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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00152919
First Posted: September 9, 2005
Last Update Posted: August 13, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00152919     History of Changes
Other Study ID Numbers: UHN REB 03-0840-C
First Submitted: September 8, 2005
First Posted: September 9, 2005
Last Update Posted: August 13, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action