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

This study has been completed.

First Received on September 8, 2005. Last Updated on August 12, 2010 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:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

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

Locations

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9

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 by University Health Network, Toronto

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Crook J, Patil N, Wallace K, Borg J, Zhou D, Ma C, Pond G. A phase III randomized trial of the timing of meloxicam with iodine-125 prostate brachytherapy. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):496-501. Epub 2010 Mar 28.

ClinicalTrials.gov Identifier:	NCT00152919 History of Changes
Other Study ID Numbers:	UHN REB 03-0840-C
Study First Received:	September 8, 2005
Last Updated:	August 12, 2010
Health Authority:	Canada: Ethics Review Committee

Additional relevant MeSH terms:

Neoplasms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012