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Study to Evaluate EB-001 in Reducing Musculoskeletal Pain

NCT03193593 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2019-01-25

Study results available
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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

Conditions

Interventions

DRUG

Placebo

Placebo- Single injection of saline into Pectoralis Muscle

DRUG

EB-001

Single injection of EB-001 into Pectoralis Muscle

Sponsors & Collaborators

  • Bonti, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-29
Primary Completion
2018-04-26
Completion
2018-08-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03193593 on ClinicalTrials.gov