Mobicox: Study of Meloxicam to Reduce Prostate Swelling in Permanent Seed Prostate Brachytherapy
Information source: University Health Network, Toronto
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Prostatic Neoplasms
Intervention: Meloxicam (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University Health Network, Toronto Official(s) and/or principal investigator(s):
Juanita Crook, MD, Principal Investigator, Affiliation: Princess Margaret Hospital, Canada
Overall contact:
Juanita Crook, MD, Phone: 416-946-2919, Email: juanita.crook@rmp.uhn.on.ca
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.
Clinical Details
Official title: A Comparison of 2 Schedules of Meloxicam to Reduce Prostate Swelling in Permanent Seed Prostate Brachytherapy - A Randomized Phase III Trial
Study design: Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: 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: To determine the influence of different timing of MeloxicamTM administration on urinary toxicity and biochemical response after permanent seed implantation for prostate cancer
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
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)
Locations and Contacts
Juanita Crook, MD, Phone: 416-946-2919, Email: juanita.crook@rmp.uhn.on.ca
Princess Margaret Hospital, Toronto, Ontario M5G 2M9, Canada; Recruiting
Juanita Crook, MD, Phone: 416-946-2919, Email: juanita.crook@rmp.uhn.on.ca
Additional Information
Starting date: February 2004
Last updated: December 23, 2005
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