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AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder

NCT01483963 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-10-05

Study results available
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Summary

The objectives of this study are to assess the safety, effectiveness, and immunogenicity of AA4500 in the treatment of adhesive capsulitis.

Conditions

  • Adhesive Capsulitis
  • Frozen Shoulder

Interventions

BIOLOGICAL

AA4500 0.29 mg/1 mL

treatment of adhesive capsulitis

BIOLOGICAL

AA4500 0.58 mg/2 mL

treatment of adhesive capsulitis

BIOLOGICAL

AA4500 0.58 mg/1 mL

treatment of adhesive capsulitis

BIOLOGICAL

AA4500 0.58 mg/0.5 mL

treatment of adhesive capsulitis

OTHER

Shoulder exercises

Home shoulder exercises, minimum of 3 times per day

Sponsors & Collaborators

  • Endo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Neil H Shusterman, MD FACP · Endo Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01483963 on ClinicalTrials.gov