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Mobicox: Study of Meloxicam to Reduce Prostate Swelling in Permanent Seed Prostate Brachytherapy

This study is currently recruiting participants.
Study NCT00152919.   Last updated on December 23, 2005.   Information provided by University Health Network, Toronto

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Descriptive Information Fields
Brief Title  Mobicox: Study of Meloxicam to Reduce Prostate Swelling in Permanent Seed Prostate Brachytherapy
Official Title  A Comparison of 2 Schedules of Meloxicam to Reduce Prostate Swelling in Permanent Seed Prostate Brachytherapy - A Randomized Phase III Trial
Brief Summary

Swelling of the prostate can occur during and after a brachytherapy. This swelling can cause urinary problems ranging from difficulty voiding to urinary retention. The purpose of this study is to investigate whether Mobicox started one week before brachytherapy and then continued afterwards is more effective in reducing the risk of needing a catheter than Mobicox given only afterwards.

Detailed Description
Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary Outcome Measure  To compare 2 schedules of MeloxicamTM given in the peri-operative period to reduce prostate swelling after permanent seed implantation for prostate cancer
Secondary Outcome Measure  To determine the influence of different timing of MeloxicamTM administration on urinary toxicity and biochemical response after permanent seed implantation for prostate cancer
Condition  Prostatic Neoplasms
Intervention  Drug: Meloxicam
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  100
Start Date  February 2004
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • Eligible to receive prostate brachytherapy as per the Ontario Provincial Guidelines will be eligible for this study (i.e. prostate specific antigen [PSA] < 10, Gleason score <7, Stage <= T2a)

Exclusion Criteria:

  • Patients already taking anti-inflammatory drugs
  • Patients with allergic-type reactions, including asthma and urticaria, to aspirin or nonsteroidal anti-inflammatory agents (see product information)
Gender Male
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Juanita Crook, MD     416-946-2919     juanita.crook@rmp.uhn.on.ca    
Location Countries  Canada
Administrative Information Fields
NCT ID  NCT00152919
Organization ID UHN REB 03-0840-C
Secondary IDs ††
Study Sponsor  University Health Network, Toronto
Collaborators †† Princess Margaret Hospital, Canada
Investigators 
Principal Investigator:     Juanita Crook, MD     Princess Margaret Hospital, Canada    
Information Provided By University Health Network, Toronto
Verification Date September 2005
First Received Date  September 8, 2005
Last Updated Date December 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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