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Open-Label CA-008 (Vocacapsaicin) in Bunionectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885596
Recruitment Status : Completed
First Posted : March 21, 2019
Results First Posted : October 27, 2021
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
Concentric Analgesics

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

Condition or disease Intervention/treatment Phase
Pain Drug: CA-008 Drug: Ketorolac Drug: Acetaminophen IV Drug: Fentanyl Drug: Bupivacaine Hydrochloride Drug: Lidocaine HCl Drug: Celecoxib Drug: Acetaminophen Oral Drug: Lidocaine Hydrochloride Drug: Exparel Phase 2

Detailed 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study of Intraoperative CA-008 Administration in Subjects Undergoing Bunionectomy
Actual Study Start Date : March 25, 2019
Actual Primary Completion Date : July 2, 2019
Actual Study Completion Date : October 22, 2019

Arm Intervention/treatment
Experimental: CA-008 Cohort 1

CA-008 4.2 mg reconstituted in saline

All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.

Drug: CA-008
Drug: CA-008 4.2 mg reconstituted in saline
Other Name: Vocacapsaicin

Drug: Ketorolac
30 mg IV at the onset of anesthesia

Drug: Acetaminophen IV
1 g at the onset of anesthesia

Drug: Fentanyl
100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery

Drug: Bupivacaine Hydrochloride
0.25% 30 mL (75 mg) prior to surgery

Drug: Lidocaine HCl
1.5% 12 mL at the end of surgery

Drug: Celecoxib
200 mg PO bid each day postoperative

Drug: Acetaminophen Oral
1 g postoperative

Experimental: CA-008 Cohort 2

CA-008 4.2 mg reconstituted in saline

All subjects received monitored anesthesia care (MAC) and a Mayo block.

Drug: CA-008
Drug: CA-008 4.2 mg reconstituted in saline
Other Name: Vocacapsaicin

Drug: Ketorolac
30 mg IV at the onset of anesthesia

Drug: Acetaminophen IV
1 g at the onset of anesthesia

Drug: Fentanyl
100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery

Drug: Bupivacaine Hydrochloride
0.25% 30 mL (75 mg) prior to surgery

Drug: Celecoxib
200 mg PO bid each day postoperative

Drug: Acetaminophen Oral
1 g postoperative

Drug: Lidocaine Hydrochloride
2% 15 mL at the end of surgery

Experimental: CA-008 Cohort 3

CA-008 4.2 mg reconstituted in saline

All subjects received monitored anesthesia care (MAC) and a Mayo block.

Drug: CA-008
Drug: CA-008 4.2 mg reconstituted in saline
Other Name: Vocacapsaicin

Drug: Ketorolac
30 mg IV at the onset of anesthesia

Drug: Acetaminophen IV
1 g at the onset of anesthesia

Drug: Fentanyl
100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery

Drug: Bupivacaine Hydrochloride
0.25% 30 mL (75 mg) prior to surgery

Drug: Lidocaine Hydrochloride
2% 15 mL at the end of surgery

Active Comparator: Exparel

106 mg [8 mL of the 133 mg/10 mL suspension] only

All subjects received monitored anesthesia care (MAC) and a Mayo block.

Drug: Ketorolac
30 mg IV at the onset of anesthesia

Drug: Acetaminophen IV
1 g at the onset of anesthesia

Drug: Fentanyl
100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery

Drug: Bupivacaine Hydrochloride
0.25% 30 mL (75 mg) prior to surgery

Drug: Lidocaine Hydrochloride
2% 15 mL at the end of surgery

Drug: Exparel
Bupivacaine liposome injection suspension




Primary Outcome Measures :
  1. Area Under the Curve (AUC) of Numerical Rating Scale (NRS) Scores (at Rest) Over 72h [ Time Frame: 0-72 hours ]
    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

  2. Pain Intensity Scores at 24 Hours at Rest Using Numerical Rating Scale (NRS) [ Time Frame: 24 hours ]
    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

  3. Pain Intensity Scores at 48 Hours at Rest Using Numerical Rating Scale (NRS) [ Time Frame: 48 hours ]
    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

  4. Pain Intensity Scores at 72 Hours at Rest Using Numerical Rating Scale (NRS) [ Time Frame: 72 hours ]
    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


Secondary Outcome Measures :
  1. Opioid Consumption [ Time Frame: 0-72 hours ]
    Summary of opioid consumption in oral morphine equivalents



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885596


Locations
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United States, California
Lotus Clinical Research, LLC
Pasadena, California, United States, 91105
Sponsors and Collaborators
Concentric Analgesics
Investigators
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Study Director: Nancy Wu Concentric Analgesics
  Study Documents (Full-Text)

Documents provided by Concentric Analgesics:
Study Protocol  [PDF] May 2, 2019
Statistical Analysis Plan  [PDF] June 5, 2019

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Responsible Party: Concentric Analgesics
ClinicalTrials.gov Identifier: NCT03885596    
Other Study ID Numbers: CA-PS-205
First Posted: March 21, 2019    Key Record Dates
Results First Posted: October 27, 2021
Last Update Posted: October 27, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Acetaminophen
Celecoxib
Ketorolac
Lidocaine
Fentanyl
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors