Trial Outcomes & Findings for A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo (NCT NCT00350636)
NCT ID: NCT00350636
Last Updated: 2010-05-10
Results Overview
Average number of daily incontinence episodes at baseline
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
789 participants
Primary outcome timeframe
Baseline
Results posted on
2010-05-10
Participant Flow
Participant milestones
| Measure |
Oxybutynin Topical Gel
1 g Oxybutynin topical gel
|
Placebo Topical Gel
1 g placebo topical gel
|
|---|---|---|
|
Overall Study
STARTED
|
389
|
400
|
|
Overall Study
COMPLETED
|
346
|
355
|
|
Overall Study
NOT COMPLETED
|
43
|
45
|
Reasons for withdrawal
| Measure |
Oxybutynin Topical Gel
1 g Oxybutynin topical gel
|
Placebo Topical Gel
1 g placebo topical gel
|
|---|---|---|
|
Overall Study
Adverse Event
|
19
|
13
|
|
Overall Study
Protocol Violation
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
13
|
17
|
|
Overall Study
Lost to Follow-up
|
9
|
8
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Other
|
1
|
2
|
Baseline Characteristics
A Comparison of a New Drug to Treat Overactive Bladder vs. Placebo
Baseline characteristics by cohort
| Measure |
Oxybutynin Topical Gel
n=389 Participants
1 g Oxybutynin topical gel
|
Placebo Topical Gel
n=400 Participants
1 g placebo topical gel
|
Total
n=789 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
246 Participants
n=5 Participants
|
260 Participants
n=7 Participants
|
506 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
143 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
283 Participants
n=5 Participants
|
|
Age Continuous
|
59.5 years
STANDARD_DEVIATION 12.50 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 12.17 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 12.17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
352 Participants
n=5 Participants
|
352 Participants
n=7 Participants
|
704 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
389 participants
n=5 Participants
|
400 participants
n=7 Participants
|
789 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineAverage number of daily incontinence episodes at baseline
Outcome measures
| Measure |
Oxybutynin Topical Gel
n=389 Participants
1 g Oxybutynin topical gel
|
Placebo Topical Gel
n=400 Participants
1 g placebo topical gel
|
|---|---|---|
|
Baseline Average Number of Daily Incontinence Episodes
|
5.4 Number of episodes
Standard Deviation 3.26
|
5.4 Number of episodes
Standard Deviation 3.28
|
PRIMARY outcome
Timeframe: Baseline to Week 12Change from Baseline to Week 12 in average daily number of incontinence episodes
Outcome measures
| Measure |
Oxybutynin Topical Gel
n=389 Participants
1 g Oxybutynin topical gel
|
Placebo Topical Gel
n=400 Participants
1 g placebo topical gel
|
|---|---|---|
|
Change From Baseline in Average Daily Number of Incontinence Episodes
|
-3.0 Number of episodes
Standard Deviation 2.73
|
-2.5 Number of episodes
Standard Deviation 3.06
|
SECONDARY outcome
Timeframe: BaselineNumber of daily urinary voids
Outcome measures
| Measure |
Oxybutynin Topical Gel
n=389 Participants
1 g Oxybutynin topical gel
|
Placebo Topical Gel
n=400 Participants
1 g placebo topical gel
|
|---|---|---|
|
Baseline Average Daily Urinary Frequency
|
12.4 Number of urinary episodes
Standard Deviation 3.34
|
12.2 Number of urinary episodes
Standard Deviation 3.32
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksChange from baseline in average daily urinary frequency
Outcome measures
| Measure |
Oxybutynin Topical Gel
n=389 Participants
1 g Oxybutynin topical gel
|
Placebo Topical Gel
n=400 Participants
1 g placebo topical gel
|
|---|---|---|
|
Change From Baseline in Average Daily Urinary Frequency
|
-2.7 Number of urinary episodes
Standard Deviation 3.21
|
-2.0 Number of urinary episodes
Standard Deviation 2.82
|
SECONDARY outcome
Timeframe: BaselineBaseline average urine void volume
Outcome measures
| Measure |
Oxybutynin Topical Gel
n=389 Participants
1 g Oxybutynin topical gel
|
Placebo Topical Gel
n=400 Participants
1 g placebo topical gel
|
|---|---|---|
|
Baseline Average Urine Void Volume
|
163.4 mL
Standard Deviation 65.85
|
167.9 mL
Standard Deviation 68.40
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 12Change from baseline to Week 12 in average urine void volume
Outcome measures
| Measure |
Oxybutynin Topical Gel
n=389 Participants
1 g Oxybutynin topical gel
|
Placebo Topical Gel
n=400 Participants
1 g placebo topical gel
|
|---|---|---|
|
Change From Baseline in Average Urine Void Volume
|
21.0 mL
Standard Deviation 65.33
|
3.8 mL
Standard Deviation 53.79
|
Adverse Events
Oxybutynin Topical Gel
Serious events: 7 serious events
Other events: 176 other events
Deaths: 0 deaths
Placebo Topical Gel
Serious events: 10 serious events
Other events: 145 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Oxybutynin Topical Gel
n=389 participants at risk
1 g Oxybutynin topical gel
|
Placebo Topical Gel
n=400 participants at risk
1 g placebo topical gel
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/389 • 12 weeks
|
0.25%
1/400 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.26%
1/389 • Number of events 1 • 12 weeks
|
0.25%
1/400 • Number of events 1 • 12 weeks
|
|
Nervous system disorders
Cerebral infarction
|
0.26%
1/389 • Number of events 1 • 12 weeks
|
0.00%
0/400 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/389 • 12 weeks
|
0.25%
1/400 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/389 • 12 weeks
|
0.25%
1/400 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/389 • 12 weeks
|
0.25%
1/400 • Number of events 1 • 12 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/389 • 12 weeks
|
0.25%
1/400 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/389 • 12 weeks
|
0.25%
1/400 • Number of events 1 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.26%
1/389 • Number of events 1 • 12 weeks
|
0.00%
0/400 • 12 weeks
|
|
General disorders
Non-cardiac chest pain
|
0.26%
1/389 • Number of events 1 • 12 weeks
|
0.00%
0/400 • 12 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/389 • 12 weeks
|
0.25%
1/400 • Number of events 1 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.26%
1/389 • Number of events 1 • 12 weeks
|
0.00%
0/400 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.26%
1/389 • Number of events 1 • 12 weeks
|
0.00%
0/400 • 12 weeks
|
|
Infections and infestations
Pneumonia
|
0.26%
1/389 • Number of events 1 • 12 weeks
|
0.00%
0/400 • 12 weeks
|
|
Renal and urinary disorders
Renal hemmorrhage
|
0.00%
0/389 • 12 weeks
|
0.25%
1/400 • Number of events 1 • 12 weeks
|
|
Infections and infestations
Urosepsis
|
0.00%
0/389 • 12 weeks
|
0.25%
1/400 • Number of events 1 • 12 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/389 • 12 weeks
|
0.25%
1/400 • Number of events 1 • 12 weeks
|
Other adverse events
| Measure |
Oxybutynin Topical Gel
n=389 participants at risk
1 g Oxybutynin topical gel
|
Placebo Topical Gel
n=400 participants at risk
1 g placebo topical gel
|
|---|---|---|
|
General disorders
Application site pruritis
|
2.1%
8/389 • Number of events 10 • 12 weeks
|
0.75%
3/400 • Number of events 3 • 12 weeks
|
|
Infections and infestations
Bronchitis
|
2.3%
9/389 • Number of events 9 • 12 weeks
|
2.2%
9/400 • Number of events 11 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
1.8%
7/389 • Number of events 7 • 12 weeks
|
2.0%
8/400 • Number of events 9 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
2.3%
9/389 • Number of events 11 • 12 weeks
|
3.2%
13/400 • Number of events 13 • 12 weeks
|
|
Nervous system disorders
Dizziness
|
2.8%
11/389 • Number of events 12 • 12 weeks
|
1.0%
4/400 • Number of events 4 • 12 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
7.5%
29/389 • Number of events 29 • 12 weeks
|
2.8%
11/400 • Number of events 12 • 12 weeks
|
|
General disorders
Fatigue
|
2.1%
8/389 • Number of events 8 • 12 weeks
|
1.0%
4/400 • Number of events 4 • 12 weeks
|
|
Gastrointestinal disorders
Gastroenteritis viral
|
2.1%
8/389 • Number of events 8 • 12 weeks
|
1.5%
6/400 • Number of events 6 • 12 weeks
|
|
Nervous system disorders
Headache
|
4.9%
19/389 • Number of events 24 • 12 weeks
|
5.8%
23/400 • Number of events 28 • 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
11/389 • Number of events 11 • 12 weeks
|
2.2%
9/400 • Number of events 10 • 12 weeks
|
|
Infections and infestations
Sinusitis
|
2.3%
9/389 • Number of events 10 • 12 weeks
|
4.5%
18/400 • Number of events 20 • 12 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
21/389 • Number of events 21 • 12 weeks
|
5.0%
20/400 • Number of events 20 • 12 weeks
|
|
Infections and infestations
Urinary tract infection
|
6.9%
27/389 • Number of events 29 • 12 weeks
|
4.2%
17/400 • Number of events 17 • 12 weeks
|
Additional Information
Gary Hoel, PhD, Executive Director
Watson Laboratories, Inc
Phone: 801-808-8866
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60