E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Dupuytrens contracture |
Dupuytrens kontraktur |
|
E.1.1.1 | Medical condition in easily understood language |
Connective tissue building in the hand resulting in contracture of fingers. |
kuskefingre. Bindevævsdannelse i hulhånden medførende strækmangel i fingre. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065799 |
E.1.2 | Term | Fibrosis deep connective tissue |
E.1.2 | System Organ Class | 100000004859 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
to evaluate difference in recurrence rate of dupuytrens contracture following needlefasciotomi or collagenase enzyme injection. |
at vurdere forskellen i tilbagefaldsfrekvens ved behandling af dupuytrens kontraktur med nålefasciotomi eller collagenaseindsprøjtning. |
|
E.2.2 | Secondary objectives of the trial |
to evaluate the primary result after treatment of dupuytrens contracture with needle fascitomi or collagenase enzyme injection.
to measure patientevaluated hand function (quick dash) during treatment of dupuytrens contracture with needlefasciotomo or collagenase enzyme injection. |
at evaluere det primære behandlingsresultat ved behandling af dupuytrens kontraktur med nålefasciotomi eller collagenasebehandling.
at måle patientevalueret håndfunktion (quick dash) efter behandling af dupuytrens kontraktur med nålefasciotomi eller collagenasebehandling. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Dupuytrens disease with one cord in the hand pointing at 2nd, 3rd, 4th or 5th finger.
2) Lag of extension im metacarpophalangeal joint of at least 30 degrees.
3) age > 18 years
4) women and men |
1) Dupuytrens sygdom med enkelt streng i håndfladen gående imod 2.,3.,4. eller 5 finger.
2) strækmangel på min 30 grader i grundled.
3) alder over 18 år
4) kvinder og mænd |
|
E.4 | Principal exclusion criteria |
1) Former treatment of Dupuytrens disease in the same hand.
2) Other signs of dupuytrens disease than a single cord.
3) lag of extension in proximal- and distal interphalangeal joint in the affected finger.
4) Other dibiliating disease in the affected hand.
5) Allergi or intollerance of collagenase enzyme
6) pregnant women
7) patient that cannot attend follow up
8) anticoagulant medicin other than ASA 150 mg daily
9) treatment with tetracyclin or ciprofloxacin within 2 weeks. |
1) Tidligere behandlet for Dupuytrens sygdom i pågældende hånd.
2) Andre Dupuytrenforandringer end den isolerede streng.
3)Strækmangel i afficerede fingers mellem- eller yderled.
4) Anden væsentlig sygdom i hden afficerede hånd.
5) Allergi eller intolerans over for collagenase.
6) gravide
7) patienter som ikke kan forventes at møde til klinisk opfølgning.
8) antikoagulans andet end ASA 150 mg dagligt.
9) behandling med tetracyklin eller ciprofloxacin sidste 2 uger |
|
E.5 End points |
E.5.1 | Primary end point(s) |
extensionlag in affected finger |
strækmangel i afficeret finger. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
after 1 y , 2 y , 3 y and 5 y |
efter 1 ,2 ,3 og 5 år. |
|
E.5.2 | Secondary end point(s) |
Extensionlag after primary treatment.
quick-dash score before and after treatment (patientevaluated hand function) |
strækmangel efter primær behandling.
quick- dash score før og efter behandling. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) after initial treatment.
2) before treatment and after 1y , 2y , 3y and 5 y |
1) efter afsluttet behandling
2) før behandling og efter 1, 2, 3 og 5 år. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
nålefasciotomi , minimal invasiv kirurgi |
needle fasciotomi , minimal invasive surgery |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
when last patient (no 90) has been evaluated 5 years after treatment. |
når sidste patient (nr 90) har været til klinisk kontrol 5 år efter behandling. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |