A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY OF DIFFERENT GABAPENTIN DOSES IN HAEMODIALYSIS PATIENTS WITH UREMIC PRURITUS. - ND

• Conditions: Haemodialysis subjects with uremic itch.

• Registration Number: EUCTR2009-010437-50-IT
• Lead Sponsor: AZIENDA OSPEDALIERA ARCISPEDALE S. MARIA NUOVA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-27
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified