Trial Outcomes & Findings for A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107) (NCT NCT00768521)
NCT ID: NCT00768521
Last Updated: 2018-02-22
Results Overview
Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data)
COMPLETED
PHASE1
20 participants
4 hours post dose 7
2018-02-22
Participant Flow
First Patient Entered: 8 Sep 2008 Last Patient, Last Visit: 19 Jan 2009 2 sites Since Part I of the study enrolled sufficiently there was no need to modify the study design nor conduct Part II.
Patients completed a 1-week screening and 1-week placebo run-in period. Patients were randomized Visit 3/Day 1. Patients were excluded if they were unable to adequately complete a diary, number of micturitions was ≤ 8, or number of urge incontinence was ≤ 1 on each diary day.
Participant milestones
| Measure |
Tolterodine Then Placebo
Tolterodine 4 mg then Placebo
|
Placebo Then Tolterodine
Placebo then Tolterodine 4 mg
|
|---|---|---|
|
Period 1
STARTED
|
9
|
11
|
|
Period 1
COMPLETED
|
9
|
11
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
9
|
11
|
|
Period 2
COMPLETED
|
9
|
11
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
Baseline characteristics by cohort
| Measure |
All Participants
n=20 Participants
All Study Participants from all groups.
|
|---|---|
|
Age, Continuous
|
59.1 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 4 hours post dose 7Population: All patients
Change from baseline in maximum cystometric capacity at 4 hours post dose 7 on tolterodine 4 mg and placebo (analysis on natural log transformed data)
Outcome measures
| Measure |
Tolterodine
n=20 Participants
Tolterodine 4 mg
|
Placebo
n=20 Participants
|
|---|---|---|
|
Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 7 on Tolterodine 4 mg and Placebo
|
1.15 Percentage change
90% Confidence Interval 0.06 • Interval 1.04 to 1.28
|
0.94 Percentage change
90% Confidence Interval 0.06 • Interval 0.84 to 1.04
|
SECONDARY outcome
Timeframe: 4 hours post dose 1Population: All patients
Change from baseline in maximum cystometric capacity at 4 hours post dose 1 on tolterodine 4 mg and placebo (analysis on natural log transformed data)
Outcome measures
| Measure |
Tolterodine
n=20 Participants
Tolterodine 4 mg
|
Placebo
n=20 Participants
|
|---|---|---|
|
Change From Baseline in Maximum Cystometric Capacity at 4 Hours Post Dose 1 on Tolterodine 4 mg and Placebo
|
0.92 Percentage change
90% Confidence Interval 0.06 • Interval 0.83 to 1.02
|
0.91 Percentage change
90% Confidence Interval 0.06 • Interval 0.82 to 1.0
|
Adverse Events
Tolterodine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tolterodine
n=20 participants at risk
Tolterodine 4 mg
|
Placebo
n=20 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • The adverse experiences reporting are from the randomization visit to follow-up phone call.
Urinalysis and vital sign measurements were performed to monitor safety at clinic visits. Patients were also, queried for any adverse experiences at each visit.
|
0.00%
0/20 • The adverse experiences reporting are from the randomization visit to follow-up phone call.
Urinalysis and vital sign measurements were performed to monitor safety at clinic visits. Patients were also, queried for any adverse experiences at each visit.
|
|
Gastrointestinal disorders
Dry Mouth
|
5.0%
1/20 • The adverse experiences reporting are from the randomization visit to follow-up phone call.
Urinalysis and vital sign measurements were performed to monitor safety at clinic visits. Patients were also, queried for any adverse experiences at each visit.
|
0.00%
0/20 • The adverse experiences reporting are from the randomization visit to follow-up phone call.
Urinalysis and vital sign measurements were performed to monitor safety at clinic visits. Patients were also, queried for any adverse experiences at each visit.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/20 • The adverse experiences reporting are from the randomization visit to follow-up phone call.
Urinalysis and vital sign measurements were performed to monitor safety at clinic visits. Patients were also, queried for any adverse experiences at each visit.
|
5.0%
1/20 • The adverse experiences reporting are from the randomization visit to follow-up phone call.
Urinalysis and vital sign measurements were performed to monitor safety at clinic visits. Patients were also, queried for any adverse experiences at each visit.
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20 • The adverse experiences reporting are from the randomization visit to follow-up phone call.
Urinalysis and vital sign measurements were performed to monitor safety at clinic visits. Patients were also, queried for any adverse experiences at each visit.
|
0.00%
0/20 • The adverse experiences reporting are from the randomization visit to follow-up phone call.
Urinalysis and vital sign measurements were performed to monitor safety at clinic visits. Patients were also, queried for any adverse experiences at each visit.
|
Additional Information
Executive Vice President, Clinical and Quantitative Sciences
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER