Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/08/2007
Date assigned
23/08/2007
Last edited
04/12/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A. Wieringa

ORCID ID

Contact details

Martini Hospital
Department of Pharmacy
P.O. Box 30033
Groningen
9700 RM
Netherlands
+31 (0)50 524 5771
andre.wieringa@mzh.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Treatment of itch with naltrexone in patients with burns: an explorative, randomised, double blind, placebo-controlled, cross-over clinical trial

Acronym

BITE (Burns Itch TreatmEnt study)

Study hypothesis

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

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).

Study design

Randomised, double-blind, placebo controlled, crossover group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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%

Secondary outcome measures

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

Overall trial start date

01/09/2007

Overall trial end date

01/07/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

20

Participant 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

Recruitment start date

01/09/2007

Recruitment end date

01/07/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Martini Hospital
Groningen
9700 RM
Netherlands

Sponsor information

Organisation

Martini Hospital (The Netherlands)

Sponsor details

Department of Surgery
P.O. Box 30033
Groningen
9700 RM
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Association of Dutch Burn Centres (ADBC) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes