Clinical trial NCT05750875: Gabapentin Versus Loratadine in Uremic Pruritus
Official title: Comparison of the Efficacy of Gabapentin With Loratadine in the Treatment of Uremic Pruritus in Patients of Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pruritus
Uremia
Chronic Kidney Diseases
Keywords: Efficacy
Gabapentin
Loratadine
Uremic Pruritus
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2023-03-02
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Mean reduction in pruritus score, from baseline till 4 weeks, as measured on a numerical rating scale.
timeFrame: Four weeks
Secondary outcomes:
measure: Mean reduction in Dermatology Life Quality Index Questionnaire score, from baseline till 4 weeks.
timeFrame: Four weeks
measure: Comparison of side effects of gabapentin and loratadine, as reported by the participants.
timeFrame: Four weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: King Edward Medical University/Mayo Hospital
state: Punjab
Study officials:
affiliation: King Edward Medical University
name: Noor-Un-Nisaa Zia, MD Medicine
role: PRINCIPAL_INVESTIGATOR
References: