Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder

7. September 2017 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

50

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Alabama
      • Birmingham, Alabama, Vereinigte Staaten, 35209
        • Alabama Orthopaedic Center - Research
    • Arizona
      • Phoenix, Arizona, Vereinigte Staaten, 85050
        • Hope Research Institute
      • Tucson, Arizona, Vereinigte Staaten, 85712
        • Tucson Orthopaedic Institute
    • Arkansas
      • Little Rock, Arkansas, Vereinigte Staaten, 72205
        • OrthoArkansas
    • California
      • Encinitas, California, Vereinigte Staaten, 92024
        • CORE Orthopaedic Medical Center
      • La Mesa, California, Vereinigte Staaten, 91942
        • TriWest Research Associates
    • Florida
      • Pinellas Park, Florida, Vereinigte Staaten, 33781
        • Advent Clinical Research
    • Illinois
      • Rockford, Illinois, Vereinigte Staaten, 61107
        • Rockford Orthopedic Associates
    • Indiana
      • Indianapolis, Indiana, Vereinigte Staaten, 46260
        • The Indiana Hand to Shoulder Center
    • New York
      • Stony Brook, New York, Vereinigte Staaten, 11794
        • Stony Brook University Medical Center
    • Ohio
      • Cleveland, Ohio, Vereinigte Staaten, 44143
        • David R. Mandel, MD, Inc.
    • Oklahoma
      • Oklahoma City, Oklahoma, Vereinigte Staaten, 73109
        • Health Research Institute
    • Pennsylvania
      • Altoona, Pennsylvania, Vereinigte Staaten, 16602
        • Blair Orthopedic Associates, Inc.
    • Tennessee
      • Clarksville, Tennessee, Vereinigte Staaten, 37043
        • Alpha Clinical Research, LLC
    • Texas
      • Odessa, Texas, Vereinigte Staaten, 79761
        • Basin Orthopedic Surgical Specialists

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  1. Be a male or female and be greater than or equal to 18 years of age
  2. 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
  3. 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
  4. Have normal range of motion in the contralateral shoulder, as determined by the investigator

  5. 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
  6. 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.
  7. Be able to complete and understand the various rating instruments in English.

Exclusion Criteria:

  1. Is a pregnant or lactating female or female intending to become pregnant during the study
  2. Is a male who intends to father a child during the study

  3. 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

  4. 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
  5. Is unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits.
  6. Has received oral or intravenous steroids for any reason within 3 weeks before the screening visit
  7. Has received an investigational drug or treatment within 30 days before the first dose of study drug.
  8. Has a known systemic allergy to collagenase or any other excipient of AA4500 or any other procedural medication.
  9. Has, at any time, received collagenase for the treatment of adhesive capsulitis.
  10. Is unable to undergo an x-ray or MRI (contraindication) evaluation of the affected shoulder.
  11. Is planning to be treated with commercial Xiaflex at any time during the study.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: AA4500 0.29 mg/1 mL
Up to three injections
Biologisch: AA4500 0.29 mg/1 mL
treatment of adhesive capsulitis
Andere Namen:
  • Kollagenase Clostridium histolyticum
  • XIAFLEX
  • XIAPEX
Sonstiges: Shoulder exercises
Home shoulder exercises, minimum of 3 times per day
Experimental: AA4500 0.58 mg/2 mL
Up to three injections
Sonstiges: Shoulder exercises
Home shoulder exercises, minimum of 3 times per day
Biologisch: AA4500 0.58 mg/2 mL
treatment of adhesive capsulitis
Andere Namen:
  • Kollagenase Clostridium histolyticum
  • XIAFLEX
  • XIAPEX
Experimental: AA4500 0.58 mg/1 mL
Up to three injections
Sonstiges: Shoulder exercises
Home shoulder exercises, minimum of 3 times per day
Biologisch: AA4500 0.58 mg/1 mL
treatment of adhesive capsulitis
Andere Namen:
  • Kollagenase Clostridium histolyticum
  • XIAFLEX
  • XIAPEX
Experimental: AA4500 0.58 mg/0.5 mL
Up to three injections
Sonstiges: Shoulder exercises
Home shoulder exercises, minimum of 3 times per day
Biologisch: AA4500 0.58 mg/0.5 mL
treatment of adhesive capsulitis
Andere Namen:
  • Kollagenase Clostridium histolyticum
  • XIAFLEX
  • XIAPEX
Sonstiges: Shoulder exercises
Home shoulder exercises for 64 days
Sonstiges: Shoulder exercises
Home shoulder exercises, minimum of 3 times per day

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline to Day 92 in Active Forward Flexion
Zeitfenster: Baseline, Day 92
Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder
Baseline, Day 92

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline to Day 92 in Passive Forward Flexion
Zeitfenster: Baseline, Day 92
Passive range of motion (PROM) measurement using a goniometer to assess forward flexion in the affected shoulder
Baseline, Day 92
Change From Baseline to Day 92 in Active Abduction
Zeitfenster: Baseline, Day 92
AROM measurement using a goniometer to assess abduction in the affected shoulder
Baseline, Day 92
Change From Baseline to Day 92 in Passive Abduction
Zeitfenster: Baseline, Day 92
PROM measurement using a goniometer to assess abduction in the affected shoulder
Baseline, Day 92
Change From Baseline to Day 92 in Active External Rotation
Zeitfenster: Baseline, Day 92
AROM measurement using a goniometer to assess external rotation in the affected shoulder
Baseline, Day 92
Change From Baseline to Day 92 in Passive External Rotation
Zeitfenster: Baseline, Day 92
PROM measurement using a goniometer to assess external rotation in the affected shoulder
Baseline, Day 92
Change From Baseline to Day 92 in Active Internal Rotation
Zeitfenster: Baseline, Day 92
AROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder
Baseline, Day 92
Change From Baseline to Day 92 in Passive Internal Rotation
Zeitfenster: Baseline, Day 92
PROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder
Baseline, Day 92
Change From Baseline to Day 92 in American Shoulder and Elbow Surgeons (ASES) Composite Score
Zeitfenster: 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
Baseline, Day 92
Change From Baseline to Day 92 in ASES Pain Subscale
Zeitfenster: 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
Baseline, Day 92
Change From Baseline to Day 92 in ASES Function Subscale
Zeitfenster: 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
Baseline, Day 92
Subject Satisfaction With Treatment at Day 92
Zeitfenster: Day 92
Participant assessment of satisfaction with treatment rated as very satisfied, quite satisfied, neither satisfied nor dissatisfied, quite dissatisfied, or very dissatisfied.
Day 92
Investigator Assessment of Improvement With Treatment at Day 92
Zeitfenster: Day 92
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.
Day 92

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Endo Pharmaceuticals

Ermittler

  • Studienleiter: Neil H Shusterman, MD FACP, Endo Pharmaceuticals

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. November 2011

Primärer Abschluss (Tatsächlich)

1. Februar 2013

Studienabschluss (Tatsächlich)

1. Februar 2013

Studienanmeldedaten

Zuerst eingereicht

30. November 2011

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

1. Dezember 2011

Zuerst gepostet (Schätzen)

2. Dezember 2011

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Oktober 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. September 2017

Zuletzt verifiziert

1. September 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • AUX-CC-870

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Klebstoff capsulitis

Klinische Studien zur AA4500 0.29 mg/1 mL

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Macedonia

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren