Open-Label CA-008 (Vocacapsaicin) in Bunionectomy

Pain Clinical Trial

Official title:

An Open-Label Study of Intraoperative CA-008 Administration in Subjects Undergoing Bunionectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03885596
• Other study ID #: CA-PS-205
• Status: Completed
• Phase: Phase 2
• Start date: March 25, 2019
• Est. completion date: October 22, 2019

Study information

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

Clinical Trial Summary

A Phase 2, open-label study of CA-008 to evaluate post-surgical pain control with CA-008.

Description:

This is a Phase 2, single-center, open-label study evaluating a single dose of CA-008 4.2 mg administered with different standard-of-care anesthetic regimens during an elective unilateral transpositional first metatarsal osteotomy for the correction of hallux valgus deformity (bunionectomy).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: October 22, 2019
• Est. primary completion date: July 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Healthy adult aged 18 - 65 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 = 36 kg/m2

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 study medications.

4. Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values

5. Have positive results on the alcohol test (breath or saliva) or urine drug screen.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• CA-008
Drug: CA-008 4.2 mg reconstituted in saline
• Ketorolac
30 mg IV at the onset of anesthesia
• Acetaminophen IV
1 g at the onset of anesthesia
• Fentanyl
100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery
• Bupivacaine Hydrochloride
0.25% 30 mL (75 mg) prior to surgery
• Lidocaine HCl
1.5% 12 mL at the end of surgery
• Celecoxib
200 mg PO bid each day postoperative
• Acetaminophen Oral
1 g postoperative
• Lidocaine Hydrochloride
2% 15 mL at the end of surgery
• Exparel
Bupivacaine liposome injection suspension

Locations

Country	Name	City	State
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	Area Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h	Area Under the Curve of pain intensity scores (using a Numeric Rating Scale of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable) over 72 hours	0-72 hours
Primary	Pain Intensity Scores at 24 Hours at Rest Using Numerical Rating Scale (NRS)	Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 24 hours	24 hours
Primary	Pain Intensity Scores at 48 Hours at Rest Using Numerical Rating Scale (NRS)	Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 48 hours	48 hours
Primary	Pain Intensity Scores at 72 Hours at Rest Using Numerical Rating Scale (NRS)	Numeric Rating Scale (NRS) of pain intensity from 0-10 where 0 is no pain and 10 is the worst pain imaginable at 72 hours	72 hours
Secondary	Opioid Consumption	Summary of opioid consumption in oral morphine equivalents	0-72 hours