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. The nature of the association(s) of the - reduction of the - intensity of itch with sleep and anxiety in…
ID
Source
Brief title
Condition
- Other condition
- Epidermal and dermal conditions
Synonym
Health condition
jeuk bij patienten met brandwonden
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean itch intensity score at end point, defined as the mean of the last 7 diary
entries while the patient is receiving study medication.
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%
Secondary outcome
Additional aspects of itch (e.g. frequency, duration), the effect of treatment
as perceived by the patient, pain, and various aspects of anxiety and sleep.
Background summary
It is clinically well known that itch (pruritus) is one of the most disturbing
physical complaints in persons with burns. Like in many inflammatory skin
diseases, itch has been shown to affect the quality of life of persons with
burns in aspects such as sleep disturbances, impairments of daily activities,
and psychosocial well-being. Despite these reports and the urgent clinical need
to relieve the suffering from itch, it is still one of the unresolved
scar-related problems in burn care practice.
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, we want to
investigate the effectiveness of naltrexone. Via opioid receptors in the
central and peripheral nervous system endogen opioids are modifying the
perception of itch. The opioid antagonist naltrexone of the µ-, *-, en δ
receptors will suppress the opioid pathway and could therefore be effective in
the treatment of itch in patients with burn wounds. Naltrexone has already been
used with success in cholestatic pruritus and different dermatological forms of
pruritus.
Study objective
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. The nature of
the association(s) of the - reduction of the - intensity of itch with sleep and
anxiety in particular will also be analysed.
Study design
This study concerns an explorative, randomised, double blind,
placebo-controlled, cross-over clinical trial. In total 20 patients will be
included.
Intervention
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.
Study burden and risks
Side-effects may occur when taking naltrexone, these are mostly mild and
transient. Furthermore, patients are asked to fill out a trial dairy on a daily
basis and a blood sample is taken once. In total, patients have to come to the
hospital 3 times because of their participation in this trial. However, every
effort will be made to let these visits coincide with their regular clinical
follow-up visits.
Till now there is no effective treatment of itch in patients with burn wounds.
Many studies with significant declines in itch scores have been performed with
naltrexone for treatment of different origins of pruritus (e.g. cholestatic and
dermatological pruritus) with minor side effects.
There have not been any studies of naltrexone treatment in patients with burn
wounds and itch. Naltrexone seems a promising drug for the treatment of itch in
patients with burn wounds. When naltrexone is effective it can be used
worldwide in patients with burn wounds to treat itch.
Postbus 30033
9700 RM Groningen
NL
Postbus 30033
9700 RM Groningen
NL
Listed location countries
Age
Inclusion criteria
Eligible for inclusion are patients with (almost) healed burns who have been admitted to the burn centre , and are 18 years of age or older with itch 4-6 weeks postburn.
Exclusion criteria
Patients will be excluded when meeting one of the following exclusion criteria:
•TBSA of more than 20%
•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)
•acute hepatitis
•history of drug/alcohol abuse
•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.
•pregnant
•breast feeding
•having used opioids 10 days prior to the start of treatment
•using itch medication other than the study medication and unwilling to stop
•psychiatric disorder
•other disease associated with itch (eg excema, atopic dermatitis, cholestatic pruritus)
•insufficiently proficient in Dutch to give informed consent and/or fill out the questionnaires
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-002638-12-NL |
| CCMO | NL17849.056.07 |