Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00745199
First received: September 2, 2008
Last updated: August 17, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
End Stage Renal Disease
Pruritus
Drug: cromolyn sodium
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Study of the Effect of Oral Cromolyn Sodium on Uremic Pruritus and Serum Tryptase Levels of Hemodialysed Patients

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • pruritus [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serum tryptase level [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: May 2008
Study Completion Date: June 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients on hemodialysis with pruritus, receiving cromolyn sodium
Drug: cromolyn sodium
oral cromolyn sodium, capsule 135mg, 1 capsule 3 times daily for 8 weeks
Experimental: 2
patients on hemodialysis with pruritus, receiving placebo
Drug: placebo
capsule contains 135 mg lactose, 1 capsule 3 times daily for 8 weeks
No Intervention: 3
Patients on hemodialysis but without pruritus who do not receive any treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745199

Locations
Iran, Islamic Republic of
Shiraz University of Medical sciences, Nemazi and Faghihi Hospital
Shiraz, Fars, Iran, Islamic Republic of, 71345
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Study Director: Ghazal Vessal, PharmD, BCPS Shiraz University of Medical Sciences
Principal Investigator: Mohammad Mahdi Sagheb, MD Shiraz University of Medical Sciences
Principal Investigator: Saman Shilian, Pharm student Shiraz University of Medical Sciences
  More Information

No publications provided

Responsible Party: Dr.Ghazal Vessal PharmD, BCPS, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00745199     History of Changes
Other Study ID Numbers: 4146
Study First Received: September 2, 2008
Last Updated: August 17, 2009
Health Authority: Iran: Ethics Committee

Keywords provided by Shiraz University of Medical Sciences:
End Stage Renal Disease
Cromolyn Sodium
Pruritus
Tryptase

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Pruritus
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Skin Diseases
Skin Manifestations
Signs and Symptoms
Cromolyn Sodium
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014