The primary objective of this study is to evaluate the efficacy and safety of naltrexone in the treatment of itch in patients with burn wounds.
ID
Bron
Verkorte titel
Aandoening
Pruritus, Burns, Naltrexone, Treatment
Jeuk, Brandwonden, Naltrexon, Behandeling
Ondersteuning
Dept. of Surgery
Martini Hospital
P.O. box 30033
9700 RM Groningen
The Netherlands
T. Visser, Pharm.D.
Dept. of Pharmacy
Martini Hospital
P.O. box 30033
9700 RM Groningen
The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Mean itch intensity score at end point, defined as the mean of the last 7 diary entries while the patient is receiving study medication.
2. The percentage change in itch intensity score from baseline is calculated as:
1- (mean itch intensity score end point / mean itch intensity score baseline)) x 100%
Achtergrond van het onderzoek
Most patients with burn wounds develop itch which can last for several months to years. The current standard approach with vaseline, pressure clothing and occasionally anti-histamine is often ineffective and currently no other medicine have proven to be effective. As possible treatment of itch, naltrexone is investigated. Via opioid receptors in the central and peripheral nervous system endogen opioids modify the perception of itch. The opioid antagonist naltrexone of the ì-, ê-, en ä receptors suppresses the opioid pathway and could therefore be effective in the treatment of itch in patients with burn wounds.
Doel van het onderzoek
The primary objective of this study is to evaluate the efficacy and safety of naltrexone in the treatment of itch in patients with burn wounds.
Onderzoeksproduct en/of interventie
Patients will take either naltrexone or placebo for two weeks and are randomised to start with one or the other. Before the 2 treatment periods a baseline measurement of 7 days will be done. In between the two treatment periods there will be a wash-out period of 3 days. The naltrexone dose will be 50mg once daily. On the first day patients will receive two times 25mg of naltrexone with at least one hour in between. The procedure on the first day will be mimicked where the placebo is concerned.
Publiek
P.O. box 30033
A. Wieringa
Groningen 9700 RM
The Netherlands
+31 (0)50 5245771
andre.wieringa@mzh.nl
Wetenschappelijk
P.O. box 30033
A. Wieringa
Groningen 9700 RM
The Netherlands
+31 (0)50 5245771
andre.wieringa@mzh.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Eligible for inclusion are patients:
1. with (almost) healed burns who have been admitted to the burn centre;
2. are 18 years of age or older with itch 4-6 weeks postburn.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients will be excluded when meeting one of the following exclusion criteria:
1. TBSA of more than 20%;
2. Liver insufficiency (in this study that means more than 2 times the normal range of the liverenzymes: ASAT> 80 U/L and/or ALAT >80 U/L and/or AF > 250U/L and/or gamma GT >100U/L);
3. Acute hepatitis;
4. History of drug/alcohol abuse;
5. Known sensitivity for any of the following substances: naltrexonehydrochloride, lactose monohydrate, crospovidone, powder cellulose, microcrystalline cellulose, colloid silicon dioxide, magnesium stearate, hypromellose, macrogole 4000, Titanium dioxide (E171), Black iron oxide (E172), Red iron oxide (E172), Yellow iron oxide (E172), carboxymethylamylum sodium type A, precirole.
6. Pregnant;
7. Breast feeding ;
8. Having used opioids 10 days prior to the start of treatment;
9. Using itch medication other than the study medication and unwilling to stop;
10. Psychiatric disorder;
11. Other disease associated with itch (eg excema, atopic dermatitis, cholestatic pruritus);
12. Insufficiently proficient in Dutch to give informed consent and/or fill out the questionnaires
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1001 |
| NTR-old | NTR1030 |
| Ander register | : |
| ISRCTN | ISRCTN68179235 |