|- candidate number||11173|
|- NTR Number||NTR3300|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-feb-2012|
|- Secondary IDs||39032 / 2012-000516-28 / 2012/148; ABR / EudraCT / METC UMCG|
|- Public Title||The efficacy of CCH in the thumb and first webspace in Dupuytren's Disease.|
|- Scientific Title||A prospective clinical study on the efficacy of collagenase clostridium histolyticum (Xiapex) injections in the thumb and first web space contractures in Dupuytren’s Disease.|
|- hypothesis||We hypothesize that treatment with collagenase clostridium histolyticum (Xiapex) injections will also be effective and show significant improvement in outcomes for patients with DD with contractures of the thumb and first webspace. |
|- Healt Condition(s) or Problem(s) studied||Thumb , Dupuytren's Disease, First webspace, Collagenase injections|
|- Inclusion criteria||1. At least 18 years of age and ≤ 75 years;|
2. Presenting with a Dupuytren’s contracture at MCPJ of thumb of at least 20° caused by a palpable cord, or any adduction contracture of the thumb with palpable cords in first web space;
3. In good health, based upon the results of a medical history and physical examination;
4. Female patients of child bearing potential must use an acceptable method of birth control or be surgically sterilized or be a post menopausal female (i.e. no menses for at least 1 year). A pregnancy test will be performed prior to enrolment in the study in fertile women;
5. Patients who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
|- Exclusion criteria||1. Nursing or pregnant, or planning to become pregnant during the treatment phase;|
2. On an investigational drug within 30 days prior to the first dose of CCH;
3. 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;
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 150mg 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 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;
9. Has jewellery on the hand to be treated that cannot be removed.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-apr-2012|
|- planned closingdate||1-apr-2014|
|- Target number of participants||15|
|- Interventions||For each patient the study will have 2 phases. The first phase will be an open label treatment phase (up to 3 months in duration) while the second phase will be a 6 month follow up phase.|
A maximum of 3 treatment cycles will be offered to each subject where a treatment cycle consists of an injection with CCH (0,58mg) followed by a thumb extension/abduction procedure 24 hrs later and a 30 day follow up period. A maximum of 3 injections will be allowed into the same cord.
In case patients have an adduction contracture and a flexion contracture, they can choose which cord to treat. Measurements of contractures will be taken with goniometer and polluxohgraphy (2) before injection and at follow- up visits.
Follow-up visits will take place at 1 day after injection, 7 days, 30 days, 90 days and 6 months after the last treatment cycle, whereby objective as well as subjective measures will be used and patient/doctor satisfaction will be determined with the help of questionnaires.
|- Primary outcome||Reduction in extension deficit to 0-5 degrees 30 days after last injection.|
|- Secondary outcome||1. Goniometry and pollexography will be used to measure baseline and 1, 7, 30 and 90 days and 6 months after last injection for mean change in range of motion from baseline - degrees;|
2. Change in “Patient and physician global assessment of treatment satisfaction” from baseline and 7, 30 and 90 days and 6 months after injection, whereby investigator and patient will complete a brief set of questions;
3. Change in outcome of PRWHE DLV (Patient rated wrist/hand evaluation Dutch language version (37)) from baseline and 7, 30 and 90 days and 6 months after injection whereby the patient will fill in the questionnaire;
4. Photographs will be taken of the diseased hand, during screening and at 30 and 90 days and 6 months.
|- Timepoints||1. Day 1: Injection;|
2. Day 2: Stretching;
3. Day 7, 30, 90 and 6 months post injection: Follow-up.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| M. Dreise|
|- CONTACT for SCIENTIFIC QUERIES|| P.M.N. Werker|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Dupuytren's disease can be very disabling especially when the thumb and first webspace are affected. The results of collagenase injection studies showed significantly improved outcomes in the treatment of Dupuytren's Disease in the MCP and PIP joints in the long fingers.
The efficacy of the treatment has not yet been studied for Dupuytren's Disease in the thumb, while at the same time treatment of the thumb with the existing surgical options is more difficult than of the fingers. We expect that the injections in cords affecting the thumb and first webspace will greatly improve abduction and reduce extension deficits, thereby increasing the ability of the patient in daily living activities.|
|- Main changes (audit trail)|
|- RECORD||21-feb-2012 - 23-jul-2012|