Haemodialysis subjects with uremic itch.
Conditions
Interventions
Pharmaceutical Form: Capsule, hard
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of
Sponsors
AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Presence of a history of itch>4weeks. 2. Male or female >18 years of age. 3. Written informed consent, given before any study related procedure (Appendix 5). 4. For women, willingness to use adequate contraception. This requirement does not apply to surgically sterile subjects or to subjects who are postmenopausal for at least 2 years. 5. Women of childbearing potential must have a negative serum pregnancy test at intial screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any condition including laboratory findings and findings in the medical history or in the pre-study assessments, that in the opinion of the investigator constitute a risk or a contraindication for participation in the study or that could interfere with the study objectives, conduction or evaluation. 2. Patients with itch before kidney failure. 3. Patients with other dermatologic pathologies (atopic dermatitis, allergy, other). 4. Patients with hypereosinophilia (>500/mm3) or elevation of serum IgE (>120 UI/ml). 5. Patients with elevated Calcium-Phosphorus product (>60), elevated serum biliary acids (>6 micmolACBIL/l). 6. Haemodialysis depuration score (KT/V) calculated with the simplified Daugirdas formula <1. 7. Patients treated with only two weekly heamodialysis session. 8. Patients with diagnosed comorbidities such as cholestasis, tumour, rheumatic diseases. 9. Patients in treatment with anti-epileptic drugs. 10. Patients that are currently treated with steroids, opioids, anti-histamines or other therapy that could interfere with itch therapy (e.g. Ultraviolet therapy). 11. Patients not able to give informed consent or not able to answer adequately to questions regarding itch. 12. Hypersensitivity to any of the components of the study drug 13. Active alcohol or drug abuse or history of alcohol or drug abuse in the last 6 months 14. Breastfeeding or pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy of gabapentin 100mg/HD or 300 mg/HD compared with placebo in haemodialysis subjects with uremic itch.;Secondary Objective: To evaluate the safety and tolerability of gabapentin at the scheduled doses compared with placebo.;Primary end point(s): To evaluate the change of itch severity using a pruritus score based on a visual analogue scale (VAS) from baseline at the two different scheduled doses. | — |
Countries
Italy
Outcome results
None listed