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
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04774328 -
Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair
|
Phase 1/Phase 2 | |
Completed |
NCT03731364 -
Study of CA-008 (Vocacapsaicin) in Total Knee Arthroplasty
|
Phase 2 | |
Recruiting |
NCT05193227 -
Sustained Release Lidocaine for the Treatment of Postoperative Pain
|
Phase 2 | |
Completed |
NCT01562483 -
The Analgesic Efficacy of Δ9-THC (Namisol®) in Patients With Persistent Postsurgical Abdominal Pain
|
Phase 2 | |
Completed |
NCT02081703 -
Study to Evaluate Safety/Efficacy of a Single Pre-Op Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery
|
Phase 2 | |
Recruiting |
NCT04647435 -
Efficacy and Safety of APSCTC for the Treatment of Postsurgical Pain Due to Third Molar Extraction
|
Phase 3 | |
Completed |
NCT01582477 -
TAP-patients With Robotic Assisted Lap Prostatectomy
|
Phase 4 | |
Suspended |
NCT04681027 -
Safety, Tolerability, Effectiveness, and Pharmacokinetic Data in Opioid-experienced Children
|
Phase 3 | |
Completed |
NCT05607641 -
Efficacy and Safety Study of Ketorolac / Pitofenone / Fenpiverinium for the Treatment of Patients With Pain After Surgical Abdominal and Pelvic Operations
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT06202989 -
Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty
|
Phase 3 | |
Completed |
NCT01731730 -
Study to Evaluate Safety/Efficacy of a Single Pre-Op Dose of AYX1 Injection to Treat Pain After Knee Replacement Surgery
|
Phase 2 | |
Recruiting |
NCT05698914 -
Telehealth Mindfulness After Spine Surgery
|
N/A | |
Completed |
NCT04203537 -
Study Evaluating the Safety, Efficacy and Pharmacokinetics of CA-008 (Vocacapsaicin)
|
Phase 1/Phase 2 | |
Completed |
NCT04648683 -
Postoperative Telehealth Mindfulness Intervention After Spine Surgery
|
N/A | |
Completed |
NCT06412380 -
Influence of Insertion Torque and Bone Type on Post-operative Pain
|
N/A | |
Recruiting |
NCT05394402 -
A Trial of SHR0410 Injection in Postsurgical Pain Management
|
Phase 2 | |
Not yet recruiting |
NCT06344169 -
Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section
|
Phase 2/Phase 3 |