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COMPLETED Phase 2

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

NCT02193828 · View on ClinicalTrials.gov ↗

Study Summary

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

Conditions Studied

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

Sponsor

Endo Pharmaceuticals

23 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02193828

The ClinicalTrials.gov registry entry for NCT02193828 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 76 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endo Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02193828 reports 11 study locations spanning 8 distinct geographic areas — top geographies include California, Queensland, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02193828?

The interventions under investigation include: Placebo (BIOLOGICAL), Collagenase clostridium histolyticum (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02193828?

This trial is sponsored by Endo Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial