NCT03193593

Study to Evaluate EB-001 in Reducing Musculoskeletal Pain

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Bonti, Inc. · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Musculoskeletal Pain

Interventions

Type	Name	Description
DRUG	Placebo	Placebo- Single injection of saline into Pectoralis Muscle
DRUG	EB-001	Single injection of EB-001 into Pectoralis Muscle

Timeline

• Start date: 2017-08-29
• Primary completion: 2018-04-26
• Completion: 2018-08-07
• First posted: 2017-06-21
• Last updated: 2019-01-25
• Results posted: 2019-01-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study