Clinical trial NCT03599089: Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled Safety, Pharmacokinetics and Efficacy Study of CA-008 in Subjects Undergoing Bunionectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-surgical Pain
Lead sponsor: Concentric Analgesics
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: Primary Objective:

To evaluate the efficacy of a single intraoperative administration of CA- 008 vs placebo in subjects undergoing an elective Bunionectomy .

Secondary Objectives

* To evaluate the safety and tolerability of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy.
* To evaluate the PK profile of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy .
* To explore the efficacy of various doses of CA-008 administered intraoperatively in subjects undergoing an elective Bunionectomy .

Eligibility criteria: Inclusion Criteria:

1. Healthy adult aged 18 - 75 years old
2. American Society of Anesthesiology (ASA) physical Class 1, 2 or 3
3. Planning elective Bunionectomy repair
4. For both males and females: using an acceptable method of birth control
5. If a female: not pregnant or breastfeeding
6. Have a body mass index ≤ 40 kg/m2.
7. Be willing and able to sign the informed consent form (ICF)
8. Be able to complete study procedures and pain scales and to communicate meaningfully in English
9. Be willing to undergo 17 blood draws for pharmacokinetic (PK )assessments over 24 hours

Exclusion Criteria:

1. Have another painful condition, other than bunion-related pain, that may require pain treatment during the study period
2. Have active skin disease or another abnormality at the anticipated site of surgery that could interfere with the planned surgery.
3. Have a known allergy to chili peppers, capsaicin or the components of CA-008, bupivacaine HCl, ketorolac, acetaminophen or oxycodone.
4. Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
5. Be on any medication not allowed per the protocol
6. Within the past year have a history of illicit drug use or prescription medicine or alcohol abuse
7. Have positive results on the alcohol test (breath or saliva) or urine drug screen
8. Have previously participated in a clinical study with CA-008.
9. Have participated in another clinical trial or used an investigational product within 30 days or five half-lives (whichever is longer)

Primary outcomes:
measure: 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)
timeFrame: [time frame: 96 hours]
Secondary outcomes:
measure: Percentage of Subjects Opioid Free
timeFrame: [time frame: 96 hours]
measure: Total Opioid Consumption (in Daily Morphine Equivalents)
timeFrame: [time frame: 96 hours]
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Lotus Clinical Research, LLC
state: California
city: Pasadena
country: United States
facility: Chesapeake Research Group
state: Maryland
city: Houston
country: United States
facility: HD Research Corp
state: Texas
Study officials:
affiliation: Concentric Analgesics
name: Nancy Wu
role: STUDY_DIRECTOR
References: