary outcomes
Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS Scores
Time frame: 0 to 96 hours
Time to Opioid Cessation or Freedom
Time frame: From Surgery to Day 29
Percent of Opioid Free Subjects
Time frame: 24 to 96 hours
Total Opioid Consumption
Time frame: 0 to 96 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 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.
Alina Beaton, MD principal investigator
Lotus Clinical Research, LLC
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 5 mg, Bupivacaine Hydrochloride and Hydromorphone 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 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 19 Mar 2024. 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 13 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 at 96 Hours at Rest Using Numerical Rating Scale (NRS) (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 19 Mar 2024.