Gabapentin Versus Loratadine in Uremic Pruritus

Chronic Kidney Diseases Clinical Trial

Official title:

Comparison of the Efficacy of Gabapentin With Loratadine in the Treatment of Uremic Pruritus in Patients of Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05750875
• Other study ID #: 9669/REG/KEMU/2021
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: March 2023
• Source: King Edward Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the efficacy of gabapentin with loratadine in reducing the severity of uremic pruritus in patients of chronic kidney disease and to compare the side effects of both drugs. The main questions it aims to answer are:

• Which drug (gabapentin versus loratadine) is more effective in reducing the severity of uremic pruritus?

• Which drug (gabapentin versus loratadine) has fewer side effects?

Participants were divided into two groups.Group A received loratadine 10mg daily and group B received gabapentin 100mg daily. Both groups were given treatment for 4 weeks.

• Participants were asked to grade the severity of pruritus on a numerical rating scale and also answer the Dermatology Life Quality Index Questionnaire (DLQI)

• Participants were also asked to report any side effects, if occurred.

Researchers compared both groups with regards to improvement in pruritus severity, DLQI score and side effects.

Description:

Informed written consent was taken from all the participants. Participants were asked to discontinue any topical or systemic antipruritic drugs, for least 1 week prior to the study. Demographic, clinical and laboratory data (complete blood count, renal function tests, liver function tests, serum electrolytes and ultrasound abdomen) was evaluated at baseline. Glomerular Filtration Rate (GFR) and stage of chronic kidney disease was calculated. Participants were randomly allocated to two groups. One group received loratadine 10mg daily and the other received gabapentin 100mg daily. Those participants undergoing hemodialysis received their respective dose after the dialysis session. Both groups were given treatment for 4 weeks. Participants were asked to grade the severity of pruritus on a numerical rating scale and also answer the Dermatology Life Quality Index Questionnaire.These proformas were filled once at the start of the study, at 2 weeks and then at the end of study i.e. 4 weeks. Participants were also asked to report any adverse events, if occurred.

The Statistical Package for the Social Sciences (SPSS) version 25.0 was used to analyze the data. Qualitative data (like gender, dialysis status, etc.) was expressed in the form of frequency and percentages while quantitative data (like age, weight, serum creatinine levels, etc.) was represented as mean and standard deviations (Mean±SD). The reduction in scores of numerical rating scale and Dermatology Life Quality Index Questionnaire was calculated from baseline. Mean reduction in scores were compared between the two groups and independent sample t-test was applied. p-value <0.05 was considered as significant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Chronic kidney disease, stage 3 and above, irrespective of dialysis status

• Persistent pruritus, of moderate to very severe intensity (= 4 points on numerical rating scale), occurring at least 3 times a week, for at least 2 weeks, in a 1-month period.

Exclusion Criteria:

• Chronic skin conditions such as eczema, psoriasis, etc.

• Pruritus due to any other cause, such as metabolic abnormalities, liver disease, etc.

• History of drugs causing pruritus such as opioids, etc

• Pregnant patients

• Preceding history of allergy to either gabapentin or loratadine.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Pruritus
• Renal Insufficiency, Chronic
• Uremia

Intervention

Drug:
• Loratadine
Participants were given loratadine 10mg, oral, daily, for 4 weeks
• Gabapentin
Participants were given gabapentin 100mg, oral, daily, for 4 weeks

Locations

Country	Name	City	State
Pakistan	King Edward Medical University/Mayo Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean reduction in pruritus score, from baseline till 4 weeks, as measured on a numerical rating scale.	Reduction in pruritus score as measured on a numerical rating scale, numbered between '0' (corresponding to no itch) and '10' (the worst imaginable itch).	Four weeks
Secondary	Mean reduction in Dermatology Life Quality Index Questionnaire score, from baseline till 4 weeks.	Dermatology Life Quality Index Questionnaire score ranging from from 0 (no impairment of life quality) to 30 (maximum impairment).	Four weeks
Secondary	Comparison of side effects of gabapentin and loratadine, as reported by the participants.		Four weeks