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Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus

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ClinicalTrials.gov Identifier: NCT00745199
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : August 18, 2009
Information provided by:

Study Description
Brief Summary:
Pruritus is a major disorder among the skin derangements in advanced renal failure. Recent information suggests that interactions between dermal mast cells and distal ends of nonmyelinated C fibers may be important in the precipitation and regulation of the sensory stimuli.Patients having uremic pruritus have been noted to have increased levels of plasma histamine and tryptase as well as increased numbers of dermal mast cells.Cromolyn sodium is a mast cell stabilizing agent that inhibits degranulation of mast cells and the release of histamine, tryptase, and leukotrienes. It is hypothesized that oral cromolyn sodium may attenuate uremic pruritus by decreasing serum tryptase level.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Pruritus Drug: cromolyn sodium Drug: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study of the Effect of Oral Cromolyn Sodium on Uremic Pruritus and Serum Tryptase Levels of Hemodialysed Patients
Study Start Date : May 2008
Primary Completion Date : November 2008
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Patients on hemodialysis with pruritus, receiving cromolyn sodium
Drug: cromolyn sodium
oral cromolyn sodium, capsule 135mg, 1 capsule 3 times daily for 8 weeks
Experimental: 2
patients on hemodialysis with pruritus, receiving placebo
Drug: placebo
capsule contains 135 mg lactose, 1 capsule 3 times daily for 8 weeks
No Intervention: 3
Patients on hemodialysis but without pruritus who do not receive any treatment.

Outcome Measures

Primary Outcome Measures :
  1. pruritus [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. serum tryptase level [ Time Frame: 4 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Hemodialysis patients > 18 yo suffering from pruritus for at least 6 weeks, and who have not responded to other drugs
  • Willing and able to give informed concent

Exclusion Criteria:

  • Known dermatologic, liver, metabolic disease, or any other disease or condition other than ESRD that causes pruritus
  • Lactase deficiency
Contacts and Locations

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): NCT00745199

Iran, Islamic Republic of
Shiraz University of Medical sciences, Nemazi and Faghihi Hospital
Shiraz, Fars, Iran, Islamic Republic of, 71345
Sponsors and Collaborators
Shiraz University of Medical Sciences
Study Director: Ghazal Vessal, PharmD, BCPS Shiraz University of Medical Sciences
Principal Investigator: Mohammad Mahdi Sagheb, MD Shiraz University of Medical Sciences
Principal Investigator: Saman Shilian, Pharm student Shiraz University of Medical Sciences
More Information

Responsible Party: Dr.Ghazal Vessal PharmD, BCPS, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00745199     History of Changes
Other Study ID Numbers: 4146
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: August 18, 2009
Last Verified: August 2009

Keywords provided by Shiraz University of Medical Sciences:
End Stage Renal Disease
Cromolyn Sodium

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Skin Diseases
Skin Manifestations
Signs and Symptoms
Cromolyn Sodium
Anti-Asthmatic Agents
Respiratory System Agents