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:
Advanced Research Network
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
- 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)
- Subject must be an ambulatory male at least 18 years of age.
- Subject has been diagnosed with prostate carcinoma and has elected to undergo external beam radiation therapy.
- Subject is willing to complete the American Urology Association Symptom Score (AUASS) Questionnaire.
Exclusion Criteria:
- Subject has undergone a prostatectomy
- Subject exhibits symptoms of urinary tract infection.
- Subject exhibits severe neurologic damage or has undergone prostatectomy.
- Subject diagnosed with OAB and is being treated with medication for alleviation of OAB symptoms within 12 months prior to the Screening Visit.
- Subject has evidence of uncontrolled narrow angle glaucoma, urinary or gastric retention, neurogenic bladder; prostatitis, or persistent UTI.
- Subject exhibits hypersensitivity to Solifenacin succinate, any ingredients, or other anticholinergic agents.
- Subject has undergone treatment with any investigational drug within 30 days prior to screening procedure.
- Subject has exhibited history of diagnosed gastrointestinal obstructive disease.
- Subjects with co-morbid lower urinary tract symptoms (LUTS).
- Subjects exhibiting clinically significant bladder outflow obstruction (BOO).
- 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.
- Subjects who have received prior pelvic radiation.
- Subjects with history of severe hepatic impairment.
- 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 May 22, 2013