Dupuytren contracture MedDRA version: 20.0 Level: PT Classification code 10013872 Term: Dupuytren's contracture System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Sponsors
Fidia Farmaceutici Spa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and Age: men/women, =18 year old inclusive 3. Dupuytren contracture: diagnosis of Dupuytren contracture with a fixed flexion deformity =20° and =100°, if in a MP joint, or =20° and =80°, if in a PIP joint, of at least one finger, other than the thumb, caused by a palpable cord that, according to the investigator’s judgement, could benefit from treatment with collagenase 4. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study 5. Contraception and fertility (women only): women of child-bearing potential must be using at least one of the following reliable methods of contraception: a. Hormonal oral, implantable, transdermal or injectable contraceptives for at least 2 months before the screening visit b. A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit c. A male sexual partner who agrees to use a male condom with spermicide d. A sterile sexual partner e. Sexual abstinence Women of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted. For all women of child-bearing potential, pregnancy test result must be negative at screening and Day 1 at pre-dose. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: 1. Previous Dupuytren contracture treatments: previous treatments of Dupuytren contracture including needle aponeurotomy (percutaneous needle fasciotomy) or injection of verapamil or interferon on the selected primary joint 2. Previous Dupuytren contracture surgical treatments: previous fasciectomy or surgical fasciotomy in the primary joint hand 3. Previous treatment with Clostridium histolyticum or Vibrio alginolyticus collagenase 4. Hand disorders: chronic muscular, neurological or neuromuscular disorders affecting hands 5. Bleeding and anticoagulants: history of bleeding or anticoagulant therapy within 7 days of the screening with the exception of daily intake of aspirin 6. Allergy: ascertained or presumptive hypersensitivity to collagenase and/or formulation diluent and/or excipients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study 7. Diseases: significant history of cardiovascular diseases including known recent history of stroke or skin diseases, or endocrine or neurological diseases that affected the hands or of any other medical condition which in the investigator’s opinion may interfere with the aim of the study 8. Medications: intake of tetracyclines, anthracycline derivatives, quinolones or fluoroquinolones within 14 days before the screening 9. Investigative drug studies: participation in the evaluation of any investigational product for 30 days before this study 10. Pregnancy (women of child-bearing potential only): positive or missing pregnancy test at screening or Day 1, pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the efficacy of up to 3 injections of V. alginolyticus collagenase into the affected cord in the primary joint (MP or PIP) in terms of clinical success in the treatment of the Dupuytren contracture as compared to matching placebo.;Secondary Objective: 1. to evaluate the efficacy of up to 3 injections of V. alginolyticus collagenase into the affected cord in the primary joint in terms of clinical improvement of the Dupuytren contracture as compared to matching placebo 2. to evaluate the mean number of injections of V. alginolyticus collagenase into the affected cord in the primary joint necessary to achieve clinical success as compared to matching placebo 3. to evaluate the median time (in days) to achieve and maintain clinical success after the last injection of V.alginolyticus collagenase into the affected cord in the primary joint as compared to matching placebo. ;Primary end point(s): Proportion of patients who achieve clinical success defined as a reduction in contracture from baseline to =5° In the evaluation of each endpoint, MP and PIP joints will be evaluated cumulatively and separated.;Timepoint(s) of evaluation of this end point: in 30±3 days after the last injection of V. alginolyticus collagenase or matching placebo into the cord in the affected primary joint as measured by passive angle of finger extension | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of patients who achieve a clinical improvement defined as a reduction from baseline in contracture by =50%;Timepoint(s) of evaluation of this end point: in 30±3 days after the last injection of V. alginolyticus collagenase or matching placebo into the cord in the affected primary joint as measured by passive angle of finger extension | — |
Countries
Austria, Germany, Italy
Contacts
Public ContactClinical Research
Cross Research SA
Outcome results
None listed