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

Prostatic Neoplasms Clinical Trial

Official title:

A Comparison of 2 Schedules of Meloxicam to Reduce Prostate Swelling in Permanent Seed Prostate Brachytherapy - A Randomized Phase III Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152919
• Other study ID #: UHN REB 03-0840-C
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: August 12, 2010
• Start date: February 2004
• Est. completion date: May 2009

Study information

• Verified date: August 2010
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Meloxicam

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare 2 schedules of MeloxicamTM given in the peri-operative period to reduce prostate swelling after permanent seed implantation for prostate cancer
Secondary	To determine the influence of different timing of MeloxicamTM administration on urinary toxicity and biochemical response after permanent seed implantation for prostate cancer