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Longterm Observational Study in Subjects Treated With AA4500 in AUX-CC-854, 856, 857, 858 & 859
This study has been completed.
Sponsor:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00954746
First received: August 6, 2009
Last updated: June 12, 2015
Last verified: June 2015
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Purpose
The purpose of study AUX-CC-860 is to assess the durability of response of the AA4500 treatment regimen. This study will also evaluate long-term safety and progression of disease in joints.
| Condition |
|---|
| Dupuytren's Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | CORDLESS- Collagenase Optimal Reduction of Dupuytren's - Long-term Evaluation of Success Study |
Resource links provided by NLM:
Further study details as provided by Endo Pharmaceuticals:
Primary Outcome Measures:
- Contracture Measurements [ Time Frame: yearly ]
Secondary Outcome Measures:
- Immunogenicity, concomitant medications, medical history, and adverse events [ Time Frame: yearly ]
Biospecimen Retention: Samples Without DNA
serum
| Enrollment: | 645 |
| Study Start Date: | July 2009 |
| Study Completion Date: | May 2013 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Follow-up
Subjects Previously Treated with AA4500
|
Detailed Description:
Phase 3 non-treatment study in which Year 2 to Year 5 year follow-up of subjects who received AA4500 in the 9-month open-label studies (AUX-CC-854 and AUX-CC-856) or the 12-month double-blind with open-label extension studies (AUX-CC-857/AUX-CC-858 and AUX-CC-859). After completion of one of the above mentioned studies, subjects are enrolled and followed once a calendar year for 4 consecutive years with at least 6 months between consecutive visits.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Subjects with Advanced Dupuytren's Disease Previously Treated with AA4500 in Studies AUX-CC-854, AUX-CC-856, AUX-CC-857/AUX-CC-858, and AUX-CC-859
Criteria
Inclusion Criteria:
To be eligible for this study a subject had to:
- Have received at least one injection of AA4500 in one of the Auxilium sponsored studies (AUX-CC-854, AUX-CC-856, Studies AUX-CC-857/AUX-CC-858, or AUX-CC-859) and have at least one fixed-flexion contracture measurement after treatment with AA4500
- Be able and willing to comply with the yearly assessments outlined in the protocol, as determined by the investigator
- Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC)
Exclusion Criteria:
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00954746
Show 39 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954746
Show 39 Study Locations
Sponsors and Collaborators
Endo Pharmaceuticals
Investigators
| Study Director: | Veronica Urdaneta, MD | Endo Health Solutions |
More Information
Additional Information:
| Responsible Party: | Endo Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00954746 History of Changes |
| Other Study ID Numbers: |
AUX-CC-860 |
| Study First Received: | August 6, 2009 |
| Last Updated: | June 12, 2015 |
Keywords provided by Endo Pharmaceuticals:
|
Advanced Dupuytren's Disease Muscular Diseases Musculoskeletal Diseases |
Contracture Joint Diseases Connective Tissue Diseases Dupuytren's Contracture |
Additional relevant MeSH terms:
|
Dupuytren Contracture Contracture Muscular Diseases Musculoskeletal Diseases Connective Tissue Diseases |
ClinicalTrials.gov processed this record on June 23, 2017