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VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate

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.
 
ClinicalTrials.gov Identifier: NCT01777217
Recruitment Status : Terminated (Terminated)
First Posted : January 28, 2013
Results First Posted : January 16, 2015
Last Update Posted : January 16, 2015
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Advanced Research Network

Study Description
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Brief Summary:
The purpose of this study is to determine if Vesicare (Solifenacin succinate) is effective in treating over-active bladder symptoms during radiation therapy of the prostate.

Condition or disease Intervention/treatment Phase
Over-Active Bladder Drug: Solifenacin succinate Drug: Placebo Phase 4

Detailed Description:
This is a randomized double blind placebo controlled flexible dose 12 week study. Following screening, subjects will receive their first dose of study medication following completion of AUASS questionnaire on the first day of radiation treatment (baseline) and will continue for twelve weeks. Subjects will be started on 5 mg of study medication. The AUASS will be completed at baseline, weeks 4, 8 and 12. A 16 week visit conducted over a phone interview.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study to Assess the Safety and Efficacy of Solifenacin (VESIcare) for Improving Urinary and Bladder Functions in Patients Undergoing Radiation Therapy of the Prostate
Study Start Date : February 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: solifenacin succinate
Solifenacin succinate, 5mg or 10 mg once daily
 Drug: Solifenacin succinate
IGRT with VESIcare
Other Name: VESIcare
Placebo Comparator: Placebo
Drug: Placebo oral
 Drug: Placebo
IGRT with placebo
Other Name: Control


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS). [ Time Frame: baseline and 16 weeks ]
    The AUASS score range is 1-7 (mild), 8-19 (moderate) and 20-35 (severe). The AUASS asks 7 questions scored 0-5, the scores are summed for the total score.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per HIPAA Authorization for the USA test sites is obtained from subject or legally authorized representative prior to the initiation of this study (including withdrawal of prohibited medication, if applicable)
  2. Subject must be an ambulatory male at least 18 years of age.
  3. Subject has been diagnosed with prostate carcinoma and has elected to undergo external beam radiation therapy.
  4. Subject is willing to complete the American Urology Association Symptom Score (AUASS) Questionnaire.

Exclusion Criteria:

  1. Subject has undergone a prostatectomy
  2. Subject exhibits symptoms of urinary tract infection.
  3. Subject exhibits severe neurologic damage or has undergone prostatectomy.
  4. Subject diagnosed with OAB and is being treated with medication for alleviation of OAB symptoms within 12 months prior to the Screening Visit.
  5. Subject has evidence of uncontrolled narrow angle glaucoma, urinary or gastric retention, neurogenic bladder; prostatitis, or persistent UTI.
  6. Subject exhibits hypersensitivity to Solifenacin succinate, any ingredients, or other anticholinergic agents.
  7. Subject has undergone treatment with any investigational drug within 30 days prior to screening procedure.
  8. Subject has exhibited history of diagnosed gastrointestinal obstructive disease.
  9. Subjects with co-morbid lower urinary tract symptoms (LUTS).
  10. Subjects exhibiting clinically significant bladder outflow obstruction (BOO).
  11. In the opinion of the Study Investigator, the patient has exhibited prior to the screening or Baseline visit, a clinically significant disease or medical condition that would exclude the subject from participating in the study.
  12. Subjects who have received prior pelvic radiation.
  13. Subjects with history of severe hepatic impairment.
  14. Subjects with history of Congenital or Acquired QT prolongation.
Contacts and Locations
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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): NCT01777217


Locations
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United States, Texas
Century Cancer Center
Houston, Texas, United States, 77025
Sponsors and Collaborators
Advanced Research Network
Astellas Pharma US, Inc.
Investigators
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Principal Investigator: Sanjay Mehta, M.D. Century Cancer Centers
More Information
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Publications:

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Responsible Party: Advanced Research Network
ClinicalTrials.gov Identifier: NCT01777217    
Other Study ID Numbers: VESI-12J03
First Posted: January 28, 2013    Key Record Dates
Results First Posted: January 16, 2015
Last Update Posted: January 16, 2015
Last Verified: December 2014
Keywords provided by Advanced Research Network:
Urination Disorder
Overactive Bladder
Prostate Cancer Radiation
Vesicare
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Solifenacin Succinate
Muscarinic Antagonists
 Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents