A Pharmacokinetic Study of AA4500 (XIAFLEX™, Proposed Name) in Subjects With Dupuytren's Contracture

NCT ID: NCT00528931

Last Updated: 2017-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-03-31

Brief Summary

A Phase 1, open-label, single-dose pharmacokinetic study in subjects with Dupuytren's contracture conducted at one site in the United States. All subjects received a single dose of AA4500 0.58 mg, which was injected directly into the cord affecting either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint. Pharmacokinetic blood samples were collected before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30. Efficacy and safety assessments were performed up to 30 days after the AA4500 0.58 injection.

This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 [NCT00528606]and AUX-CC-859 [NCT00533273]) and 7 non-pivotal studies were evaluated.

Conditions

Dupuytren's Contracture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

AA4500 0.58 mg

Group Type: EXPERIMENTAL

collagenase clostridium histolyticum

Intervention Type: BIOLOGICAL

Single dose of AA4500 0.58 mg into the cord

Interventions

collagenase clostridium histolyticum

Single dose of AA4500 0.58 mg into the cord

Intervention Type: BIOLOGICAL

Other Intervention Names

XIAFLEX®; AA4500

Eligibility Criteria

Inclusion Criteria

• Subjects with a diagnosis of Dupuytren's contracture, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100° for MP (80° for PIP) joints, caused by a palpable cord.
• Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
• Were naive to AA4500 treatment.
• Were judged to be in good health.

Exclusion Criteria

• Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
• Had received treatment for Dupuytren's contracture within 90 days of the AA4500 injection to the MP or PIP selected, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon on the selected primary joint within 90 days before the first dose of study drug.
• Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Endo Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veronica Urdaneta, MD

Role: STUDY_DIRECTOR

Endo Pharmaceuticals

Locations

Providence Clinical Research

Burbank, California, United States

Countries

United States

Related Links

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125338lbl.pdf

XIAFLEX Prescribing Information

Other Identifiers

AUX-CC-855

Identifier Type: -

Identifier Source: org_study_id