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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

Page last updated: August 23, 2015

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