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Completed

NCT Number: NCT05750875

Gabapentin Versus Loratadine in Uremic Pruritus

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.

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Key information

Conditions

Pruritus Chronic Disease Chronic Kidney Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Uremia Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

King Edward Medical University/Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Loratadine

Drug

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

Gabapentin

Drug

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

Primary outcomes

  1. Mean reduction in pruritus score, from baseline till 4 weeks, as measured on a numerical rating scale.

    Time frame: Four weeks

    Reduction in pruritus score as measured on a numerical rating scale, numbered between '0' (corresponding to no itch) and '10' (the worst imaginable itch).

Secondary outcomes

  1. Mean reduction in Dermatology Life Quality Index Questionnaire score, from baseline till 4 weeks.

    Time frame: Four weeks

    Dermatology Life Quality Index Questionnaire score ranging from from 0 (no impairment of life quality) to 30 (maximum impairment).

  2. Comparison of side effects of gabapentin and loratadine, as reported by the participants.

    Time frame: Four weeks

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2023
Registry last updated
Mar 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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