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

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

December 23, 2005

Start Date ^ICMJE

February 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To compare 2 schedules of MeloxicamTM given in the peri-operative period to reduce prostate swelling after permanent seed implantation for prostate cancer

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00152919 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To determine the influence of different timing of MeloxicamTM administration on urinary toxicity and biochemical response after permanent seed implantation for prostate cancer

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment

Condition ^ICMJE

Prostatic Neoplasms

Intervention ^ICMJE

Drug: Meloxicam

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

100

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact: Juanita Crook, MD

416-946-2919

juanita.crook@rmp.uhn.on.ca

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00152919

Responsible Party

Study ID Numbers ^ICMJE

UHN REB 03-0840-C

Study Sponsor ^ICMJE

University Health Network, Toronto

Collaborators ^ICMJE

Princess Margaret Hospital, Canada

Investigators ^ICMJE

Principal Investigator:

Juanita Crook, MD

Princess Margaret Hospital, Canada

Information Provided By

University Health Network, Toronto

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP