A Phase 2 interventional study of CA-008 5 mg and Placebo in Postsurgical Pain, sponsored by Concentric Analgesics. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by Concentric Analgesics · Phase 2, Interventional, and Treatment
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.
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:
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 54 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →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.
Key Inclusion Criteria:
Key Exclusion Criteria:
The following are considered disallowed medications:
i. These drugs are permitted if prescribed for non-pain indications and the dose has been stable for at least 30 days prior to surgery.
ii. The use of benzodiazepines and the non-benzodiazepines are permitted to treat insomnia during the postoperative period.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Drug: CA-008 5 mg · Drug: Bupivacaine Hydrochloride · Drug: Hydromorphone · Drug: Fentanyl · Drug: Acetaminophen · Drug: Oxycodone
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).
Drug: Placebo · Drug: Bupivacaine Hydrochloride · Drug: Hydromorphone · Drug: Fentanyl · Drug: Acetaminophen · Drug: Oxycodone
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).
Drug: Bupivacaine Hydrochloride · Drug: Hydromorphone · Drug: Fentanyl · Drug: Acetaminophen · Drug: Oxycodone · Drug: CA-008 10 mg
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).
Drug: Bupivacaine Hydrochloride · Drug: Hydromorphone · Drug: Fentanyl · Drug: Acetaminophen · Drug: Oxycodone · Drug: CA-008 15 mg
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).
Drug: Placebo · Drug: Bupivacaine Hydrochloride · Drug: Hydromorphone · Drug: Fentanyl · Drug: Acetaminophen · Drug: Oxycodone
5 mg CA-008 reconstituted in saline.
Also known as: Vocacapsaicin
Each cohort will use placebo reconstituted in saline.
0.25% administered pre-surgery
0.02 mg/kg IV administered intraoperatively
100 mcg IV administered intraoperatively
1000 mg IV administered intraoperatively
5-10 mg PO administered post-surgery
10 mg CA-008 reconstituted in saline.
Also known as: Vocacapsaicin
15 mg CA-008 reconstituted in saline.
Also known as: Vocacapsaicin
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
Time frame: 96 hours
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
Time frame: 0 to 96 hours
Time to Opioid Cessation or Freedom
Time to the last use of opioid
Time frame: From Surgery to Day 29
Percent of Opioid Free Subjects
Percent of subjects who were opioid free at 24-96 hours
Time frame: 24 to 96 hours
Total Opioid Consumption
The sum of daily opioid consumption (in morphine equivalents)
Time frame: 0 to 96 hours
| Milestone | CA-008 5 mg (0.05 mg/mL) Cohort 1 | Placebo for Cohort 1 | CA-008 10 mg (0.1 mg/mL) Cohort 2 | CA-008 15 mg (0.15 mg/mL) Cohort 3 | Placebo for Cohorts 2 and 3 |
|---|---|---|---|---|---|
| Started | 9 | 9 | 12 | 12 | 12 |
| Completed | 9 | 9 | 9 | 11 | 12 |
| Not completed | 0 | 0 | 3 | 1 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 1 | 0 | 0 |
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
| score on a scale | CA-008 5 mg (0.05 mg/mL) Cohort 1 | Placebo for Cohort 1 | CA-008 10 mg (0.1 mg/mL) | CA-008 15 mg (0.15 mg/mL) | Placebo for Cohorts 2 and 3 |
|---|---|---|---|---|---|
| Pain Intensity Scores at 96 Hours at Rest Using Numerical Rating Scale (NRS) | 2.8 ± 2.59 | 2.0 ± 2.12 | 3.0 ± 2.22 | 2.8 ± 3.10 | 1.8 ± 1.96 |
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
| score on a scale*hours | CA-008 5 mg (0.05 mg/mL) Cohort 1 | Placebo for Cohort 1 | CA-008 10 mg (0.1 mg/mL) | CA-008 15 mg (0.15 mg/mL) | Placebo for Cohorts 2 and 3 |
|---|---|---|---|---|---|
| Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS Scores | 392.98 ± 138.191 | 392.67 ± 163.025 | 384.94 ± 136.551 | 406.88 ± 220.821 | 356.23 ± 175.969 |
Time to the last use of opioid
| hours | CA-008 5 mg (0.05 mg/mL) Cohort 1 | Placebo for Cohort 1 | CA-008 10 mg (0.1 mg/mL) | CA-008 15 mg (0.15 mg/mL) | Placebo for Cohorts 2 and 3 |
|---|---|---|---|---|---|
| Time to Opioid Cessation or Freedom | 56.37 (1.25 to 216.65) | 55.42 (1.08 to 156.20) | 83.89 (0.95 to 323.22) | 59.55 (1.13 to 362.63) | 42.26 (1.02 to 238.57) |
Percent of subjects who were opioid free at 24-96 hours
| Participants | CA-008 5 mg (0.05 mg/mL) Cohort 1 | Placebo for Cohort 1 | CA-008 10 mg (0.1 mg/mL) | CA-008 15 mg (0.15 mg/mL) | Placebo for Cohorts 2 and 3 |
|---|---|---|---|---|---|
| Percent of Opioid Free Subjects | 0 | 0 | 1 | 1 | 0 |
The sum of daily opioid consumption (in morphine equivalents)
| mg morphine equivalents | CA-008 5 mg (0.05 mg/mL) Cohort 1 | Placebo for Cohort 1 | CA-008 10 mg (0.1 mg/mL) | CA-008 15 mg (0.15 mg/mL) | Placebo for Cohorts 2 and 3 |
|---|---|---|---|---|---|
| Total Opioid Consumption | 85.83 ± 52.246 | 96.67 ± 63.134 | 69.77 ± 41.710 | 58.00 ± 69.170 | 77.85 ± 72.524 |
Collected over Approximately 76 days per subject from screening to the day 29 (D29) visit (however this could be longer to follow any AE to resolution or establishment of a new baseline). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CA-008 5 mg (0.05 mg/mL) Cohort 1 | 0/9 (0%) | 2/9 (22.2%) | 9/9 (100%) |
| Placebo for Cohort 1 | 0/9 (0%) | 0/9 (0%) | 8/9 (88.9%) |
| CA-008 10 mg (0.1 mg/mL) | 0/12 (0%) | 1/12 (8.3%) | 11/12 (91.7%) |
| CA-008 15 mg (0.15 mg/mL) | 0/12 (0%) | 1/12 (8.3%) | 10/12 (83.3%) |
| Placebo for Cohorts 2 and 3 | 0/12 (0%) | 0/12 (0%) | 11/12 (91.7%) |
| Event | CA-008 5 mg (0.05 mg/mL) Cohort 1 | Placebo for Cohort 1 | CA-008 10 mg (0.1 mg/mL) | CA-008 15 mg (0.15 mg/mL) | Placebo for Cohorts 2 and 3 |
|---|---|---|---|---|---|
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/9 | 0/9 | 0/12 | 0/12 | 0/12 |
| Deep vein thrombosisVascular disorders | 1/9 | 0/9 | 0/12 | 0/12 | 0/12 |
| Post procedural haemorrhageInjury, poisoning and procedural complications | 0/9 | 0/9 | 1/12 | 1/12 | 0/12 |
| Event | CA-008 5 mg (0.05 mg/mL) Cohort 1 | Placebo for Cohort 1 | CA-008 10 mg (0.1 mg/mL) | CA-008 15 mg (0.15 mg/mL) | Placebo for Cohorts 2 and 3 |
|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 5/9 | 8/9 | 6/12 | 5/12 | 3/12 |
| Back painMusculoskeletal and connective tissue disorders | 3/9 | 4/9 | 3/12 | 4/12 | 5/12 |
| HeadacheNervous system disorders | 4/9 | 1/9 | 1/12 | 2/12 | 2/12 |
| ConstipationGastrointestinal disorders | 3/9 | 2/9 | 1/12 | 2/12 | 4/12 |
| VomitingGastrointestinal disorders | 0/9 | 2/9 | 0/12 | 2/12 | 0/12 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/9 | 0/9 | 0/12 | 2/12 | 0/12 |
| Incision site cellulitisInfections and infestations | 1/9 | 0/9 | 0/12 | 0/12 | 1/12 |
| SeromaInjury, poisoning and procedural complications | 1/9 | 0/9 | 0/12 | 0/12 | 0/12 |
| Wound dehiscenceInjury, poisoning and procedural complications | 0/9 | 1/9 | 0/12 | 0/12 | 0/12 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/9 | 0/9 | 0/12 | 0/12 | 0/12 |
| Age, Continuous(years) | CA-008 5 mg (0.05 mg/mL) Cohort 1 | Placebo for Cohort 1 | CA-008 10 mg (0.1 mg/mL) | CA-008 15 mg (0.15 mg/mL) | Placebo for Cohorts 2 and 3 | Total |
|---|---|---|---|---|---|---|
| Mean | 37.8 ± 10.95 | 38.2 ± 7.17 | 43.3 ± 10.27 | 43.3 ± 6.74 | 38.3 ± 8.76 | 40.4 ± 8.93 |
| Sex: Female, Male(Participants) | CA-008 5 mg (0.05 mg/mL) Cohort 1 | Placebo for Cohort 1 | CA-008 10 mg (0.1 mg/mL) | CA-008 15 mg (0.15 mg/mL) | Placebo for Cohorts 2 and 3 | Total |
|---|---|---|---|---|---|---|
| Female | 9 | 9 | 12 | 12 | 12 | 54 |
| Male | 0 | 0 | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | CA-008 5 mg (0.05 mg/mL) Cohort 1 | Placebo for Cohort 1 | CA-008 10 mg (0.1 mg/mL) | CA-008 15 mg (0.15 mg/mL) | Placebo for Cohorts 2 and 3 | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 5 | 6 | 4 | 6 | 4 | 25 |
| Not Hispanic or Latino | 4 | 3 | 8 | 6 | 8 | 29 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | CA-008 5 mg (0.05 mg/mL) Cohort 1 | Placebo for Cohort 1 | CA-008 10 mg (0.1 mg/mL) | CA-008 15 mg (0.15 mg/mL) | Placebo for Cohorts 2 and 3 | Total |
|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 | 1 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 1 | 1 |
| Black or African American | 1 | 1 | 6 | 3 | 6 | 17 |
| White | 7 | 8 | 5 | 8 | 5 | 33 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | CA-008 5 mg (0.05 mg/mL) Cohort 1 | Placebo for Cohort 1 | CA-008 10 mg (0.1 mg/mL) | CA-008 15 mg (0.15 mg/mL) | Placebo for Cohorts 2 and 3 | Total |
|---|---|---|---|---|---|---|
| United States | 9 | 9 | 12 | 12 | 12 | 54 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Concentric Analgesics