Treatment of itch with naltrexon in patients with burns
| ISRCTN | ISRCTN68179235 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68179235 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Martini Hospital
Department of Pharmacy
P.O. Box 30033
Groningen
9700 RM
Netherlands
| Phone | +31 (0)50 524 5771 |
|---|---|
| andre.wieringa@mzh.nl |
Study information
| Study design | Randomised, double-blind, placebo controlled, crossover group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/09/2007 |
| Completion date | 01/07/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | 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
9700 RM
Netherlands
Sponsor information
Martini Hospital (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Surgery
P.O. Box 30033
Groningen
9700 RM
Netherlands
"ROR" |
https://ror.org/017b69w10 |
|---|
Funders
Funder type
Research organisation
Association of Dutch Burn Centres (ADBC) (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
