MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex

NCT01450397 | Completed Phase 4 Results

• 1 other identifier: 11052
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.

Conditions

Dupuytren's Disease

Keywords

Dupuytren's Contracture

Outcome Measures

Primary Outcomes (1)

• The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation.

  Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation.

  Baseline and 30 days

Study Arms (1)

XIAFLEX

OTHER

XIAFlEX

Biological: XIAFLEX

Interventions

XIAFLEX BIOLOGICAL

One Injection of 0.58 mg of Xiaflex into the affected area of the hand.

Also known as: Collagenase

XIAFLEX

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a diagnosis of Dupuytren's Disease affecting only the metacarpophalangeal joint of the 4th or 5th finger.
• Subject has only one finger affected by the disease.
• Patients will be 35 years of age of older.
• Patients will be able to read, speak, and understand English or have available adequate translation assistance and be able to provide voluntary written consent to participate.

You may not qualify if:

• Female patients who are nursing or pregnant, or plan to become pregnant during the treatment phase.
• Patient has a chronic muscular, neurological or neuromuscular disorder that affects the hands.
• Patient has known allergy to collagenase or any other excipient of Xiaflex.
• Patient has received any collagenase treatments before the first dose of Xiaflex.
• Patient with abnormal coagulation, including patients who have received anticoagulant medications other than low-dose aspirin within 7 days of the injection.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Auxilium Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Hosptial for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

Microbial Collagenase; Collagenases

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Results Point of Contact

• Title: Scott W. Wolfe
• Organization: Hospital for Special Surgery

WolfeS@hss.edu

212-606-1529

Study Officials

• Scott W Wolfe, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2011
• First Posted: October 12, 2011
• Study Start: March 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: February 1, 2012
• Last Updated: April 17, 2017
• Results First Posted: May 15, 2014

Record last verified: 2017-03

Locations

US (1)