Trial Outcomes & Findings for Trospium Chloride XR in Obese Female Patients With Overactive Bladder (NCT NCT00932022)

Results Overview

Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

127 participants

Primary outcome timeframe

Baseline (Week 2), Week 14

Results posted on

2013-01-21

Participant Flow

Participant milestones

Participant milestones
Measure	Trospium Chloride XR 60 mg Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.	Placebo Placebo capsule taken orally once daily for 14 weeks.
Overall Study STARTED	64	63
Overall Study COMPLETED	59	59
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trospium Chloride XR in Obese Female Patients With Overactive Bladder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trospium Chloride XR 60 mg n=64 Participants Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.	Placebo n=63 Participants Placebo capsule taken orally once daily for 14 weeks.	Total n=127 Participants Total of all reporting groups
Age, Customized <18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Customized 18 to 75 years	64 Participants n=5 Participants	63 Participants n=7 Participants	127 Participants n=5 Participants
Age, Customized >75 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	63 Participants n=7 Participants	127 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Week 2), Week 14

Population: Modified Intent-to-Treat (mITT) defined as all patients who were randomized and received at least one dose of study medication. Analysis below was done on patients from the mITT population who completed the study at Week 14 and who had data available for this outcome measure.

Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement.

Outcome measures

Outcome measures
Measure	Trospium Chloride XR 60 mg n=54 Participants Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.	Placebo n=49 Participants Placebo capsule taken orally once daily for 14 weeks.
Percent Change From Baseline in Urinary Urgency Incontinence (UUI)	-23.7 Percent change Standard Deviation 36.16 • Interval -88.9 to 50.0	57.8 Percent change Standard Deviation 275.3 • Interval -73.7 to 1400.0

SECONDARY outcome

Timeframe: Baseline (Week 2), Week 14

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Trospium Chloride XR 60 mg n=64 participants at risk Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.	Placebo n=63 participants at risk Placebo capsule taken orally once daily for 14 weeks.
Cardiac disorders Atrial fibrillation	0.00% 0/64 The safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.	1.6% 1/63 The safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.

Other adverse events

Other adverse events
Measure	Trospium Chloride XR 60 mg n=64 participants at risk Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.	Placebo n=63 participants at risk Placebo capsule taken orally once daily for 14 weeks.
General disorders Dry mouth	9.4% 6/64 The safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.	4.8% 3/63 The safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER