Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03789318
Study type Interventional
Source Concentric Analgesics
Contact
Status Completed
Phase Phase 2
Start date December 3, 2018
Completion date June 12, 2019

See also
  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