Phase 2a Dose-Ranging Study to Evaluate Safety and Effectiveness of AA4500 in Treatment of Dupuytren's Disease Nodules
NCT ID: NCT02193828
Last Updated: 2017-10-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2014-07-31
2014-12-31
Brief Summary
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Detailed Description
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After all pre-injection procedures are completed on day 1, eligible men and women will be randomized in a 1:1:1 ratio to dose group and then in a 4:1 ratio to treatment group. Study drug will be administered into a palmar nodule located on the selected hand.
AA4500 (collagenase clostridium histolyticum) 3 doses (low, medium, and high) after reconstitution with sterile diluent (0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride). Each dose of study drug will be injected into the nodule. The injection will be administered in 3 different volumes according to randomization.
Placebo after reconstitution with sterile diluent (0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride). Each dose of study drug will be injected into the nodule. The injection will be administered in 3 different volumes according to randomization.
Follow up visits for the evaluation of safety and efficacy will be required for all subjects on days 8, 29, and 57.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AA4500 0.25 mg
Collagenase clostridium histolyticum, single 0.25 mg injection
Collagenase clostridium histolyticum
Single injection into nodule
AA4500 0.40 mg
Collagenase clostridium histolyticum, single 0.40 mg injection
Collagenase clostridium histolyticum
Single injection into nodule
AA4500 0.60 mg
Collagenase clostridium histolyticum, single 0.60 mg injection
Collagenase clostridium histolyticum
Single injection into nodule
Placebo
Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection
Placebo
Single injection into nodule
Interventions
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Collagenase clostridium histolyticum
Single injection into nodule
Placebo
Single injection into nodule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Veronica Urdaneta, MD MPH
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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Tucson Orthopaedic Institute
Tucson, Arizona, United States
CORE Orthopaedic Medical Center
Encinitas, California, United States
Marin Endocrine Care & Research, Inc.
Greenbrae, California, United States
Brigid Freyne, MD, Inc.
Murrieta, California, United States
Indiana Hand to Shoulder Center
Indianapolis, Indiana, United States
State University of New York
Stony Brook, New York, United States
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, United States
Orthopedic and Reconstructive Center
Oklahoma City, Oklahoma, United States
Blair Orthopedic Associates, Inc.
Altoona, Pennsylvania, United States
Brisbane Hand & Upper Limb Clinic
Brisbane, Queensland, Australia
Houston Medical
Kippa-Ring, Queensland, Australia
Countries
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References
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Costas B, Coleman S, Kaufman G, James R, Cohen B, Gaston RG. Efficacy and safety of collagenase clostridium histolyticum for Dupuytren disease nodules: a randomized controlled trial. BMC Musculoskelet Disord. 2017 Aug 30;18(1):374. doi: 10.1186/s12891-017-1713-z.
Other Identifiers
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AUX-CC-750
Identifier Type: -
Identifier Source: org_study_id