Study in Subjects Undergoing Complete Abdominoplasty
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|ClinicalTrials.gov Identifier: NCT03789318|
Recruitment Status : Completed
First Posted : December 28, 2018
Last Update Posted : July 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Postsurgical Pain||Drug: CA-008 Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Phase 2, Randomized, Double-blind, Placebo-Controlled Efficacy, Pharmacokinetics and Safety Study of CA-008 in Subjects Undergoing Complete Abdominoplasty|
|Actual Study Start Date :||December 3, 2018|
|Actual Primary Completion Date :||May 16, 2019|
|Actual Study Completion Date :||June 12, 2019|
|Active Comparator: CA-008||
Each cohort will use 5, 10, or 15mg CA-008 reconstituted in saline.
|Placebo Comparator: Placebo||
Each cohort will use placebo reconstituted in saline.
- Numerical Rating Scale for Pain (NRS) at a Specific Time [ Time Frame: At Time 96 hours ]Scale is 1-10. 1 is no pain. 10 is most intense pain. No subscales.
- Weighted Sum of Pain Intensity (SPI) Assessments = AUC of NRS scores [ Time Frame: From 0 to 96 hours ]
- Time to Opioid Cessation or Freedom [ Time Frame: One week ]
- Percent of Opioid Free Subjects [ Time Frame: Time 0 to 96 hours ]
- Total Opioid Consumption [ Time Frame: Time 0 to 96 hours ]
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): NCT03789318
|United States, California|
|Lotus Clinical Research, LLC|
|Pasadena, California, United States, 91105|
|Principal Investigator:||Alina Beaton, MD||Lotus Clinical Research, LLC|