|- candidate number||14467|
|- NTR Number||NTR3883|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-mrt-2013|
|- Secondary IDs||NL40807 / 2009-015090-12; ABR / EudraCT|
|- Public Title||Standard Treatment Or topical doxepin against Pruritus in burn patients.|
|- Scientific Title||Standard Treatment Or topical doxepin against Pruritus in burn patients.|
|- ACRONYM||STOP trial|
|- hypothesis||Doxepin cream is more effective in reducing postburn pruritus compared with standard treatment.|
|- Healt Condition(s) or Problem(s) studied||Burns, Pruritus|
|- Inclusion criteria||In order to be eligible to participate in this study, a subject must meet all of the following criteria:|
1. Patients with healed burns and itch;
2. Itch intensity as assessed by VAS score greater than or equal to 3;
3. Patients treated in one of the three Dutch burn centres;
4. Patients aged 18 years or older.
|- Exclusion criteria||An eligible subject who meets any of the following criteria will be excluded from participation in this study:|
1. Inability to give informed consent by patient or legal representatives;
2. Inability to understand and fill in VAS scores and quality of life/pruritus assessment questionnaires, as judged by the treating physician;
3. Known pregnancy or breast-feeding;
4. (Active) cutaneous or systemic disease causing itch;
5. Any disease or condition which, according to the physician's judgement, is associated with adverse effects using doxepin.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||27-dec-2013|
|- planned closingdate||1-jun-2014|
|- Target number of participants||108|
|- Interventions||Patients will be randomised between:|
1. Doxepin hydrochloride 5% cream, placebo tablets;
2. Placebo cream, clemastine 1 mg tablets.
Treatment will be given as long as the complaints persist.
|- Primary outcome||To evaluate whether doxepin hydrochloride 5% cream is more effective in reducing pruritus in patients with burns than standard treatment.|
|- Secondary outcome||To evaluate whether patients treated with doxepin hydrochloride 5% cream compared to standard treatment:|
1. Have a better quality of life;
2. Have less erythematous scars.
|- Timepoints||During the first two weeks patients will keep a diary. Furthermore patients will visit the out-patient clinic at randomisation (0 weeks), 2 weeks, 6 weeks and 12 weeks for additional assessments.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD. H.C. Kuipers|
|- CONTACT for SCIENTIFIC QUERIES||Prof. R.S. Breederveld|
|- Sponsor/Initiator ||Association of Dutch Burn Centres|
(Source(s) of Monetary or Material Support)
|Dutch Burns Foundation (Nederlandse Brandwonden Stichting)|
|- Publications||1. Demling R, DeSanti L, Nelson R. Pruritus and burn wound. Wounds 2002;14:2A-7A. |
2. Demling R, DeSanti L. Topical doxepin significantly decreases itching and erythema in the chronically pruritic burn scar. Wounds 2003;15(6):195-200.
|- Brief summary||Pruritus is a common problem in patients with healed burn wounds and causes severe morbidity. Standard treatment of pruritus consist of moisturizers, pressure garments and oral antihistamines. Doxepin hydrochloride 5% cream has potent H1 and H2 histamine receptor blocking properties and was found to have anti-pruritic properties in previous studies in patients with burns.|
Our goal is to perform a randomised, double-blind study to evaluate the efficacy of doxepin hydrochloride 5% cream.
|- Main changes (audit trail)|
|- RECORD||6-mrt-2013 - 27-mrt-2014|