Trial Outcomes & Findings for Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR) (NCT NCT00431041)
NCT ID: NCT00431041
Last Updated: 2010-06-08
Results Overview
The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit
COMPLETED
PHASE4
132 participants
8 weeks
2010-06-08
Participant Flow
Participant milestones
| Measure |
Solifenacin
Solifenacin succinate: 5 mg tablets, taken orally, once daily
|
Oxybutynin IR
Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
64
|
|
Overall Study
COMPLETED
|
52
|
40
|
|
Overall Study
NOT COMPLETED
|
16
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)
Baseline characteristics by cohort
| Measure |
Solifenacin
n=68 Participants
Solifenacin succinate: 5 mg tablets, taken orally, once daily
|
Oxybutynin IR
n=64 Participants
Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=65 years
|
41 participants
n=5 Participants
|
34 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Age, Customized
>65 years
|
27 participants
n=5 Participants
|
30 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
62 participants
n=5 Participants
|
57 participants
n=7 Participants
|
119 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Aboriginal
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Data represents ITT Population: all randomized subjects
The number of subjects reporting incidence of dry mouth as an adverse event (AE) following direct questioning at each patient follow-up visit
Outcome measures
| Measure |
Solifenacin
n=68 Participants
Solifenacin succinate: 5 mg tablets, taken orally, once daily
|
Oxybutynin IR
n=64 Participants
Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
|
|---|---|---|
|
The Number of Subjects Reporting Incidence of Dry Mouth as an Adverse Event
|
24 participants
|
53 participants
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: Data represents ITT Population: all randomized subjects
The number of subjects reporting dry mouth at each severity level when dry mouth was reported as an Adverse Event (AE). Dry mouth severity was categorized as "mild" (relieved with fluid/hard candy), "moderate" (dry mouth and throat with no difficulty swallowing solid food/water) \& "severe" (very dry mouth \& throat, difficulty swallowing solid food without water)
Outcome measures
| Measure |
Solifenacin
n=68 Participants
Solifenacin succinate: 5 mg tablets, taken orally, once daily
|
Oxybutynin IR
n=64 Participants
Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
|
|---|---|---|
|
The Severity of Dry Mouth Reported as an Adverse Event
Mild
|
18 participants
|
16 participants
|
|
The Severity of Dry Mouth Reported as an Adverse Event
Moderate
|
3 participants
|
22 participants
|
|
The Severity of Dry Mouth Reported as an Adverse Event
Severe
|
3 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Baseline and 8 WeeksPopulation: Data represents ITT Population: all randomized subjects. The numbers of subjects for each time point are noted in the category titles. Data for week 8 and Change from Baseline to week 8 includes all subjects who completed the study
Subjects were instructed to complete the diary in the 3 day period immediately proceding the visit. Subjects recorded each micturition or instance of passing urine in the toliet. The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from baseline was calculated as Week 8- Baseline.
Outcome measures
| Measure |
Solifenacin
n=68 Participants
Solifenacin succinate: 5 mg tablets, taken orally, once daily
|
Oxybutynin IR
n=64 Participants
Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
|
|---|---|---|
|
Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary
Change in micturition frequency at 8 wks(N=52; 40)
|
-2.3 Micturitions per day
Standard Deviation 3.3
|
-3.1 Micturitions per day
Standard Deviation 2.7
|
|
Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary
Micturition frequency at Baseline (N=68; 64)
|
12.4 Micturitions per day
Standard Deviation 3.2
|
12.5 Micturitions per day
Standard Deviation 3.1
|
|
Change From Baseline in Micturition Frequency as Reported in Subject 3-day Diary
Micturition frequency at 8 weeks (N=52; 40)
|
9.9 Micturitions per day
Standard Deviation 3.7
|
9.0 Micturitions per day
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline and 8 weeksPopulation: Data represents ITT Population: all randomized subjects. The numbers of subjects for each time point are noted in the category titles. Data for week 8 and Change from Baseline to week 8 includes all subjects who completed the study
Subjects were instructed to complete the diary in the 3 day period immediately preceding the visit. Subjects recorded each urgency episode or instance of strong desire to pass urine. The mean was calculated for each time point as the average of the day 1-3 measurements from the associated 3 day diary. Change from Baseline was calculated as Week 8- Baseline.
Outcome measures
| Measure |
Solifenacin
n=68 Participants
Solifenacin succinate: 5 mg tablets, taken orally, once daily
|
Oxybutynin IR
n=64 Participants
Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
|
|---|---|---|
|
Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary
Change in urgency episodes at 8 weeks (N=52; 40)
|
-2.65 urgency episodes per day
Standard Deviation 4.54
|
-3.70 urgency episodes per day
Standard Deviation 3.26
|
|
Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary
Urgency episodes at Baseline (N= 68; 64)
|
6.3 urgency episodes per day
Standard Deviation 3.98
|
6.6 urgency episodes per day
Standard Deviation 4.43
|
|
Change From Baseline in Urgency Episodes as Reported in Subject 3-day Diary
Urgency episodes at 8 weeks (N=52; 40)
|
3.8 urgency episodes per day
Standard Deviation 5.04
|
2.1 urgency episodes per day
Standard Deviation 2.88
|
Adverse Events
Solifenacin
Oxybutynin IR
Serious adverse events
| Measure |
Solifenacin
n=68 participants at risk
Solifenacin succinate: 5 mg tablets, taken orally, once daily
|
Oxybutynin IR
n=64 participants at risk
Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
|
|---|---|---|
|
Injury, poisoning and procedural complications
fracture, right foot
|
1.5%
1/68 • Number of events 1
|
0.00%
0/64
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervical adenocarcinoma in situ
|
1.5%
1/68 • Number of events 1
|
0.00%
0/64
|
|
Psychiatric disorders
Worsening depression
|
1.5%
1/68 • Number of events 1
|
0.00%
0/64
|
Other adverse events
| Measure |
Solifenacin
n=68 participants at risk
Solifenacin succinate: 5 mg tablets, taken orally, once daily
|
Oxybutynin IR
n=64 participants at risk
Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
|
|---|---|---|
|
Eye disorders
Dry Eye
|
0.00%
0/68
|
4.7%
3/64 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
13.2%
9/68 • Number of events 10
|
6.2%
4/64 • Number of events 4
|
|
Gastrointestinal disorders
Dry Mouth
|
35.3%
24/68 • Number of events 25
|
82.8%
53/64 • Number of events 56
|
|
Gastrointestinal disorders
Dysphagia
|
1.5%
1/68 • Number of events 1
|
7.8%
5/64 • Number of events 5
|
|
General disorders
Fatigue
|
5.9%
4/68 • Number of events 4
|
9.4%
6/64 • Number of events 6
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/68
|
4.7%
3/64 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
4.4%
3/68 • Number of events 5
|
4.7%
3/64 • Number of events 3
|
|
Nervous system disorders
Dizziness
|
2.9%
2/68 • Number of events 2
|
9.4%
6/64 • Number of events 6
|
|
Nervous system disorders
Headache
|
2.9%
2/68 • Number of events 2
|
6.2%
4/64 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/68 • Number of events 1
|
4.7%
3/64 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/68
|
4.7%
3/64 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/68
|
7.8%
5/64 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/68
|
14.1%
9/64 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/68
|
4.7%
3/64 • Number of events 3
|
|
Nervous system disorders
Somnolence
|
1.5%
1/68 • Number of events 1
|
4.7%
3/64 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs may not present or publish data prior to publication of the multicenter data or 12 months have elapsed following database lock. Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of up to 90 days from the time submitted to the sponsor for review. PIs may not engage in contacts with the media related to the study, study interventions or data without prior written consent.
- Publication restrictions are in place
Restriction type: OTHER