Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus

Overview

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.

Full Title of Study: “Phase II Study of the Effect of Oral Cromolyn Sodium on Uremic Pruritus and Serum Tryptase Levels of Hemodialysed Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2008

Interventions

  • Drug: cromolyn sodium
    • oral cromolyn sodium, capsule 135mg, 1 capsule 3 times daily for 8 weeks
  • Drug: placebo
    • capsule contains 135 mg lactose, 1 capsule 3 times daily for 8 weeks

Arms, Groups and Cohorts

  • Experimental: 1
    • Patients on hemodialysis with pruritus, receiving cromolyn sodium
  • Experimental: 2
    • patients on hemodialysis with pruritus, receiving placebo
  • No Intervention: 3
    • Patients on hemodialysis but without pruritus who do not receive any treatment.

Clinical Trial Outcome Measures

Primary Measures

  • pruritus
    • Time Frame: 3 months

Secondary Measures

  • serum tryptase level
    • Time Frame: 4 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shiraz University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Dr.Ghazal Vessal PharmD, BCPS, Shiraz University of Medical Sciences
  • Overall Official(s)
    • Ghazal Vessal, PharmD, BCPS, Study Director, Shiraz University of Medical Sciences
    • Mohammad Mahdi Sagheb, MD, Principal Investigator, Shiraz University of Medical Sciences
    • Saman Shilian, Pharm student, Principal Investigator, Shiraz University of Medical Sciences

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