Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus
Information source: Shiraz University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: End Stage Renal Disease; Pruritus
Intervention: cromolyn sodium (Drug); placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Shiraz University of Medical Sciences Official(s) and/or principal investigator(s): Ghazal Vessal, PharmD, BCPS, Study Director, Affiliation: Shiraz University of Medical Sciences Mohammad Mahdi Sagheb, MD, Principal Investigator, Affiliation: Shiraz University of Medical Sciences Saman Shilian, Pharm student, Principal Investigator, Affiliation: Shiraz University of Medical Sciences
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.
Clinical Details
Official title: Phase II Study of the Effect of Oral Cromolyn Sodium on Uremic Pruritus and Serum Tryptase Levels of Hemodialysed Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: pruritus
Secondary outcome: serum tryptase level
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Shiraz University of Medical sciences, Nemazi and Faghihi Hospital, Shiraz, Fars 71345, Iran, Islamic Republic of
Additional Information
Starting date: May 2008
Last updated: August 17, 2009
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