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

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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

This Tabular View shows the required WHO registration data elements as marked by ^†

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

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.