The purpuse of this study is , in subjets affected by Dupuytren's and treated with local injection of Xiapex into fibrotic Dupuytren's cords , to promote patient confort and satisfaction by relieve pain due to Xiapex injection by the use of EMLA cream

• Conditions: Dupuytren s Disease; MedDRA version: 14.1Level: SOCClassification code 10028395Term: Musculoskeletal and connective tissue disordersSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-005357-23-IT
• Lead Sponsor: AUSL VITERBO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-11
• Last Update Posted: 5 August 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified