Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus
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...
Brief Summary
Official Title: “Phase II Study of the Effect of Oral Cromolyn Sodium on Uremic Pruritus and Serum Tryptase Levels of Hemodialysed Patients”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: November 2008
Intervention(s) in this Clinical Trial
- 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 in this Clinical Trial
- 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.
Outcome Measures for this Clinical Trial
Primary Measures
- pruritus
- Time Frame: 3 months
Safety Issue?: No
- Time Frame: 3 months
Secondary Measures
- serum tryptase level
- Time Frame: 4 months
Safety Issue?: No
- Time Frame: 4 months
Criteria for Participation 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 for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Shiraz University of Medical Sciences Other
Overall Clinical Trial Officials and Contacts
Ghazal Vessal, PharmD, BCPS Study Director Shiraz University of Medical Sciences
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00745199
Study ID Number: 4146
ClinicalTrials.gov Identifier: NCT00745199
Health Authority: Iran: Ethics Committee
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00745199
