Treatment of itch with naltrexon in patients with burns

ISRCTN	ISRCTN68179235
DOI	https://doi.org/10.1186/ISRCTN68179235
Protocol serial number	N/A
Sponsor	Martini Hospital (The Netherlands)
Funder	Association of Dutch Burn Centres (ADBC) (The Netherlands)

Submission date: 23/08/2007
Registration date: 23/08/2007
Last edited: 04/12/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A. Wieringa
Scientific

Martini Hospital
Department of Pharmacy
P.O. Box 30033
Groningen
9700 RM
Netherlands

Phone	+31 (0)50 524 5771
Email	andre.wieringa@mzh.nl

Study information

Primary study design	Interventional
Study design	Randomised, double-blind, placebo controlled, crossover group trial
Secondary study design	Randomised controlled trial
Scientific title	Treatment of itch with naltrexone in patients with burns: an explorative, randomised, double blind, placebo-controlled, cross-over clinical trial
Study acronym	BITE (Burns Itch TreatmEnt study)
Study objectives	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.
Ethics approval(s)	Ethics approval received from the local ethics board (Stichting Beoordeling Ethiek Biomedisch Onderzoek, Medisch Ethische toetsingscommissie [METC Assen]) on the 4th July 2007 (ref: MZH 2007-20).
Health condition(s) or problem(s) studied	Burns
Intervention	Patients will take either naltrexone or placebo for two weeks and are randomised to start with one or the other. Before the two 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 50 mg once daily. On the first day patients will receive two times 25 mg of naltrexone with at least one hour in between. The procedure on the first day will be mimicked where the placebo is concerned.
Intervention type	Other
Primary outcome measure(s)	1. Mean itch intensity score at endpoint, 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%
Key secondary outcome measure(s)	1. Additional aspects of itch (e.g. frequency, duration) 2. The effect of treatment as perceived by the patient, pain, and various aspects of anxiety and sleep: 2.1. Itch presence, measured at baseline 1 2.2. Demographics, measured at baseline 1 2.3. Burn injury characteristics, measured at baseline 1 2.4. Polymorphism µ-receptor (DNA), measured at intervention week 2 2.5. Blood plasma level, measured at intervention week 2 and intervention week 4 2.6. Scar: 2.6.1. Patient and Observer Scar Assessment Scale (POSAS), measured at baseline 1 and intervention week 4 2.6.2. Dermaspect, measured at baseline 1 and intervention week 4 2.7. Itch: 2.7.1. Visual Analogue Scale (VAS) measured daily throughout treatment 2.7.2. Body-Image Ideals Questionnaire (BIQ), measured at baseline 1, intervention week 1, intervention week 2, baseline 2, intervention week 3, intervention week 4 2.8. Sleep: 2.8.1. Visual Analogue Scale (VAS) measured daily throughout treatment 2.8.2. Medical Outcomes Study (MOS)-Sleep, measured at baseline 1, intervention week 1, baseline 2, intervention week 3 2.9. Pain: Visual Analogue Scale (VAS) measured daily throughout treatment 2.10. Anxiety: Hamilton Anxiety and Depression Scale (HADS), measured at baseline 1, intervention week 1, baseline 2, intervention week 3 2.11. Treatment effect: Patient Global Impression of Change (PGIC), measured at intervention 2 and intervention 4 2.12. Adverse Drug Reaction, measured daily during the intervention and wash out periods Timepoints: Baseline 1: 7 days Intervention week 1: 7 days Intervention week 2: 7 days Wash-out 1: three days Baseline 2: 7 days Intervention week 3: 7 days Intervention week 4: 7 days Wash-out 2: 3 days
Completion date	01/07/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target sample size at registration	20
Key inclusion criteria	Eligible for inclusion are patients: 1. With (almost) healed burns who have been admitted to the burn centre 2. Who are 18 years of age or older with itch 4 - 6 weeks post burn
Key exclusion criteria	Patients will be excluded when meeting one of the following exclusion criteria: 1. Total Body Surface Area (TBSA) of more than 20% 2. Liver insufficiency (in this study that means more than two times the normal range of the liver enzymes: Aspartate Aminotransferase [ASAT] greater than 80 U/L and/or Alanine Aminotransferase [ALAT] greater than 80 U/L and/or Alkaline Phosphatase [AP] greater than 250U/L and/or Gamma Glutamyl Transpeptidase [GGT] greater than 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 (e.g. eczema, atopic dermatitis, cholestatic pruritus) 12. Insufficiently proficient in Dutch to give informed consent and/or fill out the questionnaires
Date of first enrolment	01/09/2007
Date of final enrolment	01/07/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Martini Hospital

Groningen
9700 RM
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan