Administration of Two Injections for Multiple Dupuytren's Contractures

NCT01407068 | Completed Phase 3 Results

• 1 other identifier: AUX-CC-864
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 8

Brief Summary

The objectives of this study are to assess the safety and efficacy of concurrent administration of two injections of AA4500 into the same hand of subjects with multiple Dupuytren's contractures caused by palpable cords.

Conditions

Dupuytren's Contracture

Outcome Measures

Primary Outcomes (2)

• Percent Change From Baseline in Total Fixed Flexion

  Total fixed flexion is defined as the sum of the fixed flexion contractures of the two joints receiving treatment. Change in fixed-flexion contracture is measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees

  30 days after last injection

• Change in Total Range of Motion

  The total range of motion is the sum of the range of motion measurements of the two treated joints. Range of motion is defined as difference between full flexion angle and full extension angle expressed in degrees.

  30 days after last injection

Secondary Outcomes (3)

• Subject Satisfaction With Treatment

  60 days after last injection

• Investigator Assessment of Improvement With Treatment

  60 days after last injection

• Clinical Success by Joint Type

  30 days after injection

Study Arms (1)

AA4500

EXPERIMENTAL

AA4500 collagenase clostridium histolyticum

Biological: AA4500 collagenase clostridium histolyticum

Interventions

AA4500 collagenase clostridium histolyticum BIOLOGICAL

2 concurrent injections (0.58 mg) into 2 cords on the same hand

Also known as: Xiaflex, Xiapex

AA4500

Eligibility Criteria

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

You may qualify if:

• Provide written informed consent
• Be a man or woman ≥ 18 years of age
• Have a diagnosis of Dupuytren's disease and have at least 2 fixed-flexion contractures on the same hand that are ≥ 20º in PIP and/or MP joints in fingers, other than the thumbs, which are caused by palpable cords suitable for treatment
• Have a positive "table top test" defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top
• Either be using an accepted method of birth control (ie, surgical sterilization; intra uterine contraceptive device; oral contraceptive; diaphragm or condom in combination with contraceptive cream, or jelly or foam) and have negative pregnancy testing before administration of AA4500, if a female of childbearing potential, or be a postmenopausal female (no menses for at least 1 year or hysterectomy)
• Not have any clinically significant medical history or condition(s) that would, in the opinion of the investigator, substantially increase the risk associated with the subject's participation in the protocol or compromise the scientific objectives of the study
• Be able to comply with the study visit schedule as specified in the protocol

You may not qualify if:

• Received surgery (fasciectomy or surgical fasciotomy) and/or needle aponeurotomy/fasciotomy on the selected joints to be treated within 90 days before the first injection of AA4500
• Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands
• Has a known systemic allergy to collagenase or any other excipient of AA4500
• Has received any collagenase treatments (eg, Santyl® ointment and/or XIAFLEX/XIAPEX) within 30 days before injection of AA4500
• Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for ≤ 150 mg aspirin daily and over-the-counter nonsteroidal anti-inflammatory drugs \[NSAIDs\]) within 7 days before injection of AA4500)
• Has a known recent history of stroke, bleeding, or other medical condition, which in the investigator's opinion would make the subject unsuitable for enrollment in the study
• Is known to be immunocompromised or human immunodeficiency virus (HIV) positive
• Has a history of illicit drug abuse or alcoholism within the year before injection of AA4500
• Received an investigational drug within 30 days before injection of AA4500
• Is a pregnant or lactating female
• Has any clinically significant medical history or condition(s), including conditions that affect the hands, that would, in the opinion of the investigator, substantially increase the risk associated with the subject's participation in the protocol or compromise the scientific objectives of the study
• Has jewelry on the hand to be treated that cannot be removed

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (8)

Tucson Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

The Indiana Hand Center

Indianapolis, Indiana, 46260, United States

Location

Department of Orthopaedics SUNY-Stony Brook

Stony Brook, New York, 11794, United States

Location

Health Research Institute

Oklahoma City, Oklahoma, 73109, United States

Location

AusTrials

Auchenflower, QLD 4067, Australia

Location

AusTrials

Auchenflower, QLD4066, Australia

Location

AusTrials

Kippa-Ring, QLD 4020, Australia

Location

Emeritus Research

Malvern, VIC 3144, Australia

Location

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

Microbial Collagenase; xiapex

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)

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

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Endo Pharmaceuticals, Inc.

clinicalsite.inquiries@endo.com

Study Officials

• Veronica Urdaneta, MD, MPPH

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: August 1, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: October 5, 2017
• Results First Posted: February 20, 2015

Record last verified: 2017-09

Locations

AU (4); US (4)