Gabapentin and dexclorfeniramine in the treatment of pruritus in hemodialysis patients

Not Applicable

• Conditions: C17.800.685; Chronic Renal Insufficiency , hemodialysis, uremic pruritus.

• Registration Number: RBR-4rxr2c
• Lead Sponsor: Faculdade de Medicina de Botucatu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-11
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Sign the consent form; Age above 18 years, of both genders; chronic renal insufficiency stage 5 on hemodialysis for at least 3 months; persistent pruritus of any intensity that occurs at least three times per week with a duration of 30 days or more; no use of topical antipruritic medications and / or systemic at least one week before start of study

Exclusion Criteria

Chronic skin diseases (allergic, infectious and parasitic); Chronic liver disease; Internal malignant disease; Use of opioids, antihistamines or corticosteroids.
the participants Will be discontinued if: withdrawal of consent; using other treatments for pruritus not recommended in this protocol and serious adverse events

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Decreased of pruritus score, by VAS (Visual Analog Scale), and improving the quality of life measured by DLQI (Dermatology Life Quality Index) after treatment with gabapentin and dexclorfeniramina;<br><br>The VAS and DLQI will be applied before treatment (T0), after treatment with emollient (after 15 days -T15) and after oral treatment with gabapentin or dexchlorpheniramine (after 36 days - T36)

Secondary Outcome Measures

Name	Time	Method
1.Decreased of pruritus score, by VAS (Visual Analog Scale), and improving the quality of life measured by DLQI (Dermatology Life Quality Index) after treatment with emollient.<br>2.Assessment of adverse events<br><br>The VAS and DLQI will be applied before treatment (T0), after treatment with emollient (15 days - T15) and after oral treatment with gabapentin or dexchlorpheniramine (36 days -T36).