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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
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Solifenacin Succinate Placebo
Hide Arm/Group Description

Solifenacin succinate, 5mg or 10 mg once daily

Solifenacin succinate

Drug: Placebo oral

Placebo

Period Title: Overall Study
Started 4 4
Completed 4 4
Not Completed 0 0
Arm/Group Title Solifenacin Succinate Placebo Total
Hide Arm/Group Description

Solifenacin succinate, 5mg or 10 mg once daily

Solifenacin succinate

Drug: Placebo oral

Placebo

Total of all reporting groups
Overall Number of Baseline Participants 4 4 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 8 participants
64.5  (8.74) 66  (7.57) 65.25  (7.61)
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  50.0%
1
  25.0%
3
  37.5%
>=65 years
2
  50.0%
3
  75.0%
5
  62.5%
[1]
Measure Description: Participant population is >=50
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 8 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
4
 100.0%
4
 100.0%
8
 100.0%
[1]
Measure Description: The participant population are all males
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 4 participants 8 participants
4 4 8
1.Primary Outcome
Title Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).
Hide Description 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.
Time Frame baseline and 16 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Solifenacin Succinate Placebo
Hide Arm/Group Description:

Solifenacin succinate, 5mg or 10 mg once daily

Solifenacin succinate

Drug: Placebo oral

Placebo

Overall Number of Participants Analyzed 4 4
Median (Standard Deviation)
Unit of Measure: Scores on a scale
9.4  (4.24) 6.7  (4.52)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Solifenacin Succinate Placebo
Hide Arm/Group Description

Solifenacin succinate, 5mg or 10 mg once daily

Solifenacin succinate

Drug: Placebo oral

Placebo

All-Cause Mortality
Solifenacin Succinate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Solifenacin Succinate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Solifenacin Succinate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Early termination leading to small numbers of subjects analyzed.
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