Montelukast for Treatment of Uremic Pruritus

September 23, 2015 updated by: Mehdi Mahmudpour, Shiraz University of Medical Sciences

Assessment of Montelukast Efficacy in the Treatment of Refractive Uremic Pruritus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: montelukast
montelukast 10 milligram, daily for 30 days
Drug: Montelukast
Placebo Comparator: placebo
Placebo one tablet for 30 days
Drug: placebo
Placebo (For Montelukast) Placebo pills manufactured for mimic 10 milligram montelukast pills

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Detailed score proposed by Duo for pruritus
Time Frame: Change from Baseline in Detailed score at 1months
Change from Baseline in Detailed score at 1months
Change from Baseline in Detailed score at 1months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Highly sensitive CRP (hs-CRP)
Time Frame: Change from Baseline in serum value at 1months
This test is a serologic biochemical test
Change from Baseline in serum value at 1months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Investigators

  • Principal Investigator: Mohammad Mehdi Sagheb, Professor, shiraz University of medical sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

September 9, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Estimate)

September 24, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.SUMS.REC.1394.32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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