Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In the pilot (Part A) of this study, multiple doses of CA-008 (vocacapsaicin) were evaluated for safety, tolerability, and PK. Doses were then selected for the expanded part (Part B) of the study, where CA-008 was compared to placebo. Patients had serial assessments of safety, PK, and drug effect.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CA-008 36 mg | Active Comparator | Single administration (0.3 mg/mL concentration) |
|
| CA-008 60 mg | Active Comparator | Single administration (0.5 mg/mL concentration) |
|
| CA-008 90 mg | Active Comparator | Single administration (0.75 mg/mL concentration) |
|
| Placebo | Placebo Comparator | Single administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CA-008 | Drug | Local administration during surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Scores | 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. AUC is calculated using the standard trapezoidal rule from serial measures of NRS taken every 4 hours from 0-96 hours following surgery and twice daily from 96h to Day 15 | 0 to Day 15 post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption | CA-008 versus placebo comparison, total opioid consumption in oral morphine equivalents | 0 to Day 15 post dose |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daneshvari Solanki, MD | HD Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Clinical Reserach, LLC | Pasadena | California | 91105 | United States | ||
| Legent Orthopedic Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Of the 193 enrolled participants, 193 met inclusion criteria and were randomized to treatment. 1 patient randomized to the 36 mg cohort and 1 patient randomized to the 60 mg cohort received placebo. These two patients were included in the placebo group. The efficacy and safety data from Parts A and B of the study are pooled by treatment group for the placebo, 30 mg and 60 mg treatment groups.
Part A consisted of 3 small, sequential, placebo-controlled, dose-escalation cohorts evaluating 36, 60 and 90 mg for safety. Part B evaluated 36 and 60 mg compared to placebo in parallel, randomized groups. Efficacy data from Part A remained blinded until the end of Part B and these data were pooled for analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | CA-008 36 mg (Patients From Part A) | Single administration CA-008 (vocacapsaicin): Local administration during surgery |
| FG001 | CA-008 60 mg (Patients From Part A) | Single administration CA-008 (vocacapsaicin): Local administration during surgery |
| FG002 | CA-008 90 mg (Patients From Part A) | Single administration CA-008 (vocacapsaicin): Local administration during surgery |
| FG003 | Placebo (Patients From Part A) | Single administration Placebo: Local administration during surgery |
| FG004 | CA-008 36 mg (Patients From Part B) | Single administration CA-008 (vocacapsaicin): Local administration during surgery |
| FG005 | CA-008 60 mg (Patients From Part B) | Single administration CA-008 (vocacapsaicin): Local administration during surgery |
| FG006 | Placebo (Patients From Part B) | Single administration Placebo: Local administration during surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
1 subject was randomized to CA-008 60 mg, but actually received placebo
1 subject was randomized to CA-008 36 mg, but actually received placebo
Both subjects are included in the placebo arm
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | CA-008 36 mg | Single administration CA-008: Local administration during surgery |
| BG001 | CA-008 60 mg | Single administration CA-008: Local administration during surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Intensity Scores | 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. AUC is calculated using the standard trapezoidal rule from serial measures of NRS taken every 4 hours from 0-96 hours following surgery and twice daily from 96h to Day 15 | 193 patients - Modified Intent-to-Treat One patient who was randomized to CA-008 36 mg, but actually received Placebo is included in CA-008 36 mg. One patient who was randomized to CA-008 60 mg, but actually received Placebo is included in CA-008 60 mg. | Posted | Mean | Standard Deviation | scores on a scale*hours | 0 to Day 15 post dose |
|
Adverse event data were collected up to 76 days for participants in the study. This was comprised of a screening period that could be up to 45 days and subsequent clinic visits through Day 29.
The definition of adverse event and/or serious adverse event, used to collect adverse event information in this study did not differ from the clinicaltrials.gov definitions.
Not provided
| 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 36 mg | Single administration CA-008: Local administration during surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nancy Wu | Concentric Analgesics | (415) 484-7921 | nancy@concentricanalgesics.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 22, 2020 | Jun 23, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 12, 2020 | Jun 23, 2021 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
Part A: dose ascending, placebo-controlled Part B: randomized, double-blind, placebo-controlled, parallel design
Not provided
Not provided
Not provided
| Placebo | Drug | Local administration during surgery |
|
| Carrollton |
| Texas |
| 75006 |
| United States |
| First Surgical Hospital | Houston | Texas | 77401 | United States |
| Plano Surgical Hospital | Plano | Texas | 75093 | United States |
| BG002 | CA-008 90 mg | Single administration CA-008: Local administration during surgery |
| BG003 | Placebo | Single administration Placebo: Local administration during surgery |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | CA-008 60 mg (0.5 mg/mL Concentration) | Single administration CA-008: Local administration during surgery |
| OG002 | CA-008 90 mg (0.75 mg/mL Concentration) | Single administration CA-008: Local administration during surgery |
| OG003 | Placebo | Single administration Placebo: Local administration during surgery |
|
|
|
| Secondary | Total Opioid Consumption | CA-008 versus placebo comparison, total opioid consumption in oral morphine equivalents | 193 patients - Modified Intent-to-Treat One patient who was randomized to CA-008 36 mg, but actually received Placebo is included in CA-008 36 mg. One patient who was randomized to CA-008 60 mg, but actually received Placebo is included in CA-008 60 mg. Opioid consumption (OC) in oral morphine equivalent dose (OME) | Posted | Mean | Standard Deviation | mg morphine equivalents | 0 to Day 15 post dose |
|
|
|
|
| 0 |
| 60 |
| 2 |
| 60 |
| 54 |
| 60 |
| EG001 | CA-008 60 mg | Single administration CA-008: Local administration during surgery | 0 | 61 | 1 | 61 | 58 | 61 |
| EG002 | CA-008 90 mg | Single administration CA-008: Local administration during surgery | 0 | 6 | 0 | 6 | 6 | 6 |
| EG003 | Placebo | Single administration Placebo: Local administration during surgery | 0 | 66 | 2 | 66 | 66 | 66 |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Drug ineffective | General disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Lip swelling | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Infusion site pruritus | General disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Drug hypersensitivity | Immune system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Injection site infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Incision site discharge | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Incision site haemorrhage | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Incision site vesicles | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Post procedural fever | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Post procedural oedema | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Wound secretion | Injury, poisoning and procedural complications | MedDRA 22.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 22.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 22.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 22.1 | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 22.1 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 22.1 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 22.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 22.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 22.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Gout | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Scrotal swelling | Reproductive system and breast disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Bradypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Skin induration | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Diastolic hypotension | Vascular disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.1 | Non-systematic Assessment |
|
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| OC0-96 hours |
|
| OC 0- Day 15 |
|
| Superiority |