Dupuytren’s contracture MedDRA version: 12.1 Level: LLT Classification code 10013873 Term: Dupuytren's contracture operation
Conditions
Interventions
Product Name: Xiapex®
Product Code: PF-05076985
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: USAN: collagenase clostridium histolyticum
CAS Number: 955049-04
Sponsors
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study. Subjects must meet all of the following criteria to enter the study: 1. At least 18 years of age and = 70 years. 2. Presenting with a Dupuytren’s contracture of at least 20 degrees caused by a palpable cord in at least one finger other than the thumb. 3. Positive “table top test” defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top. 4. In good health, based upon the results of a medical history, physical examination, and safety laboratory profile. 5. Female subjects of child bearing potential must use an acceptable method of birth control or be surgically sterilized or be a post menopausal female (ie, no menses for at least 1 year). A pregnancy test will be performed prior to enrollment in the study. 6. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the study: 1. Nursing or pregnant, or plan to become pregnant during the treatment phase. 2. On an investigational drug within 30 days prior to the first dose of study drug. 3. Received a treatment on the selected joint, within 90 days of enrollment in the study, for Dupuytren’s contracture including needle aponeurotomy or any surgical procedure. 4. Patients with a known systemic hypersensitivity to collagenase or any of the other product excipients. 5. On anticoagulant medication or has received anticoagulant medication (except aspirin less than 150 mg daily) within 7 days before the first injection. 6. 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. 7. Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands. 8. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 9. Has jewelry on the hand to be treated that cannot be removed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Specifically, this study will: • Evaluate the impact of Xiapex® on the Dupuytren’s contracture, the Range of Motion (ROM) and the patient and physician reported treatment satisfaction and disease severity and their relationship to ROM. • Assess the recovery to normal activities. • Recovery time (How long overall, Time to use hand, time to return to work or daily activities, amount of work or daily activity time missed or reduced and affects on productivity and daily activities) - assessed via patient diary. • Use of concomitant analgesic medications. • Evaluate total healthcare resource utilization (HCRU) (eg, medical and allied healthcare visits and resources, use of splinting). • Assess the pattern of treatment when multiple joints and or/fingers are treated.;Secondary Objective: Not Applicable;Primary end point(s): Safety: • AEs, vital signs, clinical laboratory parameters and ADAs. Efficacy: • TPED and PED* (Total Passive Extension Deficit: a sum of the Passive Extension Deficits (PED) in the MP, PIP, and DIP joints). • Change in TPED and PED for each joint treated. • ROM. • Patient and physician global assessment of treatment satisfaction and disease severity. Recovery and HCRU: • Type and amount of concomitant pain medications. • Total recovery time, time to use the hand, daily activities, work vs. hobbies. • Healthcare resource utilization questionnaire. | — |
Countries
Denmark, Germany, Hungary, Italy, Spain, Sweden, United Kingdom
Outcome results
None listed