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Study to Evaluate EB-001 in Reducing Musculoskeletal Pain

23 de janeiro de 2019 atualizado por: 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

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

66

Estágio

  • Fase 2

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • California
      • Pasadena, California, Estados Unidos, 91105
        • Lotus Clinical Research

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 55 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição sequencial
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo Injections

Intervention: Drug: Placebo

Single Saline Injection into the Pectoralis Muscle

Placebo- Single injection of saline into Pectoralis Muscle
Comparador Ativo: 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
Comparador Ativo: 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
Comparador Ativo: 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
Comparador Ativo: 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
Comparador Ativo: 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
Comparador Ativo: 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

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Subject's Assessment of Pain Using the Numeric Pain Rating Scale (AUC16h-96h)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

29 de agosto de 2017

Conclusão Primária (Real)

26 de abril de 2018

Conclusão do estudo (Real)

7 de agosto de 2018

Datas de inscrição no estudo

Enviado pela primeira vez

19 de junho de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de junho de 2017

Primeira postagem (Real)

21 de junho de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

25 de janeiro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

23 de janeiro de 2019

Última verificação

1 de janeiro de 2019

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • EB001-MA201

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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