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

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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 Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Over-Active Bladder
Interventions: Drug: Solifenacin succinate
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Solifenacin Succinate

Solifenacin succinate, 5mg or 10 mg once daily

Solifenacin succinate

Placebo

Drug: Placebo oral

Placebo


Participant Flow:   Overall Study
    Solifenacin Succinate   Placebo
STARTED   4   4 
COMPLETED   4   4 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Solifenacin Succinate

Solifenacin succinate, 5mg or 10 mg once daily

Solifenacin succinate

Placebo

Drug: Placebo oral

Placebo

Total Total of all reporting groups

Baseline Measures
   Solifenacin Succinate   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   4   8 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.5  (8.74)   66  (7.57)   65.25  (7.61) 
Age [1] 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   2   1   3 
>=65 years   2   3   5 
[1] Participant population is >=50
Gender [1] 
[Units: Participants]
     
Female   0   0   0 
Male   4   4   8 
[1] The participant population are all males
Region of Enrollment 
[Units: Participants]
     
United States   4   4   8 


  Outcome Measures

1.  Primary:   Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).   [ Time Frame: baseline and 16 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Early termination leading to small numbers of subjects analyzed.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Sanjay Mehta
Organization: Century Cancer Centers
phone: 713-631-8181


Publications:


Responsible Party: Advanced Research Network
ClinicalTrials.gov Identifier: NCT01777217     History of Changes
Other Study ID Numbers: VESI-12J03
First Submitted: January 24, 2013
First Posted: January 28, 2013
Results First Submitted: October 10, 2014
Results First Posted: January 16, 2015
Last Update Posted: January 16, 2015