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

This study is currently recruiting participants.

Verified by University Health Network, Toronto, September 2005

First Received: September 8, 2005 Last Updated: December 23, 2005 History of Changes

Sponsor:	University Health Network, Toronto
Collaborator:	Princess Margaret Hospital, Canada
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00152919

Purpose

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.

Condition	Intervention	Phase
Prostatic Neoplasms	Drug: Meloxicam	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A Comparison of 2 Schedules of Meloxicam to Reduce Prostate Swelling in Permanent Seed Prostate Brachytherapy - A Randomized Phase III Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Edema Prostate Cancer

Drug Information available for: Meloxicam

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	100
Study Start Date:	February 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152919

Contacts

Contact: Juanita Crook, MD

416-946-2919

juanita.crook@rmp.uhn.on.ca

Locations

Canada, Ontario
Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Juanita Crook, MD 416-946-2919 juanita.crook@rmp.uhn.on.ca

Sponsors and Collaborators

University Health Network, Toronto

Princess Margaret Hospital, Canada

Investigators

Principal Investigator:

Juanita Crook, MD

Princess Margaret Hospital, Canada

More Information

No publications provided

Study ID Numbers:	UHN REB 03-0840-C
Study First Received:	September 8, 2005
Last Updated:	December 23, 2005
ClinicalTrials.gov Identifier:	NCT00152919 History of Changes
Health Authority:	Canada: Ethics Review Committee

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Genital Neoplasms, Male
Prostatic Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Meloxicam
Enzyme Inhibitors
Urogenital Neoplasms
Genital Diseases, Male
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010