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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00528931
Other study ID # AUX-CC-855
Secondary ID
Status Completed
Phase Phase 1
First received September 11, 2007
Last updated September 7, 2017
Start date September 2007
Est. completion date March 2008

Study information

Verified date September 2017
Source Endo Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date March 2008
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Biological:
collagenase clostridium histolyticum
Single dose of AA4500 0.58 mg into the cord

Locations

Country Name City State
United States Providence Clinical Research Burbank California

Sponsors (1)

Lead Sponsor Collaborator
Endo Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects With AUX I and AUX II Detected in Their Blood After a Single Dose of AA4500 AUX I and AUX II are the constituent protein collagenases of collagenase clostridium histolyticum (AA4500). Plasma concentrations of AUX I and AUX II were assessed through an enzymye-linked-immunoabsorbent assay (ELISA). Before dosing, at predetermined time points through the 24 hours after dosing, Day 7, and Day 30
Secondary Clinical Success Clinical success defined as a reduction in contracture (ie, flexion deformity) to =5° of normal as measured by finger goniometry 30 days after an injection. Last observation carried forward (LOCF) after the injection was used if the status at day 30 could not be determined. 30 days after treatment to the primary joint
Secondary Clinical Improvement Clinical improvement defined as =50% reduction from baseline in contracture within 30 days of the injection. LOCF after the injection was used if the status at day 30 could not be determined. 30 days after treatment to the primary joint
Secondary Percent Change From Baseline Contracture Change from baseline in the degree of fixed-flexion contracture calculated as 100 times (baseline contracture minus last available post-injection contracture measurement) divided by baseline contracture where a positive change indicates a reduction in the degree of contracture. Baseline, 30 days after treatment to the primary joint
Secondary Change From Baseline Range of Motion Range of motion defined as the difference between the finger extension angle and finger flexion angle expressed in degrees Baseline, 30 days after treatment to the primary joint
See also
  Status Clinical Trial Phase
Completed NCT01674634 - Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures Phase 3
Completed NCT01715467 - CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment N/A
Completed NCT01407068 - Administration of Two Injections for Multiple Dupuytren's Contractures Phase 3
Completed NCT00565019 - Effects of Steroid Injection With Percutaneous Needle Aponeurotomy in Dupuytren's Contracture Phase 3
Completed NCT01588353 - Collagenase Option for Reduction of Dupuytren's Contracture in Japan Phase 3
Completed NCT00468949 - Health-Related Quality of Life in Patients With Dupuytren's Disease Phase 1
Completed NCT01444729 - Post Approval Commitment Study N/A
Terminated NCT05877066 - Real-World Data Study to Understand Participant Treatment Outcomes for Dupuytren's Contracture
Completed NCT01229436 - Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex) Phase 3
Completed NCT01265420 - Efficacy and Safety of Xiaflex Injection for Treatment of Dupuytren's Contracture of the Thumb Phase 4
Completed NCT00528606 - AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Dupuytren's Contracture Phase 3
Completed NCT00931567 - Evaluation of the Efficiency of Autologous Platelet Gel (Platelet Rich Fibrin) Obtained From Own Patients' Blood Versus Vaselitulle in Dupuytren's Disease Postoperative Wound Healing Phase 2/Phase 3
Completed NCT00004409 - Phase II Randomized Study of Collagenase in Patients With Residual Type Dupuytren's Disease Phase 2
Completed NCT00014742 - Phase III Randomized Study of Collagenase in Patients With Residual Stage Dupuytren's Disease Phase 3