A Phase 2 interventional study of CA-008 and Placebo in Post-surgical Pain, sponsored by Concentric Analgesics. Completed at 3 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-08-11.
Sponsored by Concentric Analgesics · Phase 2, Interventional, and Treatment
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).
Primary Objective:
To evaluate the efficacy of a single intraoperative administration of CA- 008 vs placebo in subjects undergoing an elective Bunionectomy .
Secondary Objectives
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 147 is above 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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: CA-008 · Drug: Ketorolac · Drug: Acetaminophen · Drug: Oxycodone · Drug: Bupivacaine Hydrochloride
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.
Drug: CA-008 · Drug: Ketorolac · Drug: Acetaminophen · Drug: Oxycodone · Drug: Bupivacaine Hydrochloride
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.
Drug: CA-008 · Drug: Ketorolac · Drug: Acetaminophen · Drug: Oxycodone · Drug: Bupivacaine Hydrochloride
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.
Drug: Placebo · Drug: Ketorolac · Drug: Acetaminophen · Drug: Oxycodone · Drug: Bupivacaine Hydrochloride
single-dose wound infiltration prior to surgical incision closure
Also known as: Vocacapsaicin
single-dose wound infiltration prior to surgical incision closure
30mg IV administered intraoperatively
1000mg IV administered intraoperatively
5mg PO prn post-surgery
0.5% infiltration pre-surgery
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
Time frame: [time frame: 96 hours]
Percentage of Subjects Opioid Free
Percentage of subjects who are opioid-free for CA-008 compared to placebo.
Time frame: [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
Time frame: [time frame: 96 hours]
| Milestone | CA-008 0.7 mg (0.05 mg/mL Concentration) | CA-008 2.1 mg (0.15 mg/mL Concentration) | CA-008 4.2 mg (0.3 mg/mL Concentration) | Placebo |
|---|---|---|---|---|
| Started | 36 | 36 | 38 | 37 |
| Completed | 33 | 35 | 37 | 35 |
| Not completed | 3 | 1 | 1 | 2 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 1 | 0 | 0 |
| Withdrew: Lack of efficacy | 0 | 0 | 1 | 2 |
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
| scores on a scale*hour | CA-008 0.7 mg (0.05 mg/mL Concentration) | CA-008 2.1 mg (0.15 mg/mL Concentration) | CA-008 4.2 mg (0.3 mg/mL Concentration) | Placebo |
|---|---|---|---|---|
| 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) | 317.09 ± 204.291 | 321.72 ± 165.145 | 266.86 ± 220.674 | 400.56 ± 215.471 |
Percentage of subjects who are opioid-free for CA-008 compared to placebo.
| percentage of subjects | CA-008 0.7 mg (0.05 mg/mL Concentration) | CA-008 2.1 mg (0.15 mg/mL Concentration) | CA-008 4.2 mg (0.3 mg/mL Concentration) | Placebo |
|---|---|---|---|---|
| Percentage of Subjects Opioid Free | 19.4 | 16.7 | 26.3 | 5.4 |
Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo
| mg morphine equivalents/day | CA-008 0.7 mg (0.05 mg/mL Concentration) | CA-008 2.1 mg (0.15 mg/mL Concentration) | CA-008 4.2 mg (0.3 mg/mL Concentration) | Placebo |
|---|---|---|---|---|
| Total Opioid Consumption (in Daily Morphine Equivalents) | 42.50 ± 38.074 | 37.71 ± 39.340 | 28.22 ± 28.355 | 56.11 ± 45.447 |
Collected over Adverse event data was collected from the time that each participant provided written informed consent (up to 45-day screening period) through Day 36+2 days. The total duration could be a maximum of 83 days.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CA-008 0.7 mg (0.05 mg/mL Concentration) | 0/36 (0%) | 0/36 (0%) | 27/36 (75%) |
| CA-008 2.1 mg (0.15 mg/mL Concentration) | 0/36 (0%) | 0/36 (0%) | 28/36 (77.8%) |
| CA-008 4.2 mg (0.3 mg/mL Concentration) | 0/38 (0%) | 0/38 (0%) | 26/38 (68.4%) |
| Placebo | 0/37 (0%) | 1/37 (2.7%) | 25/37 (67.6%) |
| Event | CA-008 0.7 mg (0.05 mg/mL Concentration) | CA-008 2.1 mg (0.15 mg/mL Concentration) | CA-008 4.2 mg (0.3 mg/mL Concentration) | Placebo |
|---|---|---|---|---|
| Cellulitis on left big toeInfections and infestations | 0/36 | 0/36 | 0/38 | 1/37 |
| Event | CA-008 0.7 mg (0.05 mg/mL Concentration) | CA-008 2.1 mg (0.15 mg/mL Concentration) | CA-008 4.2 mg (0.3 mg/mL Concentration) | Placebo |
|---|---|---|---|---|
| NauseaGastrointestinal disorders | 6/36 | 7/36 | 7/38 | 9/37 |
| HeadacheNervous system disorders | 7/36 | 8/36 | 7/38 | 6/37 |
| Wound dehiscenceInjury, poisoning and procedural complications | 2/36 | 5/36 | 3/38 | 5/37 |
| DizzinessNervous system disorders | 4/36 | 5/36 | 1/38 | 2/37 |
| VomitingGastrointestinal disorders | 1/36 | 4/36 | 3/38 | 4/37 |
| PolyuriaRenal and urinary disorders | 0/36 | 4/36 | 0/38 | 0/37 |
| ConstipationGastrointestinal disorders | 3/36 | 2/36 | 1/38 | 4/37 |
| Infusion site oedemaGeneral disorders | 3/36 | 0/36 | 1/38 | 2/37 |
| Muscle spasmsMusculoskeletal and connective tissue disorders | 0/36 | 3/36 | 0/38 | 0/37 |
| Alanine aminotransferase increasedInvestigations | 0/36 | 0/36 | 3/38 | 0/37 |
| Age, Continuous(years) | CA-008 0.7 mg (0.05 mg/mL Concentration) | CA-008 2.1 mg (0.15 mg/mL Concentration) | CA-008 4.2 mg (0.3 mg/mL Concentration) | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 48.9 ± 12.29 | 44.6 ± 12.33 | 41.4 ± 12.16 | 50.7 ± 12.46 | 46.4 ± 12.73 |
| Sex: Female, Male(Participants) | CA-008 0.7 mg (0.05 mg/mL Concentration) | CA-008 2.1 mg (0.15 mg/mL Concentration) | CA-008 4.2 mg (0.3 mg/mL Concentration) | Placebo | Total |
|---|---|---|---|---|---|
| Female | 33 | 25 | 34 | 31 | 123 |
| Male | 3 | 11 | 4 | 6 | 24 |
| Ethnicity (NIH/OMB)(Participants) | CA-008 0.7 mg (0.05 mg/mL Concentration) | CA-008 2.1 mg (0.15 mg/mL Concentration) | CA-008 4.2 mg (0.3 mg/mL Concentration) | Placebo | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 8 | 11 | 8 | 12 | 39 |
| Not Hispanic or Latino | 28 | 25 | 30 | 25 | 108 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | CA-008 0.7 mg (0.05 mg/mL Concentration) | CA-008 2.1 mg (0.15 mg/mL Concentration) | CA-008 4.2 mg (0.3 mg/mL Concentration) | Placebo | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 | 0 | 2 |
| Asian | 0 | 0 | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 0 | 1 | 2 |
| Black or African American | 12 | 12 | 14 | 14 | 52 |
| White | 20 | 20 | 19 | 22 | 81 |
| More than one race | 3 | 3 | 2 | 0 | 8 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Region of Enrollment(Participants) | CA-008 0.7 mg (0.05 mg/mL Concentration) | CA-008 2.1 mg (0.15 mg/mL Concentration) | CA-008 4.2 mg (0.3 mg/mL Concentration) | Placebo | Total |
|---|---|---|---|---|---|
| United States | 36 | 36 | 38 | 37 | 147 |
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Studies of the drug tested here: Vocacapsaicin
Concentric Analgesics