CompletedPhase 2

Study to Evaluate EB-001 in Reducing Musculoskeletal Pain

United States66 participantsStarted 2017-08-29

Plain-language 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

Who can participate

Age range18 Years – 55 Years

SexFEMALE

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Inclusion criteria

✓. Women 18 to 55 years of age, inclusive
✓. Women who are in 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 (endotracheal or otherwise) with:
✓. Sub-pectoral implants placement,
✓. Infra-mammary surgical approach,
✓. Implant size between 250 and 400cc and
✓. Non-textured saline breast implants
✓. American Society of Anesthesiologist (ASA) Physical Class 1-2

Exclusion criteria

✕. History of surgical procedure involving the breast, including, but not limited to, breast augmentation. History of minor localized breast biopsy is not exclusionary if it occurred at least 1 year prior to the screening visit, and if considered not clinically significant in the opinion of the investigator.
✕. Pre-existing lung disease that could impact subject safety in the opinion of the investigator
✕. History of smoking within the past two years
✕. Slow vital capacity that is below 80% of normal value for respective race, age, height, and gender
✕. Pulse oximetry below 95%
✕. Body weight less than 50 kg (110 pounds) or a Body Mass Index (BMI) of ≥ 32
✕. Documented diagnosis of chronic pain condition, or other painful pre-operative condition that, in the opinion of the investigator, may require analgesic treatment in the post-operative period (e.g. significant joint pain, neuropathic pain)
✕. Known hypersensitivity to any botulinum toxin serotype or to any component of the formulation

What they're measuring

Subject's Assessment of Pain Using the Numeric Pain Rating Scale (AUC16h-96h)

Timeframe: 16 hours to 96 hours following dosing

Trial details

NCT IDNCT03193593

SponsorBonti, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-04-26

Results submitted2018-10-17

View on ClinicalTrials.gov More Musculoskeletal Pain trials