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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02193828
Registration number
NCT02193828
Ethics application status
Date submitted
19/06/2014
Date registered
18/07/2014
Date last updated
5/10/2017
Titles & IDs
Public title
Phase 2a Dose-Ranging Study to Evaluate Safety and Effectiveness of AA4500 in Treatment of Dupuytren's Disease Nodules
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Scientific title
A Phase 2a, Double-blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Effectiveness of AA4500 in the Treatment of Dupuytren's Disease Nodules
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Secondary ID [1]
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AUX-CC-750
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dupuytren's Disease
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Collagenase clostridium histolyticum
Other interventions - Placebo
Experimental: AA4500 0.25 mg - Collagenase clostridium histolyticum, single 0.25 mg injection
Experimental: AA4500 0.40 mg - Collagenase clostridium histolyticum, single 0.40 mg injection
Experimental: AA4500 0.60 mg - Collagenase clostridium histolyticum, single 0.60 mg injection
Placebo Comparator: Placebo - Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection
Other interventions: Collagenase clostridium histolyticum
Single injection into nodule
Other interventions: Placebo
Single injection into nodule
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Caliper Measurements
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Assessment method [1]
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Percent change from baseline in surface area and volume of the treated nodule was determined from hand-held caliper measurements of the length and width of the nodule. Percent change = 100*(Day 57 area [or volume] - baseline area [or volume])/baseline area [or volume]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening.
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Timepoint [1]
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Baseline, Day 57
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Secondary outcome [1]
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Percent Change From Baseline in Surface Area and Volume of the Treated Nodule at Day 57 Using Ultrasound
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Assessment method [1]
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Percent change from baseline in surface area and volume of the treated nodule was determined from ultrasound measurements of the length, width, and depth of the nodule. Percent change = 100*(Day 57 area [or volume] - baseline area [or volume])/baseline area [or volume]. A negative value represents the improvement from baseline (decreased size) while a positive value represents worsening.
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Timepoint [1]
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Baseline, Day 57
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Secondary outcome [2]
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Change From Baseline in Consistency of the Treated Nodules at Day 57
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Assessment method [2]
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Investigators determined the consistency of the nodule through palpitation using a 5-point scale: 5 = hard (solid), 4 = firm throughout, 3 = moderate firmness, 2 = soft, and 1 = non-palpable. The change scores could range from +4 (greatest worsening in consistency) to -4 (greatest improvement in consistency); a negative change from baseline value reflects improvement from baseline (softening) while a positive value reflects worsening.
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Timepoint [2]
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Baseline, Day 57
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Secondary outcome [3]
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Percent Change From Baseline in Hardness of the Treated Nodule at Day 57
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Assessment method [3]
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A durometer was used to assess nodule hardness on a scale of 0 (soft) to 100 (hard). Percent change = 100*(Day 57 hardness - baseline hardness)/baseline hardness. A negative value represents the improvement from baseline (softening) while a positive value represents worsening.
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Timepoint [3]
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Baseline, Day 57
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Secondary outcome [4]
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Change From Baseline in Nodular Pain of the Treated Nodule at Day 57
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Assessment method [4]
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After the nodule was squeezed using a dynamometer, subjects were asked to rate the amount of pain they felt on an 11-point visual analog scale (VAS) from 0 (no pain or discomfort) to 10 (extreme pain or discomfort). A negative change from baseline value reflects improvement from baseline (less pain) while a positive value reflects worsening.
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Timepoint [4]
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Baseline, Day 57
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Secondary outcome [5]
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Investigator Global Assessment of Improvement With Treatment
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Assessment method [5]
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Investigators were asked to determine the degree of improvement in the subject's treated nodule compared with screening on a 7-point scale: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse.
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Timepoint [5]
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Day 57
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Secondary outcome [6]
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Subject Satisfaction With Treatment
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Assessment method [6]
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Subjects were asked to rate their satisfaction with treatment on a 5-point scale: 1 = very satisfied, 2 = quite satisfied, 3 = neither satisfied nor dissatisfied, 4 = quite dissatisfied, and 5 = very dissatisfied.
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Timepoint [6]
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Day 57
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Secondary outcome [7]
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Composite Responder Analysis
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Assessment method [7]
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A composite responder is a subject who had an improved assessment [values of 1 (very much improved), 2 (much improved), or 3 (minimally improved)] on the investigator global assessment and had a satisfied assessment [values of 1 (very satisfied) or 2 (quite satisfied)] on the subject assessment.
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Timepoint [7]
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Day 57
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Eligibility
Key inclusion criteria
1. Provide a signed and dated informed consent
2. Be a man or woman = 18 years of age
3. Have a diagnosis of Dupuytren's disease AND have at least one palmar nodule on the
selected hand that is:
1. Palpable
2. Measures between 0.5 cm and 2.0 cm in length and between 0.5 cm and 2.0 cm in
width using hand-held calipers n
3. Not directly associated with a Dupuytren's cord
4. Have a negative urine pregnancy test at screening and before injection of study drug
and be using a highly effective (ie, < 1% failure rate) contraception method as judged
by the investigator (eg, abstinence, intrauterine device [IUD], hormonal
[estrogen/progestin] contraceptives, or barrier control) for at least one menstrual
cycle prior to study enrollment and for the duration of the study or be surgically
sterile (if female of childbearing potential); or be a postmenopausal female (no
menses for at least 1 year or hysterectomy)
5. Be able to comply with the study visit schedule as specified in the protocol
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Received steroid injections (eg, tri-amcinolone acetonide) on the selected nodule
within 3 months before administration of study drug
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 collagenase treatments (eg, Santyl® ointment and/or XIAFLEX®/XIAPEX®)
within 30 days before injection of study drug in the hand selected for treatment
5. Is currently receiving or plans to receive anticoagulant medication or has received
anticoagulant medication (except for = 150 mg aspirin daily) within 7 days before
injection of study drug
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. Received an investigational drug within 30 days before injection of study drug
8. Is pregnant or intends on becoming pregnant during the study or is breastfeeding a
child
9. 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
10. Had surgery on the selected hand within 3 months before the screening visit
11. Has jewelry on the hand to be treated that cannot be removed
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2014
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Sample size
Target
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Accrual to date
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Final
76
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Brisbane Hand & Upper Limb Clinic - Brisbane
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Recruitment hospital [2]
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Houston Medical - Kippa Ring
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Recruitment postcode(s) [1]
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4000 - Brisbane
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Recruitment postcode(s) [2]
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4021 - Kippa Ring
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Indiana
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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North Carolina
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Country [6]
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United States of America
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State/province [6]
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Oklahoma
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Country [7]
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United States of America
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State/province [7]
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Pennsylvania
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Endo Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The objectives of this study are to assess the safety and effectiveness of AA4500 in treating
palmar Dupuytren's disease nodules.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02193828
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Veronica Urdaneta, MD MPH
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Address
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Endo Pharmaceuticals
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02193828
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