- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00745199
Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus
August 17, 2009 updated by: Shiraz University of Medical Sciences
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fars
-
Shiraz, Fars, Iran, Islamic Republic of, 71345
- Shiraz University of Medical sciences, Nemazi and Faghihi Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Patients on hemodialysis with pruritus, receiving cromolyn sodium
|
oral cromolyn sodium, capsule 135mg, 1 capsule 3 times daily for 8 weeks
|
Experimental: 2
patients on hemodialysis with pruritus, receiving 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pruritus
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum tryptase level
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
November 1, 2008
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
September 2, 2008
First Submitted That Met QC Criteria
September 2, 2008
First Posted (Estimate)
September 3, 2008
Study Record Updates
Last Update Posted (Estimate)
August 18, 2009
Last Update Submitted That Met QC Criteria
August 17, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Urologic Diseases
- Renal Insufficiency
- Renal Insufficiency, Chronic
- Skin Manifestations
- Kidney Diseases
- Kidney Failure, Chronic
- Pruritus
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Immunologic Factors
- Anti-Asthmatic Agents
- Respiratory System Agents
- Mast Cell Stabilizers
- Cromolyn Sodium
Other Study ID Numbers
- 4146
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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