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Pilot Study Effect of Sulfasalazine on Glutamate Levels by(Magnetic Resonance Spectroscopy)MRS in Patients With Glioma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Louis Burt Nabors, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01577966
First received: April 11, 2012
Last updated: October 16, 2016
Last verified: July 2016
Results First Received: July 19, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Brain Tumor
Intervention: Drug: Sulfasalazine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sulfasalazine Sulfasalazine

Participant Flow:   Overall Study
    Sulfasalazine
STARTED   9 
COMPLETED   9 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Sulfasalazine

Sulfasalazine: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety

Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA.


Baseline Measures
   Sulfasalazine 
Overall Participants Analyzed 
[Units: Participants]
 9 
Age 
[Units: Years]
Mean (Full Range)
 43 
 (25 to 69) 
Gender 
[Units: Participants]
 
Female   4 
Male   5 
Region of Enrollment 
[Units: Participants]
 
United States   9 


  Outcome Measures

1.  Primary:   Percent Decrease in Central Nervous System Bioavailability of Sulfasalazine   [ Time Frame: up to 2 years post baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Burt Nabors, MD
Organization: UAB
phone: 205-934-2424
e-mail: bnabors@uabmc.edu



Responsible Party: Louis Burt Nabors, MD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01577966     History of Changes
Other Study ID Numbers: UAB 1108
Study First Received: April 11, 2012
Results First Received: July 19, 2016
Last Updated: October 16, 2016
Health Authority: United States: Food and Drug Administration