Clinical trial NCT03731364: Study of CA-008 (Vocacapsaicin) in Total Knee Arthroplasty
Official title: A Phase 2, Randomized, Double-blind, Placebo-Controlled Efficacy, Pharmacokinetics and Safety Study of CA-008 (Vocacapsaicin) in Subjects Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postsurgical Pain
Lead sponsor: Concentric Analgesics
Sponsor class: INDUSTRY
First posted: 2018-11-06
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a two-part, Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 (vocacapsaicin) vs. placebo injected/instilled during an elective TKA.

Detailed description: This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating, in a pilot stage of the study, up to 3 ascending dose level cohorts each evaluating a single dose of CA-008 vs. placebo injected/instilled during an elective TKA. Up to 54 subjects will be randomized in the pilot stage. During the optional second stage of the study, subjects will be randomized to one of either 2 or 3 CA-008 dose levels (to be determined) or placebo. The Sponsor made the decision not to proceed with the second stage.

Eligibility criteria: Key Inclusion Criteria:

1. Plan to undergo an elective primary unilateral total knee arthroplasty (TKA or knee replacement), without collateral procedure or additional surgeries.
2. Be a reasonably healthy adult aged 18 - 80 years old, inclusive, with a BMI ≤ 36 kg/m2 and American Society of Anesthesiology (ASA) physical Class 1, 2 or 3 at the time of randomization.
3. Males and females must abstain from intercourse, use acceptable birth control methods or be sterile or otherwise incapable of having children.
4. Be willing and able to sign the informed consent form (ICF)
5. Be willing and able to complete study procedures and pain scales and to communicate meaningfully in English. Be able and willing to return for outpatient follow up visits as required.

Key Exclusion Criteria:

1. In the opinion of the Investigator,

   1. have a concurrent painful condition, other than pain in the knee to be replaced, that may require pain treatment during the study period.
   2. have active skin disease or other clinically significant abnormality at the anticipated site of surgery that could interfere with the planned surgery.
2. Have a known allergy to chili peppers, capsaicin or the components of CA-008, ropivacaine, ketorolac, acetaminophen, fentanyl, hydromorphone, morphine or oxycodone.
3. Have significant medical, neuropsychiatric or other condition.
4. The following are considered disallowed medications:

   1. tolerant to opioids as defined
   2. capsaicin-containing products or foods.
   3. central nervous system active agent as an analgesic adjunct medication
   4. antiarrhythmics except beta-blockers, digoxin, warfarin, lithium, or aminoglycosides or other antibiotics for an infection
   5. parenteral or oral corticosteroids.
   6. antianginal, antihypertensive agent or diabetic regimen at a dose that has not been stable for at least 30 days or which is not expected to remain stable while participating in the study.
5. Have positive results on the alcohol breath/saliva test indicative of alcohol abuse or urine drug screen indicative of illicit drug use at screening, and/or prior to surgery.

Primary outcomes:
measure: Time-specific Mean Pain Intensity Scores (NRS) at Time 96 Hours for CA-008 vs. Placebo
timeFrame: At 96 hours
measure: CA-008 Dose vs. Placebo Comparison: Area Under the Curve (AUC) 0 to 96 Hours
timeFrame: From 0 hours to 96 hours
Secondary outcomes:
measure: Percentage of Subjects Who do Not Require Opioids
timeFrame: Time 0 hours to Time 96 hours: Opioid Free 0 hours to 96 hours
measure: Total Opioid Consumption (in Daily Oral Morphine Equivalents)
timeFrame: OC from Time 0 hours to Time 96 hours: OC 0 hours to 96 hours
Other outcomes:
Locations:
city: Houston
country: United States
facility: HD Research
state: Texas
Study officials:
affiliation: First Surgical Hospital
name: Daneshvari Solanki, MD
role: PRINCIPAL_INVESTIGATOR
References: