At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
AA4500 0.29 mg/1 mL +4 morebiological
Likely dose
AA4500 0.29 mg/1 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2a, Open-label, Dose-ranging Study of the Safety and Effectiveness of AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder
In Brief
A Phase 2 clinical trial evaluating AA4500 0.29 mg/1 mL, AA4500 0.58 mg/2 mL, and 3 other interventions for Adhesive Capsulitis and Frozen Shoulder. Completed, enrolled 50 participants across 15 sites.
Detailed Summary
The objectives of this study are to assess the safety, effectiveness, and immunogenicity of AA4500 in the treatment of adhesive capsulitis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdhesive Capsulitis, Frozen Shoulder
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
First PostedDec 2011
Primary CompletionFeb 2013
TodayJul 2026
First PostedDec 2, 2011
Enrollment StartNov 1, 2011
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.6 years ago
Interventions
AA4500 0.29 mg/1 mLbiological
treatment of adhesive capsulitis
AA4500 0.58 mg/2 mLbiological
treatment of adhesive capsulitis
AA4500 0.58 mg/1 mLbiological
treatment of adhesive capsulitis
AA4500 0.58 mg/0.5 mLbiological
treatment of adhesive capsulitis
Shoulder exercisesother
Home shoulder exercises, minimum of 3 times per day