Montelukast for Treatment of Uremic Pruritus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this study hemodialysis patients that underwent dialysis thrice weekly screen for uremic pruritus and 80 patients that at least have refractive pruritus that lead to sleep and daily activity disorders enroll in this study. These patients should have at least a course of therapy without proper response. After proper informing patients and taking testimonial patients enter to study. Then patients randomized in case and control group. In case group, patients took montelukast 10 milligram daily and in control group took placebo for 30 days. Other antipruritic or antiinflammatory medication has been stopped one week prior to starting treatment. Calcium, phosphorous, urea, creatinine, highly sensitive CRP (hsCRP), Parathyroid Hormone (PTH), hemoglobin and kt/V were measured at beginning and at end of study. pruritus severity assessed by Detailed Pruritus Score that introduced by Duo and Visual Analogue Score in beginning and at end of study in both group. Sleep disorder score and its severity added to crude score at beginning and end of study and change of measures analyzed.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of MT-9938 for Treatment of Uremic Pruritus in Subjects With End-stage Renal Disease Receiving Hemodialysis

NCT01660243

Uremic Pruritus

TERMINATED PHASE2

A Multi-site Bridging Study of Nalfurafine Hydrochloride Orally Disintegrating Tablet

NCT04728984

Uremic Pruritus

UNKNOWN PHASE3

Treatment of Uremic Pruritus With PA101B

NCT02696499

Uremic Pruritus

COMPLETED PHASE2

A Study of Thalidomide in the Treatment of Refractory Uremic Pruritus

NCT05525234

Haemodialysis Uremic Pruritus Thalidomide

UNKNOWN PHASE4

A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.

NCT03802617

Uremic Pruritus

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Montelukast is an antileukotrien receptor antagonist that seems to be effective as an antipruritic medication via blocking inflammatory pathways.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Insufficiency, Chronic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

montelukast

montelukast 10 milligram, daily for 30 days

Group Type ACTIVE_COMPARATOR

Montelukast

Intervention Type DRUG

placebo

Placebo one tablet for 30 days

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Placebo (For Montelukast) Placebo pills manufactured for mimic 10 milligram montelukast pills

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Montelukast

Intervention Type DRUG

placebo

Placebo (For Montelukast) Placebo pills manufactured for mimic 10 milligram montelukast pills

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* hemodialysis patients that refered to dialysis centers and at least on hemodialysis thrice weekly
* presence of uremic pruritus
* patients that at least had refractive pruritus that lead to sleep disorders or compromised daily activities
* patients should took a course of antipruritic treatment with no proper response

Exclusion Criteria

* presence of pruritus less than three months
* kt/V less than 1.2
* presence of pruritus due to other cause other than uremic state
* presence of other pruritic diseases; malignancies; cholestasis; hepatitis B and C infection
* treatment with corticosteroid
* presence of anemia with hemoglobin less than 10

Eligible Sex

ALL

Accepts Healthy Volunteers

No