CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 66 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Single injection of EB-001 into Pectoralis Muscle (dose not specified in ascending dose cohort study)AI-extracted
Key inclusion· 6
  • ✓Women 18 to 55 years of age, inclusive
  • ✓Good health as determined by medical history, physical examination, clinical laboratory studies, ECGs, vital signs, and Investigator judgment
  • ✓Scheduled to undergo primary breast augmentation under general anesthesia with sub-pectoral implants, infra-mammary approach, implant size 250–400 cc, and non-textured saline implants
  • ✓ASA Physical Class 1–2
Key exclusion· 13
  • ✕History of any prior breast surgical procedure, including breast augmentation (minor localized breast biopsy >1 year prior is allowed if clinically insignificant)
  • ✕Pre-existing lung disease that could impact subject safety
  • ✕Smoking within the past two years
  • ✕Slow vital capacity below 80% of normal value for respective race, age, height, and gender

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03193593
NCT03193593Phase 2Completed
CompareCT.gov

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)

Bonti, Inc.·interventional·Posted Jun 21, 2017·Updated Jan 25, 2019

In Brief

A Phase 2 clinical trial evaluating Placebo and EB-001 for Musculoskeletal Pain. Completed, enrolled 66 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMusculoskeletal Pain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 21, 2017
Enrollment StartAug 29, 2017
Primary CompletionApr 26, 2018
Study CompletionAug 7, 2018
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 9.0 years ago

Interventions

Placebodrug

Placebo- Single injection of saline into Pectoralis Muscle

EB-001drug

Single injection of EB-001 into Pectoralis Muscle