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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CA-008 (vocacapsaicin) | Active Comparator | Single administration |
|
| Placebo | Placebo Comparator | Single administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CA-008 (vocacapsaicin) | Drug | Single administration of CA-008 (vocacapsaicin) versus placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daneshvari Solanki, MD | First Surgical Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Surgical Hospital | Houston | Texas | 77004 | United States |
Sixty-seven patients were screened. Ten met requirements for open-label Part A and 24 were randomized to Part B. Patients meeting all inclusion and no exclusion criteria underwent VHR surgery and dosing on Day 1. The patient was closely followed during the outpatient portion to Day 29 post surgery. Part A began enrolling in September 2020 and Part B on 10FEB2021.
Part C was not conducted due to a corporate decision, and not due to any safety concerns.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | CA-008 (Vocacapsaicin), 15 mg - Part A | Single administration of CA-008 (vocacapsaicin), 15 mg (50 ml of a 0.3 mg/mL solution) Open-label, feasibility and safety assessment, exploration of different delivery techniques |
| FG001 | CA-008 (Vocacapsaicin), 24 mg - Part B | CA-008 (vocacapsaicin): single administration of CA-008 (vocacapsaicin), 24 mg (80 ml of a 0.3 mg/mL solution) Double-blind, randomized, placebo-controlled, parallel-group design. |
| FG002 | Placebo - Part B | Single administration of placebo Double-blind, randomized, placebo-controlled, parallel-group design. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CA-008 (Vocacapsaicin), 15 mg - Part A | Single administration of CA-008 (vocacapsaicin), 15 mg (50 ml of a 0.3 mg/mL solution) |
| BG001 | CA-008 (Vocacapsaicin), 24 mg - Part B | Single administration of CA-008 (vocacapsaicin), 24 mg (80 ml of a 0.3 mg/mL solution) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | modified Intent to Treat (mITT) population | Posted | Mean | Standard Deviation | score on a scale*hours | Up to 96 hours |
|
All AEs were recorded through at least 29 days, and on average 30.8 days, after the completion of surgery.
The definition of adverse events is consistent with clinicaltrials.gov definitions.
Additional optional information: verbatim terms used by Investigators to identify AEs were coded by system organ class (SOC) and PT using the Medical Dictionary for Regulatory Activities (MedDRA Version 24.0).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CA-008 (Vocacapsaicin), 15 mg - Part A | Single administration of CA-008 (vocacapsaicin), 15 mg (50 ml of a 0.3 mg/mL solution) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carrie Khouri, Associate Director of Clinical Operations | Concentric Analgesics | 1-415-484-7921 | ckhouri@concentricanalgesics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2021 | Jun 8, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 14, 2021 | Jun 8, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Placebo | Drug | Single administration of CA-008 (vocacapsaicin) versus placebo |
|
| 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). | Up to Day 8 |
| BG002 | Placebo - Part B | Single administration of placebo |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo - Part B | Single administration of placebo |
|
|
|
| Secondary | 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. | modified Intent to Treat (mITT) population | Posted | Mean | Standard Deviation | score on a scale*hours | Up to 96 hours |
|
|
|
|
| Secondary | 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). | modified Intent to Treat (mITT) population | Posted | Mean | Standard Deviation | mg morphine equivalents | Up to Day 8 |
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|
| 0 |
| 10 |
| 0 |
| 10 |
| 9 |
| 10 |
| EG001 | CA-008 (Vocacapsaicin), 24 mg - Part B | Single administration of CA-008 (vocacapsaicin), 24 mg (80 ml of a 0.3 mg/mL solution) | 0 | 12 | 0 | 12 | 10 | 12 |
| EG002 | Placebo - Part B | Single administration of placebo | 0 | 12 | 0 | 12 | 10 | 12 |
| Tachycardia | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Chest pain | General disorders | MedDRA (24.0) | Systematic Assessment |
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| Discomfort | General disorders | MedDRA (24.0) | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA (24.0) | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
|
| Incision site rash | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
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| Incision site vesicles | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
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| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA (24.0) | Systematic Assessment |
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| Blood Pressure Increased | Investigations | MedDRA (24.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (24.0) | Systematic Assessment |
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| Tachypenoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Blister | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (24.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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Disclosure restriction on the PI and/or institution:
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| After ambulation |
|
Applies to evoked measure for "after sitting up".
| ANOVA |
| 0.2158 |
| Mean Difference (Final Values) |
| -55.04 |
| Standard Error of the Mean |
| 43.190 |
| 2-Sided |
| 95 |
| -144.61 |
| 34.53 |
| Other |
ANOVA |
| Applies to evoked measure of "after ambulation". | ANOVA | 0.0777 | Mean Difference (Final Values) | -78.73 | Standard Error of the Mean | 42.532 | 2-Sided | 95 | -166.93 | 9.48 | Other | ANOVA |
| ANOVA |
| 0.5811 |
| Mean Difference (Final Values) |
| -8.125 |
| Standard Error of the Mean |
| 14.5059 |
| 2-Sided |
| 95 |
| -38.208 |
| 21.958 |
| Other |
ANOVA |