이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Study to Evaluate EB-001 in Reducing Musculoskeletal Pain

2019년 1월 23일 업데이트: Bonti, Inc.

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)

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

연구 개요

상태

완전한

상세 설명

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.

연구 유형

중재적

등록 (실제)

66

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • California
      • Pasadena, California, 미국, 91105
        • Lotus Clinical Research

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

설명

Inclusion Criteria:

  1. Women 18 to 55 years of age, inclusive
  2. Women who are in good health as determined by medical history, physical examination, clinical laboratory studies, ECGs, vital signs, and Investigator judgment
  3. Scheduled to undergo primary breast augmentation under general anesthesia (endotracheal or otherwise) with:

    1. Sub-pectoral implants placement,
    2. Infra-mammary surgical approach,
    3. Implant size between 250 and 400cc and
    4. Non-textured saline breast implants
  4. American Society of Anesthesiologist (ASA) Physical Class 1-2
  5. Women of non-childbearing potential or postmenopausal (at least 12 consecutive months of amenorrhea)
  6. Women of childbearing potential must not be pregnant, lactating, or planning to become pregnant during the study
  7. Women of childbearing potential agreeing to use either:

    1. a highly effective method of contraception with failures rates less than 1% per year such as implant, intrauterine device (IUD), or confirmed sterilization and sterilization procedure at least 3 months prior to the day of dosing
    2. dual methods of contraception with overall failures rate less than 1% per year such as injectable, pill, patch, ring, and diaphragm from the day of dosing for 3 months (subjects using oral contraception must have initiated treatment at least 2 months prior to the day of dosing)
  8. Willing and able to complete protocol requirements and instructions, which includes completion of all required visits, procedures and in-clinic stays until the end of the study
  9. Willing and able to sign and date IRB-approved informed consent
  10. Able to speak, read, and understand the language of the informed consent form (ICF) and study questionnaires

Exclusion Criteria:

  1. 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.
  2. Pre-existing lung disease that could impact subject safety in the opinion of the investigator
  3. History of smoking within the past two years
  4. Slow vital capacity that is below 80% of normal value for respective race, age, height, and gender
  5. Pulse oximetry below 95%
  6. Body weight less than 50 kg (110 pounds) or a Body Mass Index (BMI) of ≥ 32
  7. 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)
  8. Known hypersensitivity to any botulinum toxin serotype or to any component of the formulation
  9. Reported use of any botulinum toxin within 3 months prior to the date of surgery
  10. Anticipated use of any botulinum toxin of any serotype during the study
  11. Use of long acting opioids within 3 days or any opioid medication within 24 hours prior to surgery
  12. Aminoglycoside intake within 48 hours prior to or during surgery
  13. Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton- Lambert syndrome, or amyotrophic lateral Sclerosis)
  14. Any past or current medical condition that in opinion of investigator, puts subject at undue safety risk for surgical complications or for use of the investigational product.
  15. Any clinically significant psychiatric condition that, in opinion of investigator, may interfere with study assessments or protocol compliance
  16. History of alcohol or drug abuse in the last 3 years, based on investigator judgement
  17. Current enrollment in an investigational drug or device study or participation in such a study within 30 days or 5 half-lives of the drug, whichever is longer, of entry into this study
  18. Subject plans to donate blood or plasma from 30 days prior to screening until last follow-up visit (Day 29)
  19. Reported pain score of 2 or more at screening on the 11-point scale NPRS-A following strength testing with PM activation

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 순차적 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: Placebo Injections

Intervention: Drug: Placebo

Single Saline Injection into the Pectoralis Muscle

Placebo- Single injection of saline into Pectoralis Muscle
활성 비교기: EB-001 Dose 1

Intervention: Drug: EB-001

1st Dose in escalation paradigm. Single Injection of active drug into the pectoralis muscle

Single injection of EB-001 into Pectoralis Muscle
활성 비교기: EB-001 Dose 2 (1.6X)

Intervention: Drug: EB-001

2nd Dose in escalation paradigm, 1.6X Dose 1. Single Injection of active drug into the pectoralis muscle

Single injection of EB-001 into Pectoralis Muscle
활성 비교기: EB-001 Dose 3 (3.3X)

Intervention: Drug: EB-001

3rd Dose in escalation paradigm, 3.3X Dose 1. Single Injection of active drug into the pectoralis muscle

Single injection of EB-001 into Pectoralis Muscle
활성 비교기: EB-001 Dose 4 (6.7X)

Intervention: Drug: EB-001

4th Dose in escalation paradigm, 6.7X Dose 1. Single Injection of active drug into the pectoralis muscle

Single injection of EB-001 into Pectoralis Muscle
활성 비교기: EB-001 Dose 5 (10X)

Intervention: Drug: EB-001

5th Dose in escalation paradigm, 10X Dose 1. Single Injection of active drug into the pectoralis muscle

Single injection of EB-001 into Pectoralis Muscle
활성 비교기: EB-001 Dose 6 (13.3X)

Intervention: Drug: EB-001

6th Dose in escalation paradigm, 13.3X Dose 1. Single Injection of active drug into the pectoralis muscle

Single injection of EB-001 into Pectoralis Muscle

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Subject's Assessment of Pain Using the Numeric Pain Rating Scale (AUC16h-96h)
기간: 16 hours to 96 hours following dosing
Subject's assessment of pain using the Numeric Pain Rating Scale (1= No Pain, 10= Maximum Pain) for the first 96 hours following injection, expressed as AUC over the 16h to 96h period following dosing.
16 hours to 96 hours following dosing

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2017년 8월 29일

기본 완료 (실제)

2018년 4월 26일

연구 완료 (실제)

2018년 8월 7일

연구 등록 날짜

최초 제출

2017년 6월 19일

QC 기준을 충족하는 최초 제출

2017년 6월 20일

처음 게시됨 (실제)

2017년 6월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 1월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 1월 23일

마지막으로 확인됨

2019년 1월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • EB001-MA201

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

근골격계 통증에 대한 임상 시험

Placebo에 대한 임상 시험

구독하다