Gabapentin Versus Loratadine in Uremic Pruritus

NCT ID: NCT05750875

Last Updated: 2023-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-10-31

Brief 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.

Detailed 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.

Conditions

Pruritus; Uremia; Chronic Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Loratadine

Group Type: ACTIVE_COMPARATOR

Loratadine

Intervention Type: DRUG

Participants were given loratadine 10mg, oral, daily, for 4 weeks

Gabapentin

Group Type: ACTIVE_COMPARATOR

Gabapentin

Intervention Type: DRUG

Participants were given gabapentin 100mg, oral, daily, for 4 weeks

Interventions

Loratadine

Participants were given loratadine 10mg, oral, daily, for 4 weeks

Intervention Type: DRUG

Gabapentin

Participants were given gabapentin 100mg, oral, daily, for 4 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King Edward Medical University

OTHER

Sponsor Role: lead

Responsible Party

Fawad Ahmad Randhawa

Associate Professor of Endocrinology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noor-Un-Nisaa Zia, MD Medicine

Role: PRINCIPAL_INVESTIGATOR

King Edward Medical University

Locations

King Edward Medical University/Mayo Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Provided Documents

Document Type: Study Protocol and Informed Consent Form

View Document

Other Identifiers

9669/REG/KEMU/2021

Identifier Type: -

Identifier Source: org_study_id