Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

Post-surgical Pain Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Placebo-controlled Safety, Pharmacokinetics and Efficacy Study of CA-008 in Subjects Undergoing Bunionectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599089
• Other study ID #: CA-PS-201
• Status: Completed
• Phase: Phase 2
• Start date: July 9, 2018
• Est. completion date: October 23, 2018

Study information

• Verified date: July 2021
• Source: Concentric Analgesics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: October 23, 2018
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-surgical Pain

Intervention

Drug:
• CA-008
single-dose wound infiltration prior to surgical incision closure
• Placebo
single-dose wound infiltration prior to surgical incision closure
• Ketorolac
30mg IV administered intraoperatively
• Acetaminophen
1000mg IV administered intraoperatively
• Oxycodone
5mg PO prn post-surgery
• Bupivacaine Hydrochloride
0.5% infiltration pre-surgery

Locations

Country	Name	City	State
United States	HD Research Corp	Houston	Texas
United States	Chesapeake Research Group	Pasadena	Maryland
United States	Lotus Clinical Research, LLC	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Concentric Analgesics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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. The time was collected 0 to 96 hours post-dose	[time frame: 96 hours]
Secondary	Percentage of Subjects Opioid Free	Percentage of subjects who are opioid-free for CA-008 compared to placebo.	[time frame: 96 hours]
Secondary	Total Opioid Consumption (in Daily Morphine Equivalents)	Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo	[time frame: 96 hours]