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NCT02193828 · ClinicalTrials.gov registry record · Phase 2

Phase 2a Dose-Ranging Study to Evaluate Safety and Effectiveness of AA4500 in Treatment of Dupuytren's Disease Nodules

A Phase 2 study of Dupuytren's Disease, sponsored by Endo Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
76
Enrollment target
11
Study locations

NCT02193828: Completed Phase 2 study of Dupuytren's Disease, sponsored by Endo Pharmaceuticals.

NCT02193828 is a Phase 2 study of Dupuytren's Disease that has completed, run by Endo Pharmaceuticals. The registered enrollment target is 76 participants, above the 43-participant average among 4 other Dupuytren's Disease trials with a reported enrollment target (77% higher). The trial reports 11 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02193828, a Phase 2 study of Dupuytren's Disease, has completed, sponsored by Endo Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
76 participants
Enrollment target
11
Study locations

Study Summary

The objectives of this study are to assess the safety and effectiveness of AA4500 in treating palmar Dupuytren's disease nodules.

Primary Outcome

Percent change from baseline in surface area and volume of the treated nodule was determined from hand-held caliper measurements of the length and width of the nodule. Percent change = 100\*(Day 57 area \[or volume\] - baseline area \[or volume\])/baseline area \[or volume\]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening.

Conditions Studied

Dupuytren's Disease

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL Collagenase clostridium histolyticum

Study Locations (11)

California

  • CORE Orthopaedic Medical Center - Encinitas
  • Marin Endocrine Care & Research, Inc. - Greenbrae
  • Brigid Freyne, MD, Inc. - Murrieta

Queensland

  • Brisbane Hand & Upper Limb Clinic - Brisbane
  • Houston Medical - Kippa-Ring

Arizona

  • Tucson Orthopaedic Institute - Tucson

Indiana

  • Indiana Hand to Shoulder Center - Indianapolis

New York

  • State University of New York - Stony Brook

North Carolina

  • OrthoCarolina Research Institute, Inc. - Charlotte

Oklahoma

  • Orthopedic and Reconstructive Center - Oklahoma City

Pennsylvania

  • Blair Orthopedic Associates, Inc. - Altoona

Trial Details

FieldValue
Enrollment Target 76 participants
Start Date 2014-07
Est. Completion 2014-12
Phase Phase 2
Endo Pharmaceuticals

23 total trials

What the finished NCT02193828 record still lists

NCT02193828 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 43-participant average among 4 other Dupuytren's Disease trials with a reported enrollment target (77% higher).

The record links to 1 condition, with Dupuytren's Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02193828 lists 11 locations in 8 states (California, Queensland, Arizona).

Frequently Asked Questions

What is clinical trial NCT02193828 about?

NCT02193828 is a clinical study titled "Phase 2a Dose-Ranging Study to Evaluate Safety and Effectiveness of AA4500 in Treatment of Dupuytren's Disease Nodules". The objectives of this study are to assess the safety and effectiveness of AA4500 in treating palmar Dupuytren's disease nodules.

What is the current status of trial NCT02193828?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2014-07. Estimated completion is 2014-12.

What conditions does trial NCT02193828 study?

This clinical trial studies the following conditions: Dupuytren's Disease.

What interventions are being tested in trial NCT02193828?

The interventions under investigation include: Placebo (BIOLOGICAL), Collagenase clostridium histolyticum (BIOLOGICAL).

Who is sponsoring clinical trial NCT02193828?

This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02193828 being conducted?

This trial has 11 study locations across Arizona, California, Indiana, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT02193828, the US trial registry maintained by the National Library of Medicine. NCT02193828 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.