AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder
7 de setembro de 2017 atualizado por: Endo Pharmaceuticals
A Phase 2a, Open-label, Dose-ranging Study of the Safety and Effectiveness of AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder
The objectives of this study are to assess the safety, effectiveness, and immunogenicity of AA4500 in the treatment of adhesive capsulitis.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
This study is a Phase 2a, open-label, dose-ranging study of the safety and effectiveness of AA4500 for the treatment of adhesive capsulitis of the shoulder. To be eligible for treatment, a subject must have unilateral idiopathic adhesive capsulitis of the shoulder with restricted range of motion in the affected shoulder for at least 3 months but not more than 12 months. Subjects will be screened for study eligibility within 30 days before injection of study drug.
Approximately 50 adult women and men are to be enrolled in this study. Following screening and determination of study eligibility, Assignment to Cohorts 1-4 is sequential. Subjects assigned to Cohorts 1 through 4 may receive up to 3 injections of AA4500 according to cohort assignment. Each injection will be separated by a minimum of 21 days. Subjects assigned to Cohort 5 will receive home shoulder exercises only, while subjects assigned to Cohorts 1-4 will receive AA4500 and home shoulder exercises. Subjects in Cohort 5 will be offered physical therapy sessions for a period of 2 months following completion of the study.
Dosing will range from 0.29 mg to 0.58 mg with varying volumes.
Tipo de estudo
Intervencional
Inscrição (Real)
50
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
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Alabama
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Birmingham, Alabama, Estados Unidos, 35209
- Alabama Orthopaedic Center - Research
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Arizona
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Phoenix, Arizona, Estados Unidos, 85050
- HOPE Research Institute
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Tucson, Arizona, Estados Unidos, 85712
- Tucson Orthopaedic Institute
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Arkansas
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Little Rock, Arkansas, Estados Unidos, 72205
- OrthoArkansas
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California
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Encinitas, California, Estados Unidos, 92024
- CORE Orthopaedic Medical Center
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La Mesa, California, Estados Unidos, 91942
- TriWest Research Associates
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Florida
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Pinellas Park, Florida, Estados Unidos, 33781
- Advent Clinical Research
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Illinois
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Rockford, Illinois, Estados Unidos, 61107
- Rockford Orthopedic Associates
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46260
- The Indiana Hand to Shoulder Center
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New York
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Stony Brook, New York, Estados Unidos, 11794
- Stony Brook University Medical Center
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Ohio
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Cleveland, Ohio, Estados Unidos, 44143
- David R. Mandel, MD, Inc.
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos, 73109
- Health Research Institute
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Pennsylvania
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Altoona, Pennsylvania, Estados Unidos, 16602
- Blair Orthopedic Associates, Inc.
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Tennessee
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Clarksville, Tennessee, Estados Unidos, 37043
- Alpha Clinical Research, LLC
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Texas
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Odessa, Texas, Estados Unidos, 79761
- Basin Orthopedic Surgical Specialists
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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 e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Be a male or female and be greater than or equal to 18 years of age
- If a female of childbearing potential, have a negative urine pregnancy test and be using an effective contraception method (ie, abstinence, intrauterine device (IUD), hormonal (estrogen/progestin) contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for one menstrual cycle following end of study, or be surgically sterile
- Have unilateral idiopathic adhesive capsulitis of one shoulder for at least 3 months but not more than 12 months before the screening visit and be in Stage 2 (frozen or adhesive stage), as determined by the investigator
- Have normal range of motion in the contralateral shoulder, as determined by the investigator
Have restricted active range of motion (AROM) in the affected shoulder defined as: a deficit of at least 60 degrees in total AROM in the affected shoulder as compared with the total AROM in the contralateral shoulder and a deficit of at least 30 degrees in AROM in at least one of the following planes as compared with the contralateral shoulder:
- Forward flexion
- Abduction
- External rotation with the elbow up to 90 degrees abduction
- Internal rotation with the elbow up to 90 degrees abduction
- Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must also sign an authorization form to allow disclosure of his protected health information (PHI). The PHI authorization form and informed consent form may be an integrated form or may be separate forms depending on the institution.
- Be able to complete and understand the various rating instruments in English.
Exclusion Criteria:
- Is a pregnant or lactating female or female intending to become pregnant during the study
- Is a male who intends to father a child during the study
Has received treatment for adhesive capsulitis or is planning to receive treatment for adhesive capsulitis at any time during the study including but not limited to:
- physical therapy or acupuncture within 2 weeks before the first injection of AA4500
- intra-articular or intrabursal injection(s) of lidocaine; suprascapular nerve blocks; corticosteroids; electroanalgesic and/or thermoanalgesic modalities within 1 month before the screening visit
- intra-articular or intrabursal injection(s) of sodium hyaluronate within 3 months before the screening visit
- glenohumeral distension arthrography and/or surgical intervention (including shoulder manipulation under anesthesia) at any time
Has any of the following conditions, as determined by the investigator:
- Adhesive capsulitis as a result of traumatic injury
- Pain in the affected shoulder at rest that is greater than or equal to 4 on the 11-point pain scale
- Active subacromial impingement in the affected shoulder
- Calcified tendonitis in the affected shoulder
- Glenohumeral joint arthritis in the affected shoulder
- Arthrosis of the affected shoulder
- Chondrolysis of the affected shoulder
- Subscapularis tendon rupture of the affected shoulder
- Other rotator cuff injuries of the affected shoulder
- Uncontrolled hypertension
- Uncontrolled diabetes
- Uncontrolled thyroid disease
- History of thrombosis or post-thrombosis syndrome
- Physical impairment that would preclude performing the protocol defined exercises
- Active infection in area to be treated
- Clinically significant neurological disease
- Coagulation disorder, using anticoagulant (except for less than or equal to 150 mg aspirin) within 7 days prior to each injection day
- Known active hepatitis B or C (history of hepatitis A permitted)
- Other significant medical condition (eg, morbid obesity, cervical disc disease), which in the investigator's opinion would make the subject unsuitable for enrollment in the study
- Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits.
- Has received oral or intravenous steroids for any reason within 3 weeks before the screening visit
- Has received an investigational drug or treatment within 30 days before the first dose of study drug.
- Has a known systemic allergy to collagenase or any other excipient of AA4500 or any other procedural medication.
- Has, at any time, received collagenase for the treatment of adhesive capsulitis.
- Is unable to undergo an x-ray or MRI (contraindication) evaluation of the affected shoulder.
- Is planning to be treated with commercial Xiaflex at any time during the study.
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 Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: AA4500 0.29 mg/1 mL
Up to three injections
|
treatment of adhesive capsulitis
Outros nomes:
Home shoulder exercises, minimum of 3 times per day
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Experimental: AA4500 0.58 mg/2 mL
Up to three injections
|
Home shoulder exercises, minimum of 3 times per day
treatment of adhesive capsulitis
Outros nomes:
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Experimental: AA4500 0.58 mg/1 mL
Up to three injections
|
Home shoulder exercises, minimum of 3 times per day
treatment of adhesive capsulitis
Outros nomes:
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Experimental: AA4500 0.58 mg/0.5 mL
Up to three injections
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Home shoulder exercises, minimum of 3 times per day
treatment of adhesive capsulitis
Outros nomes:
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Outro: Shoulder exercises
Home shoulder exercises for 64 days
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Home shoulder exercises, minimum of 3 times per day
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline to Day 92 in Active Forward Flexion
Prazo: Baseline, Day 92
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Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder
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Baseline, Day 92
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline to Day 92 in Passive Forward Flexion
Prazo: Baseline, Day 92
|
Passive range of motion (PROM) measurement using a goniometer to assess forward flexion in the affected shoulder
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Baseline, Day 92
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Change From Baseline to Day 92 in Active Abduction
Prazo: Baseline, Day 92
|
AROM measurement using a goniometer to assess abduction in the affected shoulder
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Baseline, Day 92
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Change From Baseline to Day 92 in Passive Abduction
Prazo: Baseline, Day 92
|
PROM measurement using a goniometer to assess abduction in the affected shoulder
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Baseline, Day 92
|
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Change From Baseline to Day 92 in Active External Rotation
Prazo: Baseline, Day 92
|
AROM measurement using a goniometer to assess external rotation in the affected shoulder
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Baseline, Day 92
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Change From Baseline to Day 92 in Passive External Rotation
Prazo: Baseline, Day 92
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PROM measurement using a goniometer to assess external rotation in the affected shoulder
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Baseline, Day 92
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Change From Baseline to Day 92 in Active Internal Rotation
Prazo: Baseline, Day 92
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AROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder
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Baseline, Day 92
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Change From Baseline to Day 92 in Passive Internal Rotation
Prazo: Baseline, Day 92
|
PROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder
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Baseline, Day 92
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Change From Baseline to Day 92 in American Shoulder and Elbow Surgeons (ASES) Composite Score
Prazo: Baseline, Day 92
|
Composite score ranging from 0-100, with 0 being worst pain and function loss, derived from the sum of the scores from pain subscale (11-point NRS where 0=no pain at all and 10=pain) and function subscale (activity questionnaire where 0=unable to do to, 1=very difficult to do, 2=somewhat difficult, and 3=not difficult); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation
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Baseline, Day 92
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Change From Baseline to Day 92 in ASES Pain Subscale
Prazo: Baseline, Day 92
|
Pain subscale score ranging from 0-50, with 0 being greatest pain, derived from participant assessment of pain in response to "How bad is the pain in your affected shoulder today?" on an 11-point numerical rating scale (NRS) where 0=no pain at all and 10=pain as bad as it can be and calculated as (10 - NRS score) x 5); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation
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Baseline, Day 92
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Change From Baseline to Day 92 in ASES Function Subscale
Prazo: Baseline, Day 92
|
Function subscale score ranging from 0-50, with 0 being most dysfunctional, derived from participant assessment of ability to do 10 activities with affected shoulder/arm where 0=unable to do to, 1=very difficult to do, 2=somewhat difficult, and 3=not difficult, and calculated as (cumulative total score for the 10 activity items) × (5/3); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation
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Baseline, Day 92
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Subject Satisfaction With Treatment at Day 92
Prazo: Day 92
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Participant assessment of satisfaction with treatment rated as very satisfied, quite satisfied, neither satisfied nor dissatisfied, quite dissatisfied, or very dissatisfied.
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Day 92
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Investigator Assessment of Improvement With Treatment at Day 92
Prazo: Day 92
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Investigator assessment of degree of improvement in severity of the participant's treated shoulder compared with screening rated as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
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Day 92
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Neil H Shusterman, MD FACP, Endo Pharmaceuticals
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
1 de novembro de 2011
Conclusão Primária (Real)
1 de fevereiro de 2013
Conclusão do estudo (Real)
1 de fevereiro de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
30 de novembro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de dezembro de 2011
Primeira postagem (Estimativa)
2 de dezembro de 2011
Atualizações de registro de estudo
Última Atualização Postada (Real)
5 de outubro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de setembro de 2017
Última verificação
1 de setembro de 2017
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AUX-CC-870
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 .