Study to Evaluate EB-001 in Reducing Musculoskeletal Pain

Musculoskeletal Pain Clinical Trial

Official title: Phase 2 Placebo-Controlled, Double Blind, Ascending Dose Cohort Study to Evaluate Safety and Efficacy of EB-001 IM Injections in Reducing Musculoskeletal Pain in Subjects Undergoing Elective Augmentation Mammoplasty (Breast Augmentation)

Status Completed

Clinical Trial Summary

To determine the safety and efficacy of single intra-operative treatment of EB-001 IM injections into the Pectoralis Major (PM) in subjects undergoing breast augmentation with subpectoral implants

Clinical Trial Description

This study will evaluate the safety and efficacy of EB-001 in decreasing post-surgical pain in patients undergoing surgical breast augmentation with subpectoral placement of the implants. Intramuscular (IM) injection of EB-001 into the PM bilaterally during surgery may decrease pain related to stretching of the PM by the implants.

The safety objective is to determine the safety and tolerability of single intraoperative treatment of EB-001 IM injections into the PM in subjects undergoing breast augmentation with subpectoral implants.

The efficacy objective is to evaluate the efficacy of intraoperative administration of EB-001 IM into the PM in reducing the pain and use of rescue pain medications in subjects undergoing breast augmentation with subpectoral implants. ;

Related Conditions & MeSH terms

• Musculoskeletal Pain

• NCT number: NCT03193593
• Study type: Interventional
• Source: Bonti, Inc.
• Status: Completed
• Phase: Phase 2
• Start date: August 29, 2017
• Completion date: August 7, 2018