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

This study is currently recruiting participants.
Verified March 2013 by Advanced Research Network
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
Advanced Research Network
ClinicalTrials.gov Identifier:
NCT01777217
First received: January 24, 2013
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Over-Active Bladder
Drug: Solifenacin succinate
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Advanced Research Network:

Primary Outcome Measures:
  • Change from baseline to end of study measured by the American Urology Association Symptom Score Questionnaire (AUASS). [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: solifenacin succinate
Solifenacin succinate, 5mg or 10 mg once daily
Drug: Solifenacin succinate
Other Name: VESIcare
Placebo Comparator: Placebo
Drug: Placebo oral
Drug: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777217

Contacts
Contact: Rima King, BS, CCRP 832-681-8740 rking@advancedresearchnetwork.com

Locations
United States, Colorado
Century Cancer Center Recruiting
Greenwood Village, Colorado, United States, 80111
Contact: Emily Cruz, RN    720-214-6500      
Sub-Investigator: Barry Blyton, MD         
United States, Texas
Century Cancer Center Recruiting
Houston, Texas, United States, 77025
Contact: Starr Walker    713-630-8181      
Contact: Rokisha Howard    713-630-8181      
Principal Investigator: Sanjay Mehta, MD         
Sponsors and Collaborators
Advanced Research Network
Astellas Pharma US, Inc.
Investigators
Principal Investigator: Sanjay Mehta, M.D. Century Cancer Centers
  More Information

No publications provided

Responsible Party: Advanced Research Network
ClinicalTrials.gov Identifier: NCT01777217     History of Changes
Other Study ID Numbers: VESI-12J03
Study First Received: January 24, 2013
Last Updated: March 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Advanced Research Network:
Urination Disorder
Overactive Bladder
Prostate Cancer Radiation
Vesicare

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014