Study in Subjects Undergoing Complete Abdominoplasty

Postsurgical Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03789318
• Other study ID #: CA-PS-204
• Status: Completed
• Phase: Phase 2
• Start date: December 3, 2018
• Est. completion date: June 12, 2019

Study information

• Verified date: March 2024
• Source: Concentric Analgesics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 2, single center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 vs. placebo in subjects undergoing an elective C-ABD under general anesthesia supplemented with a bupivacaine hydrochloride (HCl)transverse abdominis plane (TAP) block.

Description:

This is a Phase 2, single-center, randomized, double-blind, placebo-controlled, parallel design study evaluating up to 4 ascending dose level cohorts, each evaluating a single dose of CA-008 vs. placebo injected/instilled during an elective C-ABD. Up to 72 subjects may be randomized in 4 cohorts.

For each subject, postsurgical assessments will be conducted in two parts:

• Inpatient period: starts with completion of study treatment injection (T0) and continues through 96 hours (T96h).

• Outpatient period: begins on discharge from the inpatient unit through various follow up visits to day 29 (D29)/week 4 (W4) after surgery. Note that additional follow up visits may occur at any time or even after D29/W4 to follow adverse events (AEs) to resolution or establishment of a new baseline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 12, 2019
• Est. primary completion date: May 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Key Inclusion Criteria:

• Plan to undergo an elective complete abdominoplasty (C-ABD), without collateral procedure or additional surgeries.

• In the medical judgment of the investigator, be a reasonably healthy adult aged 18 - 65 years old, inclusive, and American Society of Anesthesiology (ASA) physical Class 1 or 2 at the time of randomization.

• Unless the subject has a same sex partner, he or she must either be sterile (surgically or biologically) or commit to an acceptable method of birth control while participating in the study.

• Have a body mass index = 35 kg/m².

• Be willing and able to sign the informed consent form (ICF) approved by an Institutional Review Board (IRB).

Key Exclusion Criteria:

• In the opinion of the Investigator, have a concurrent painful condition that may require analgesic treatment during the study period or may confound post-surgical pain assessments.

• Have a known allergy to chili peppers, capsaicin or the components of CA-008, acetaminophen, bupivacaine, fentanyl hydromorphone or oxycodone.

• As determined by the investigator have a history or clinical manifestation of significant medical, neuropsychiatric or other condition, including a clinically significant existing arrhythmia, left bundle branch block or abnormal ECG, myocardial infarction or coronary arterial bypass graft surgery within the prior 12 months, significant abnormal clinical laboratory test value, or known bleeding abnormality that could preclude or impair study participation or interfere with study assessments.

• The following are considered disallowed medications:

1. Be tolerant to opioids defined as those who have been receiving or have received chronic opioid therapy greater than 15 mg of oral morphine equivalents per day for greater than 3 out of 7 days per week over a one-month period within 6 months of screening.

2. Within 1 day prior to surgery and throughout the inpatient period, be taking any capsaicin-containing products, such as dietary supplements or over-the-counter (OTC) preparations, including topical formulations, and prescription medications.

3. Within the 7 days prior to surgery, be taking any central nervous system (CNS) active agent as an analgesic adjunct medication, such as anticonvulsants, antidepressants, benzodiazepines, sedative- hypnotics, clonidine and other central alpha-2 agents, ketamine or muscle relaxants.

i. These drugs are permitted if prescribed for non-pain indications and the dose has been stable for at least 30 days prior to surgery.

ii. The use of benzodiazepines and the non-benzodiazepines are permitted to treat insomnia during the postoperative period.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postsurgical Pain

Intervention

Drug:
• CA-008 5 mg
5 mg CA-008 reconstituted in saline.
• Placebo
Each cohort will use placebo reconstituted in saline.
• Bupivacaine Hydrochloride
0.25% administered pre-surgery
• Hydromorphone
0.02 mg/kg IV administered intraoperatively
• Fentanyl
100 mcg IV administered intraoperatively
• Acetaminophen
1000 mg IV administered intraoperatively
• Oxycodone
5-10 mg PO administered post-surgery
• CA-008 10 mg
10 mg CA-008 reconstituted in saline.
• CA-008 15 mg
15 mg CA-008 reconstituted in saline.

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	Pain Intensity Scores at 96 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 96 hours	96 hours
Secondary	Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS Scores	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) from 0 to T96 hours	0 to 96 hours
Secondary	Time to Opioid Cessation or Freedom	Time to the last use of opioid	From Surgery to Day 29
Secondary	Percent of Opioid Free Subjects	Percent of subjects who were opioid free at 24-96 hours	24 to 96 hours
Secondary	Total Opioid Consumption	The sum of daily opioid consumption (in morphine equivalents)	0 to 96 hours