Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Montelukast for Treatment of Uremic Pruritus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02559388
Recruitment Status : Completed
First Posted : September 24, 2015
Last Update Posted : September 24, 2015
Sponsor:
Information provided by (Responsible Party):
Mehdi Mahmudpour, Shiraz University of Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Drug: Montelukast Drug: placebo Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of Montelukast Efficacy in the Treatment of Refractive Uremic Pruritus
Study Start Date : April 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Highly sensitive CRP (hs-CRP) [ Time Frame: Change from Baseline in serum value at 1months ]
    This test is a serologic biochemical test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559388


Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Layout table for investigator information
Principal Investigator: Mohammad Mehdi Sagheb, Professor Shiraz University of Medical Sciences
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Mehdi Mahmudpour, Fellowship of Nephrology, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02559388    
Other Study ID Numbers: IR.SUMS.REC.1394.32
First Posted: September 24, 2015    Key Record Dates
Last Update Posted: September 24, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Insufficiency
Renal Insufficiency, Chronic
Pruritus
Kidney Diseases
Urologic Diseases
Skin Diseases
Skin Manifestations
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action