Long-term Durability Study of Collagenase Clostridium Histolyticum (CCH)
Launched by ENDO PHARMACEUTICALS · May 7, 2020
Trial Information
Current as of April 28, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • 1. Have participated in and completed studies EN3835-201, EN3835-202 and EN3835-219 and had composite improvement of at least 2 levels on both the CR-PCSS and PR-PCSS in study EN3835-201.
- • 2. Be willing and able to cooperate with the requirements of the study.
- Exclusion Criteria:
- • 1. Has had retreatment with CCH in the area initially treated during the EN3835-201 study since the completion of study EN3835-219.
- • 2. Has received collagenase treatments (eg, Santyl® Ointment and/or Xiaflex®/Xiapex®) since the completion of study EN3835-219.
- • 3. Has had liposuction on the body region treated during the EN3835-201 study since the completion of that study.
- • 4. Has had any surgery, invasive procedure (eg, liposuction), injectable treatment (eg, KYBELLA®) or any similar treatment in the area treated during the EN3835-201 study since the completion of that study.
- • 5. Has any other condition(s) that, in the investigator's opinion, might indicate the participant to be unsuitable for the study.
About Endo Pharmaceuticals
Endo Pharmaceuticals is a leading global pharmaceutical company focused on the development and commercialization of innovative therapies that improve patient outcomes. With a strong commitment to addressing unmet medical needs, Endo specializes in pain management, urology, and other therapeutic areas. The company leverages advanced research and development capabilities to bring forth a diverse portfolio of products, including both branded and generic medications. Endo's dedication to quality and patient safety is reflected in its rigorous clinical trial programs, aimed at providing effective and reliable solutions for healthcare providers and patients alike.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Clearwater, Florida, United States
Coral Gables, Florida, United States
Washington, Missouri, United States
New York, New York, United States
Patients applied
Trial Officials
Karen Chajko
Study Director
Endo Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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