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AA4500 for Adhesive Capsulitis
NCT01483963Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2011
- Primary completion
- Feb 2013
- Countries
- 1
- Sponsor
- Endo International plc
- Modality
- Therapeutic Enzymes
- Conditions
- adhesive capsulitis (AC)
01
Overview
Phase 2, open-label trial of collagenase clostridium histolyticum in adhesive capsulitis (AC) (5 arms), sponsored by Endo International plc. Primary endpoint: Change From Baseline to Day 92 in Active Forward Flexion. Started Nov 2011; status: completed.
02
Design
5 arms- Study design
- Non-randomizedOpen-label
AA4500 0.29 mg/1 mL
Up to 3 injections of AA4500 0.29 mg/1 mL + exercises
AA4500 0.58 mg/2 mL
Up to 3 injections of AA4500 0.58 mg/2 mL + exercises
AA4500 0.58 mg/1 mL
Up to 3 injections of AA4500 0.58 mg/1 mL + exercises
AA4500 0.58 mg/0.5 mL
Up to 3 injections of AA4500 0.58 mg/0.5 mL + exercises
Shoulder exercises
Home shoulder exercises only
03
Who it enrols
Adults with unilateral idiopathic adhesive capsulitis (Stage 2) for 3-12 months with restricted range of motion. Excludes patients with uncontrolled diabetes, hypertension, or recent treatment for the condition.
04
Endpoints
Primary
Change From Baseline to Day 92 in Active Forward Flexion
Secondary
Change From Baseline to Day 92 in Passive Forward Flexion
Change From Baseline to Day 92 in Active Abduction
Change From Baseline to Day 92 in Passive Abduction
Change From Baseline to Day 92 in Active External Rotation
Change From Baseline to Day 92 in Passive External Rotation
Change From Baseline to Day 92 in Active Internal Rotation
Change From Baseline to Day 92 in Passive Internal Rotation
Change From Baseline to Day 92 in American Shoulder and Elbow Surgeons (ASES) Composite Score
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