A Phase 1/2 interventional study of CA-008 (vocacapsaicin) and Placebo in Postsurgical Pain, sponsored by Concentric Analgesics. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-09-14.
Sponsored by Concentric Analgesics · Phase 1/2, Interventional, and Treatment
A Three-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics, and Preliminary Efficacy Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's enrollment of 34 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.
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.
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.
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.
Single administration
Drug: CA-008 (vocacapsaicin)
Single administration
Drug: Placebo
Single administration of CA-008 (vocacapsaicin) versus placebo
Single administration of CA-008 (vocacapsaicin) versus placebo
Pain at Rest - Part B
Pain at rest measured by a Numeric Rating Scale (NRS) from time 0 to 96 hours (AUC 0-96). NRS pain scores at rest were collected at 1, 2, 4, 6, 8, 12, 16, 20, 24 and every 4 hours there after post the time of entry into the PACU (while the patient is awake), until discharge from the inpatient until at 96 hour. NRS area under the curve (AUC) is the weighted sum of current pain intensity assessments for a specified time interval. The NRS ranks pain from 0-10; zero being no pain present and 10 being the worst possible pain. Other than 0 and 10, no other pain ratings (2-9) were labeled.
Time frame: Up to 96 hours
Evoked NRS - Part B
Evoked NRS pain scores (three maneuvers: coughing, sitting up, walking) from time 0-96 hours. Evoked NRS scores were obtained twice daily in the morning at 10:00AM (± 1h) and in the afternoon at 4:00PM (±1 h). NRS area under the curve (AUC) is the weighted sum of current pain intensity assessments for a specified time interval. The NRS ranks pain from 0-10; zero being no pain present and 10 being the worst possible pain. Other than 0 and 10, no other pain ratings (2-9) were labeled.
Time frame: Up to 96 hours
Opioid Consumption - Part B
Total opioid consumption (OC) converted to an oral morphine equivalent (OME) dose from 0 to 96 hours (OC 0-T96) and 0 to Day 8 (OC 0-D8).
Time frame: Up to Day 8
The clinical trial was conducted at one clinical research surgical center from September 2020 until June 2021. Qualified patients are adults aged 18 to 80 years of age, inclusive, who are planning to undergo an elective, open laparotomy for ventral hernia repair (VHR), with retromuscular, preperitoneal mesh repair and who otherwise meet eligibility criteria.
| Milestone | CA-008 (Vocacapsaicin), 15 mg - Part A | CA-008 (Vocacapsaicin), 24 mg - Part B | Placebo - Part B |
|---|---|---|---|
| Started | 10 | 12 | 12 |
| Follow-up to 29 days post surgery | 10 | 12 | 12 |
| Completed | 10 | 12 | 12 |
| Not completed | 0 | 0 | 0 |
Pain at rest measured by a Numeric Rating Scale (NRS) from time 0 to 96 hours (AUC 0-96). NRS pain scores at rest were collected at 1, 2, 4, 6, 8, 12, 16, 20, 24 and every 4 hours there after post the time of entry into the PACU (while the patient is awake), until discharge from the inpatient until at 96 hour. NRS area under the curve (AUC) is the weighted sum of current pain intensity assessments for a specified time interval. The NRS ranks pain from 0-10; zero being no pain present and 10 being the worst possible pain. Other than 0 and 10, no other pain ratings (2-9) were labeled.
| score on a scale*hours | CA-008 (Vocacapsaicin), 24 mg - Part B | Placebo - Part B |
|---|---|---|
| Pain at Rest - Part B | 148.98 ± 146.68 | 188.26 ± 120.60 |
Evoked NRS pain scores (three maneuvers: coughing, sitting up, walking) from time 0-96 hours. Evoked NRS scores were obtained twice daily in the morning at 10:00AM (± 1h) and in the afternoon at 4:00PM (±1 h). NRS area under the curve (AUC) is the weighted sum of current pain intensity assessments for a specified time interval. The NRS ranks pain from 0-10; zero being no pain present and 10 being the worst possible pain. Other than 0 and 10, no other pain ratings (2-9) were labeled.
| score on a scale*hours | CA-008 (Vocacapsaicin), 24 mg - Part B | Placebo - Part B |
|---|---|---|
| Coughing | 187.58 ± 176.49 | 345.66 ± 135.50 |
| Sitting-up | 116.24 ± 105.90 | 171.28 ± 105.69 |
| After ambulation | 143.42 ± 112.71 | 222.14 ± 94.89 |
Total opioid consumption (OC) converted to an oral morphine equivalent (OME) dose from 0 to 96 hours (OC 0-T96) and 0 to Day 8 (OC 0-D8).
| mg morphine equivalents | CA-008 (Vocacapsaicin), 24 mg | Placebo |
|---|---|---|
| OC 0 to 96 hours | 27.18 ± 31.63 | 36.56 ± 30.70 |
| OC 0 to Day 8 | 29.68 ± 37.66 | 37.81 ± 33.27 |
Collected over All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CA-008 (Vocacapsaicin), 15 mg - Part A | 0/10 (0%) | 0/10 (0%) | 9/10 (90%) |
| CA-008 (Vocacapsaicin), 24 mg - Part B | 0/12 (0%) | 0/12 (0%) | 10/12 (83.3%) |
| Placebo - Part B | 0/12 (0%) | 0/12 (0%) | 10/12 (83.3%) |
| Event | CA-008 (Vocacapsaicin), 15 mg - Part A | CA-008 (Vocacapsaicin), 24 mg - Part B | Placebo - Part B |
|---|---|---|---|
| ConstipationGastrointestinal disorders | 6/10 | 6/12 | 8/12 |
| NauseaGastrointestinal disorders | 2/10 | 4/12 | 1/12 |
| TachycardiaCardiac disorders | 0/10 | 3/12 | 2/12 |
| HeadacheNervous system disorders | 2/10 | 0/12 | 0/12 |
| VomitingGastrointestinal disorders | 0/10 | 2/12 | 0/12 |
| Postoperative wound infectionInfections and infestations | 0/10 | 0/12 | 2/12 |
| Incision site vesiclesInjury, poisoning and procedural complications | 0/10 | 0/12 | 2/12 |
| DizzinessNervous system disorders | 1/10 | 2/12 | 1/12 |
| BradycardiaCardiac disorders | 1/10 | 1/12 | 0/12 |
| Abdominal discomfortGastrointestinal disorders | 1/10 | 1/12 | 1/12 |
| Age, Categorical(Participants) | CA-008 (Vocacapsaicin), 15 mg - Part A | CA-008 (Vocacapsaicin), 24 mg - Part B | Placebo - Part B | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 10 | 12 | 12 | 34 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | CA-008 (Vocacapsaicin), 15 mg - Part A | CA-008 (Vocacapsaicin), 24 mg - Part B | Placebo - Part B | Total |
|---|---|---|---|---|
| Mean | 47.9 ± 10.8 | 47.1 ± 10.16 | 42.2 ± 10.19 | 45.6 ± 10.4 |
| Sex: Female, Male(Participants) | CA-008 (Vocacapsaicin), 15 mg - Part A | CA-008 (Vocacapsaicin), 24 mg - Part B | Placebo - Part B | Total |
|---|---|---|---|---|
| Female | 2 | 4 | 3 | 9 |
| Male | 8 | 8 | 9 | 25 |
| Ethnicity (NIH/OMB)(Participants) | CA-008 (Vocacapsaicin), 15 mg - Part A | CA-008 (Vocacapsaicin), 24 mg - Part B | Placebo - Part B | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 8 | 6 | 15 |
| Not Hispanic or Latino | 9 | 4 | 6 | 19 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | CA-008 (Vocacapsaicin), 15 mg - Part A | CA-008 (Vocacapsaicin), 24 mg - Part B | Placebo - Part B | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 | 2 |
| White | 9 | 12 | 11 | 32 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | CA-008 (Vocacapsaicin), 15 mg - Part A | CA-008 (Vocacapsaicin), 24 mg - Part B | Placebo - Part B | Total |
|---|---|---|---|---|
| United States | 10 | 12 | 12 | 34 |
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Studies of the drug tested here: Vocacapsaicin
Concentric Analgesics