Trial Outcomes & Findings for Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly (URGE) (NCT NCT01786967)
NCT ID: NCT01786967
Last Updated: 2020-03-18
Results Overview
Treatment Success (Yes/No) was defined by the Treatment Benefit Scale (TBS). TBS is a 4-point scale which was dichotomized into Yes/No for the Treatment Success outcome. The scale asks participants to rate "My condition has been improved: 1= greatly improved, 2=improved, 3=not changed, 4= worsened." If a participant responded 1 (greatly improved) or 2 (improved), they were considered as a "Yes" for Treatment Success. If a participant responded 3 (not changed) or 4 (worsened), then they were considered as a "No" for Treatment Success.
COMPLETED
PHASE3
61 participants
4 weeks
2020-03-18
Participant Flow
Participant milestones
| Measure |
Fesoterodine Fumarate
Participants will receive 4 mg of study drug for first 2 weeks, and then 8 mg of study drugs for 2 weeks.
Fesoterodine Fumarate: FDA approved anticholinergic medication used for treatment of urge urinary incontinence
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
Extensive Metabolizers
|
54
|
|
Overall Study
Poor Metabolizers
|
4
|
|
Overall Study
Metabolizer Status Undetermined
|
3
|
|
Overall Study
COMPLETED
|
61
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly (URGE)
Baseline characteristics by cohort
| Measure |
Fesoterodine Fumarate
n=61 Participants
Women aged 50 and older received 4mg of fesoterodine fumarate for 2 weeks followed by 8mg fesoterodine for 2 weeks.
|
|---|---|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Functional Comorbidity Index Score
|
3 units on a scale
n=5 Participants
|
|
Current smoker
Current smoker-Yes
|
2 Participants
n=5 Participants
|
|
Current smoker
Current smoker-No
|
59 Participants
n=5 Participants
|
|
Katz ADL (Activities of Daily Living) score (total)
|
5 units on a scale
n=5 Participants
|
|
Lawton IADL (Instrumental Activities of Daily Living Scale) score (total)
|
8 units on a scale
n=5 Participants
|
|
Overactive bladder questionnaire - symptom bother
|
68.1 units on a scale
STANDARD_DEVIATION 19.9 • n=5 Participants
|
|
Overactive bladder questionnaire - quality of life
|
48.0 units on a scale
STANDARD_DEVIATION 19.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: Extensive and poor metabolizers are the two cohorts being compared. These cohorts were determined based on their CYP2D6 sequence. Only 58 subjects have data as 3 participants' sequencing did not yield a definitive metabolizer status.
Treatment Success (Yes/No) was defined by the Treatment Benefit Scale (TBS). TBS is a 4-point scale which was dichotomized into Yes/No for the Treatment Success outcome. The scale asks participants to rate "My condition has been improved: 1= greatly improved, 2=improved, 3=not changed, 4= worsened." If a participant responded 1 (greatly improved) or 2 (improved), they were considered as a "Yes" for Treatment Success. If a participant responded 3 (not changed) or 4 (worsened), then they were considered as a "No" for Treatment Success.
Outcome measures
| Measure |
Extensive Metabolizers
n=54 Participants
Extensive metabolizer status was based on CYP2D6 sequence
|
Poor Metabolizers
n=4 Participants
Poor metabolizer status was based on CYP2D6 sequence
|
|---|---|---|
|
Percentage With Treatment Success
|
74.1 percentage of participants
|
75.0 percentage of participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Extensive and poor metabolizers are the two cohorts being compared. These cohorts were determined based on their CYP2D6 sequence. Only 58 subjects have data as 3 participants' sequencing did not yield a definitive metabolizer status.
Outcome was defined as moderate to severe anticipated adverse events (AE) based on the NCI Common Terminology Criteria for Adverse Events (CTCAE). Each AE is graded 1-5 with Grade 1=mild AE, Grade 2=moderate AE, Grade 3=severe AE, Grade 4=life-threatening or disabling AE, grade 5=Death-related to AE. Any side effect grade \>= 2 considered a moderate to severe AE. Anticipated AEs included dizziness, somnolence, insomnia, confusion, cognitive impairment, dry eyes, blurry vision, dry mouth, constipation, nausea, dyspepsia and urinary retention. Example: dry mouth grades per CTCAE: Grade 1=symptomatic without significant dietary alteration; unstimulated saliva flow \> 0.2 mL/min; Grade 2=symptomatic and significant oral intake alteration; unstimulated saliva flow 0.1 to 0.2 mL/min; Grade 3=symptoms leading to inability to adequately aliment orally; IV fluids, tube feedings or total parenteral nutrition indicated; unstimulated saliva \< 0.1 mL/min.
Outcome measures
| Measure |
Extensive Metabolizers
n=54 Participants
Extensive metabolizer status was based on CYP2D6 sequence
|
Poor Metabolizers
n=4 Participants
Poor metabolizer status was based on CYP2D6 sequence
|
|---|---|---|
|
Percentage With Moderate to Severe Anticipated Drug Associated Adverse Events
|
14.8 percentage of participants
|
0.0 percentage of participants
|
Adverse Events
Extensive Metabolizers
Poor Metabolizers
Metabolizer Status Undetermined
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Extensive Metabolizers
n=54 participants at risk
Extensive metabolizer status was based on CYP2D6 sequence
|
Poor Metabolizers
n=4 participants at risk
Poor metabolizer status was based on CYP2D6 sequence
|
Metabolizer Status Undetermined
n=3 participants at risk
Metabolizer status was not able to be determined
|
|---|---|---|---|
|
Eye disorders
Anticholinergic adverse events
|
9.3%
5/54 • Number of events 5 • 4 weeks
|
0.00%
0/4 • 4 weeks
|
0.00%
0/3 • 4 weeks
|
Additional Information
Jennifer Wu, MD, MPH
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place