Dupuytren s Disease MedDRA version: 14.1 Level: SOC Classification code 10028395 Term: Musculoskeletal and connective tissue disorders System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: Xiapex
Product Code: NA
Pharmaceutical Form: Injection
Current Sponsor code: Xiapex
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .58-
Trade Name:
Sponsors
AUSL VITERBO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At least 18 years of age and 75 years. ; Patient naive to Xiapex injection. ; Presenting with a Dupuytren s contracture of at least 20 degr caused by a palpable ; cord in at least one finger other than the thumb. ; In good health, based upon the results of a medical history, physical examination, ; and safety laboratory profile. ; Female subjects of child bearing potential must use a highly effective ; contraception method or be surgically sterilized or be a post menopausal female ; (i.e., no menses for at least 1 year). A pregnancy test could be performed prior to ; enrollment in the study. ; 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. ; 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: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: Patients who have known anaphylactic hypersensitivity to the anaesthetics of the ; amide type or any of the components of EMLA cream. ; Patients who are pregnant or breast feeding. ; Patient with glucose-6-phosphate dehydrogenase deficiency or congenital/ ; acquired methaemoglobinaemia. ; Patient with open wounds, infections, atopic dermatitis, skin rashes or cuts at, or ; near, the area where it is needed to apply EMLA Cream. ; Patients with a chronic pain diagnosis. ; Patient with severe kidney or liver disease. ; On an investigational drug within 30 days prior to the first dose of study drug. ; Received a treatment on the selected joint, within 90 days of enrolment in the ; study, for Dupuytren s contracture including needle aponeurotomy or any surgical ; procedure. ; Patients with a known systemic hypersensitivity to collagenase or any of the other ; product excipients. ; On anticoagulant medication or has received anticoagulant medication (except ; aspirin less than 150 mg daily) within 7 days before the first injection. ; 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. ; Has a chronic muscular, neurological, or neuromuscular disorder that affects the ; hands. ; 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 judgement of the investigator, would make the subject ; inappropriate for entry into this study. ; Has jewellery on the hand to be treated that cannot be removed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess pain (due to the needle) immediately after Xiapex injection;;Secondary Objective: To assess pain (due to drug) immediately after Xiapex injection; ; Investigator assessment on degree of difficulty with Xiapex injection; ; To evaluate Patient Global Treatment Satisfaction (at discharge); ; To evaluate global pain at the discharge and after 24h from Xiapex injection ; (before breaking the cords).;Primary end point(s): The primary endpoint is pain due to Xiapex injection (needle insertion) assessed by ; means of VAS.;Timepoint(s) of evaluation of this end point: 6 months form study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Italy
Contacts
Public ContactUOC Chirurgia della Mano
AUSL Viterbo
Outcome results
None listed