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Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus

NCT00745199 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2009-08-18

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Shiraz University of Medical Sciences

    lead OTHER

Principal Investigators

  • Ghazal Vessal, PharmD, BCPS · Shiraz University of Medical Sciences

  • Mohammad Mahdi Sagheb, MD · Shiraz University of Medical Sciences

  • Saman Shilian, Pharm student · Shiraz University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2008-11-30
Completion
2009-06-30

Countries

  • Iran

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00745199 on ClinicalTrials.gov