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This was a Phase 3, double-blind, randomized, placebo-controlled study conducted in the United States. Subjects with a diagnosis of Dupuytren's contracture in a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one finger, other than the thumb, that was at least 20° as measured by finger goniometry and was suitable for injection were randomized 2:1 to receive AA4500 0.58 mg or placebo.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AA4500 0.58 mg | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| collagenase clostridium histolyticum | Biological | Subjects could have received up to three injections of AA4500 into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection | The Primary Outcome Measure for patients treated with AA4500 is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection. The Primary Outcome Measure for placebo treated patients is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection. | Within 30 days after the last injection |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Improvement After the Last Injection | Clinical Improvement is defined as >= 50% reduction from baseline in degree of contracture within 30 days of the injection. | Baseline; within 30 days after the last injection |
| Percent Reduction From Baseline Contracture After the Last Injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Veronica Urdaneta, MD | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 100 UCLA Medical Plaza, Suite 305 | Los Angeles | California | 90095 | United States | ||
| Hand Surgery Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21967070 | Derived | Witthaut J, Bushmakin AG, Gerber RA, Cappelleri JC, Le Graverand-Gastineau MP. Determining clinically important changes in range of motion in patients with Dupuytren's Contracture: secondary analysis of the randomized, double-blind, placebo-controlled CORD I study. Clin Drug Investig. 2011 Nov 1;31(11):791-8. doi: 10.1007/BF03256918. | |
| 19726771 |
| Label | URL |
|---|---|
| XIAFLEX Prescribing Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | AA4500 0.58 mg | collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints |
| FG001 | Placebo | Placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Biological | Subjects could have received up to three injections of placebo into the cord of the affected hand. Each injection was separated by at least 30 days. Individual cords may have received up to a maximum of three injections. |
|
Percent change in degree of contracture measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture. |
| Baseline; within 30 days after the last injection |
| Change From Baseline Range of Motion After the Last Injection | Change in degree of motion measured as last available post-injection range of motion - baseline range of motion. | Baselin; within 30 days after the last injection |
| Time to First Achieve Success After the Last Injection | Last evaluation visit on which clinical success is achieved through the Day 30 evaluation |
| Clinical Success (Reduction in Contracture to 5° or Less) After the First Injection | Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection. | Within 30 days after first injection |
| Clinical Improvement After the First Injection | Clinical Improvement is defined as >= 50% reduction from contracture within 30 days of the first injectionor greater of baseline contracture within 30 days of the injection. | Baseline; within 30 days after the first injection |
| Percent Reduction From Baseline Contracture After the First Injection | Percent change in degree of contracture measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture. | Baseline, within 30 days after the first injection |
| Change From Baseline Range of Motion After the First Injection | Change in degree of motion measured as last available post-injection range of motion - baseline range of motion. | Baseline; within 30 days after the first injection |
| Palo Alto |
| California |
| 94304 |
| United States |
| Hand Surgery Associates, PC | Denver | Colorado | 80210 | United States |
| The Hand and Upper Extremity Center of Georgia, P.C. | Atlanta | Georgia | 30342 | United States |
| Rockford Orthopedic Associates, Ltd. | Rockford | Illinois | 61107 | United States |
| The Indiana Hand Center | Indianapolis | Indiana | 46260 | United States |
| Brigham and Women's Hospital, Department of Orthopedic Surgery | Boston | Massachusetts | 02115 | United States |
| Newton-Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
| TRIA Orthopaedic Center | Minneapolis | Minnesota | 55431 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| SUNY Stony Brook - Department of Orthopedics | Stony Brook | New York | 11794 | United States |
| Health Research Institute | Oklahoma City | Oklahoma | 73109 | United States |
| Hand Microsurgery & Reconstructive Orthopaedics | Erie | Pennsylvania | 16550 | United States |
| University Orthopedics Center | State College | Pennsylvania | 16801 | United States |
| Department of Orthopaedics, Brown University, Rhode Island Hospital | Providence | Rhode Island | 02905 | United States |
| Hurst LC, Badalamente MA, Hentz VR, Hotchkiss RN, Kaplan FT, Meals RA, Smith TM, Rodzvilla J; CORD I Study Group. Injectable collagenase clostridium histolyticum for Dupuytren's contracture. N Engl J Med. 2009 Sep 3;361(10):968-79. doi: 10.1056/NEJMoa0810866. |
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| ID | Title | Description |
|---|---|---|
| BG000 | AA4500 0.58 mg | collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints |
| BG001 | Placebo | placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Success (Reduction in Contracture to 5° or Less) of the Primary Joint After the Last Injection | The Primary Outcome Measure for patients treated with AA4500 is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection. The Primary Outcome Measure for placebo treated patients is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5° of normal within 30 days of injection. | Modified-Intent-to-Treat population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees) | Posted | Number | Percentage of Joints | Within 30 days after the last injection |
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| Secondary | Clinical Improvement After the Last Injection | Clinical Improvement is defined as >= 50% reduction from baseline in degree of contracture within 30 days of the injection. | Modified ITT population( Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees) | Posted | Number | Percentage of Joints | Baseline; within 30 days after the last injection |
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| Secondary | Percent Reduction From Baseline Contracture After the Last Injection | Percent change in degree of contracture measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture. | Modified ITT population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees) | Posted | Mean | Standard Deviation | Percent reduction from baseline | Baseline; within 30 days after the last injection |
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| Secondary | Change From Baseline Range of Motion After the Last Injection | Change in degree of motion measured as last available post-injection range of motion - baseline range of motion. | Modified ITT Population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees) | Posted | Mean | Standard Deviation | degrees | Baselin; within 30 days after the last injection |
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| Secondary | Time to First Achieve Success After the Last Injection | Modified ITT population | Posted | Number | percentage of joints | Last evaluation visit on which clinical success is achieved through the Day 30 evaluation |
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| Secondary | Clinical Success (Reduction in Contracture to 5° or Less) After the First Injection | Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection. | Modified ITT population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees) | Posted | Number | Percentage of Joints | Within 30 days after first injection |
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| Secondary | Clinical Improvement After the First Injection | Clinical Improvement is defined as >= 50% reduction from contracture within 30 days of the first injectionor greater of baseline contracture within 30 days of the injection. | Modified ITT population (Intent-to-treat subjects were excluded from this population if they did not have fixed-flexion measurements after the first injection or had both screening and Treatment 1, Day 0 fixed-flexion measurements between 0 and 5 degrees) | Posted | Number | Percentage of Joints | Baseline; within 30 days after the first injection |
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| Secondary | Percent Reduction From Baseline Contracture After the First Injection | Percent change in degree of contracture measured as 100* (baseline contracture - last available post-injection contracture)/baseline contracture. | Modified ITT population | Posted | Mean | Standard Deviation | Percent reduction from baseline | Baseline, within 30 days after the first injection |
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| Secondary | Change From Baseline Range of Motion After the First Injection | Change in degree of motion measured as last available post-injection range of motion - baseline range of motion. | Modified ITT population (Change in degree of motion measured as last available post-injection range of motion - baseline range of motion) | Posted | Mean | Standard Deviation | degrees | Baseline; within 30 days after the first injection |
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Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study.
This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide & XIAFLEX Prescribing Information (see links above).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AA4500 0.58 mg | collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints | 8 | 204 | 196 | 204 | ||
| EG001 | Placebo | placebo injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints | 1 | 104 | 25 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute cholecystitis | Hepatobiliary disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Complex regional pain syndrome | Nervous system disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Ligament disorder | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Panic attack | Psychiatric disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Pelvi-ureteric obstruction | Renal and urinary disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Spinal fusion surgery | Surgical and medical procedures | MedDRA (8.0) | Non-systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blister | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
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| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Injection site swelling | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Lymph node pain | Blood and lymphatic system disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
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| Tenderness | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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Auxilium Pharmaceuticals, Inc. agreements may vary with individual investigators but will not prohibit any investigator from publishing. Auxilium supports the publication of results from all centers of a multicenter trial but requests that reports based on single site data not preceed the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Coordinator | Endo Pharmaceuticals, Inc. | clinicalsite.inquiries@endo.com |
| ID | Term |
|---|---|
| D004387 | Dupuytren Contracture |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003286 | Contracture |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D003012 | Microbial Collagenase |
| ID | Term |
|---|---|
| D017364 | Collagenases |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
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| >=65 years |
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| Male |
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| Hispanic |
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