Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001045000
Ethics application status
Approved
Date submitted
25/11/2010
Date registered
29/11/2010
Date last updated
21/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
An open-label study to assess the safety, tolerability and multiple-dose phamacokinetics of AA4500 0.58 mg in subjects with Dupuytren's contractures.
Scientific title
An open-label study to assess the safety, tolerability and multiple-dose phamacokinetics of AA4500 0.58 mg in subjects with dupuytren's contractures.
Secondary ID [1] 253177 0
AUX-CC-861
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dupuytren's contracture 258654 0
Condition category
Condition code
Musculoskeletal 258793 258793 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The components of AA4500 are: mixed collagenase AUX I and AUX II, sucrose. The components of the sterile diluent are: 0.03% calcium chloride in 0.9% sodium chloride. Each dose of AA4500 is 0.58mg. The Drug is injected directly into the cord using a 27 gauge (13mm) needle. This is a single dose drug.
Intervention code [1] 257611 0
Treatment: Drugs
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259663 0
The objective of this study is to assess the safety of AA4500 0.58 mg in subjects with multiple Dupuytren's contractures caused by palpable cords.
Timepoint [1] 259663 0
Adverse events collected on Day 1,Day 2, Day 7, Day 30, Day 31, Day 32, Day 37, Day 60, Day 90.
Primary outcome [2] 259733 0
The objective of this study is to assess the tolerability of AA4500 0.58 mg in subjects with multiple Dupuytren's contractures caused by palpable cords.
Timepoint [2] 259733 0
Vital Signs, will be assessed at Screening, Day 1, Day 2, Day 7, Day 30, Day 31, Day 32, Day 37, Day 60, Day 90. Local effects of treatment will be assessed Day 2, Day 7, Day 30, Day 32, Day 37, Day 60, Day 90. Clinical laboratory testing at screening and Day 90.
Primary outcome [3] 259734 0
The objective of this study is to assess multiple-dose pharmacokinetics of AA4500 0.58 mg in subjects with multiple Dupuytren's contractures caused by palpable cords.
Timepoint [3] 259734 0
Pharmacokinetic sampling will be collected at Day 31, Day 32, Day 60 and Day 90.
Secondary outcome [1] 266349 0
Clinical success: A clinical success is defined as a reduction in contracture (flexion deformity) to 5 degrees or less as measured by finger goniometry.
Timepoint [1] 266349 0
30 days after injection
Secondary outcome [2] 266353 0
Pharmacokenetic parameters will be determined for each subject who has quantifiable plasma concentrations.
Timepoint [2] 266353 0
At Day 31, 15 minutes before treatment, 5,10, 20, 30 minutes post treament, then 1,2,4,8,12,24 hours post treament, then 7 days and 30 days post treatment.

Eligibility
Key inclusion criteria
1. Provide written informed consent
2. Be a man or woman greater than of equal to18 years of age and less than or equal to 70 years
3. Have a diagnosis of Dupuytren’s disease and have at least 3 fixed-flexion contractures (2 must be on the same hand) that are = 20 degrees in PIP and/or MP joints in fingers, other than the thumbs, which are caused by palpable cords suitable for treatment
4. Have a positive “table top test” defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top
5. Be naive to AA4500 treatment
6. 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)
7. 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
8. Be able to comply with the study visit schedule as specified in the protocol
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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
2. Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands
3. Has a known systemic allergy to collagenase or any other excipient of AA4500
4. Has received any other collagenase treatments (eg, Santyl (Registered Trademark) ointment) within 30 days before injection of AA4500
5. 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
6. 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
7. Has significant renal or hepatic impairment, which in the opinion of the investigator, could compromise the scientific objectives of the study
8. Is known to be immunocompromised or human immunodeficiency virus (HIV) positive
9. Has a history of illicit drug abuse or alcoholism within the year before injection of AA4500
10. Has a positive alcohol breath test or a positive urine drug screen within 3 days before admission to the study unit
11. Received an investigational drug within 30 days before injection of AA4500
12. Is a pregnant or lactating female
13. 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
14. Has jewelry on the hand to be treated that cannot be removed
15. Requires a local anesthetic before injection of AA4500 or before the finger extension procedure in multiple-dose Period 2

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is an open label study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is an open label study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
open label
Phase
Phase 3
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/12/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258065 0
Commercial sector/Industry
Name [1] 258065 0
Auxilium Phamaceuticals, Inc.
Country [1] 258065 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Auxilium Phamaceuticals, Inc.
Address
40 Valley Stream Parkway
Malvern, PA 19355
Country
United States of America
Secondary sponsor category [1] 257256 0
Commercial sector/Industry
Name [1] 257256 0
Novotech Pty Ltd
Address [1] 257256 0
Level 3, 19 Harris Street
Pyrmont NSW 2009
Country [1] 257256 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260061 0
Queensland Institute of Medical Research HREC
Ethics committee address [1] 260061 0
Ethics committee country [1] 260061 0
Australia
Date submitted for ethics approval [1] 260061 0
15/10/2010
Approval date [1] 260061 0
05/11/2010
Ethics approval number [1] 260061 0
P1315

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31916 0
Address 31916 0
Country 31916 0
Phone 31916 0
Fax 31916 0
Email 31916 0
Contact person for public queries
Name 15163 0
Daphne Craw
Address 15163 0
Novotech Pty Ltd
4 Zig Zag Street
Red Hill 4059
Queensland
Country 15163 0
Australia
Phone 15163 0
61 7 3167 6207
Fax 15163 0
61 7 3167 6298
Email 15163 0
[email protected]
Contact person for scientific queries
Name 6091 0
Nigel Jones
Address 6091 0
Auxilium UK Limited
Orchard Lea
Winkfield Lane
Windsor SL4 4RU
Country 6091 0
United Kingdom
Phone 6091 0
+44 1344 887665
Fax 6091 0
+44 1344 887666
Email 6091 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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