Gabapentin Versus Loratadine in Uremic Pruritus

NCT05750875 | Completed Phase 4

• 1 other identifier: 9669/REG/KEMU/2021
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Pruritus; Uremia; Chronic Kidney Diseases

Keywords

Efficacy; Gabapentin; Loratadine; Uremic Pruritus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

  Four weeks

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

  Four weeks

Study Arms (2)

Loratadine

ACTIVE COMPARATOR

Drug: Loratadine

Gabapentin

ACTIVE COMPARATOR

Drug: Gabapentin

Interventions

Loratadine DRUG

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

Loratadine

Gabapentin DRUG

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

Gabapentin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

King Edward Medical University/Mayo Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Pruritus; Uremia; Renal Insufficiency, Chronic

Interventions

Loratadine; Gabapentin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Noor-Un-Nisaa Zia, MD Medicine

  King Edward Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Endocrinology

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 2, 2023
• Study Start: May 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)