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

This study has been completed.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00152919
First received: September 8, 2005
Last updated: August 12, 2010
Last verified: August 2010
History of Changes
  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: 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:

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):

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 May 16, 2013