Urinary Bladder, OveractivePhase 3NCT00646880
A Study to Evaluate the Efficacy of Tolterodine Prolonged Release Compared With Propiverine for the Treatment of Korean Patients With Overactive Bladder as Assessed by Ambulatory Urodynamic Monitoring
A Phase 3 study testing propiverine and tolterodine PR in people with Urinary Bladder, Overactive, run by Pfizer at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the difference between tolterodine prolonged release (PR) and propiverine in efficacy as assessed by the AUM and to show that tolterodine PR is similar to propiverine with respect to micturition chart variables and safety profile. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- propiverine and tolterodine PR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2003to Aug 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of urinary urgency
- Symptoms of urinary frequency (greater than or equal to 8 micturitions per 24 hours) as verified on the patient's micturition chart
- Symptoms of overactive bladder for greater than or equal to 6 months
Who cannot join
- Stress incontinence as determined by the investigator and confirmed for female patients by a cough provocation test
- An average volume voided of >200 ml per micturition as verified on the micturition chart before randomization
- Total daily urine volume of >3000 ml as verified on the micturition chart before randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-Blind Crossover Comparative Ambulatory Urodynamic Monitoring (AUM) Study of Tolterodine PR and Propiverine in Korean Patients With Overactive Bladder (OAB)
The purpose of this study is to compare the difference between tolterodine prolonged release (PR) and propiverine in efficacy as assessed by the AUM and to show that tolterodine PR is similar to propiverine with respect to micturition chart variables and safety profile.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- propiverine, tolterodine PR
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propiverineDrug
Two week washout period followed by propiverine 20 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to tolterodine PR 4 mg capsule daily for 1 week.
tolterodine PRDrug
Two week washout period followed by tolterodine PR 4 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to propiverine 20 mg capsule daily for 1 week.
| Study group | Role | What they receive |
|---|---|---|
| Propiverine/tolterodine group | Active comparator | Not described Receives: Drug: propiverine |
| Tolerodine/propiverine group | Active comparator | Not described Receives: Drug: tolterodine PR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameters of detrusor activity, occurring throughout the duration of comparable AUM
Measured: 28 days
Secondary outcomes (9)
Number of pads used per 24 hours
Measured: 28 days
Urge Incontinence
Measured: 28 days
Number of urgency episodes
Measured: 28 days
Number of micturitions per 24 hours
Measured: 28 days
Volume voided per micturition
Measured: 28 days
Patient's perception of bladder condition
Measured: 28 days
Patient's perception of treatment benefit
Measured: 28 days
Patient's perception of urgency
Measured: 28 days
The occurrences of adverse events and withdrawals and changes in laboratory variables over each 1-week treatment period.
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startMar 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646880
- Sponsor's protocol ID
- DETAOD-0084-055
- Status last verified
- Mar 2008
- First submitted
- 26 Mar 2008
- Last updated
- 31 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Crossover Comparative Ambulatory Urodynamic Monitoring (AUM) Study of Tolterodine PR and Propiverine in Korean Patients With Overactive Bladder (OAB)
- ClinicalTrials.gov ID
- NCT00646880
- Acronym / sponsor ID
- DETAOD-0084-055
- Conditions
- Urinary Bladder, Overactive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Study completion
- Aug 2003 (actual)
- First posted
- 31 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the difference between tolterodine prolonged release (PR) and propiverine in efficacy as assessed by the AUM and to show that tolterodine PR is similar to propiverine with respect to micturition chart variables and safety profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propiverine/tolterodine group | Active comparator | Drug: propiverine |
| Tolerodine/propiverine group | Active comparator | Drug: tolterodine PR |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptoms of urinary urgency
- Symptoms of urinary frequency (greater than or equal to 8 micturitions per 24 hours) as verified on the patient's micturition chart
- Symptoms of overactive bladder for greater than or equal to 6 months
Key exclusion criteria (3 listed)
- Stress incontinence as determined by the investigator and confirmed for female patients by a cough provocation test
- An average volume voided of >200 ml per micturition as verified on the micturition chart before randomization
- Total daily urine volume of >3000 ml as verified on the micturition chart before randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propiverineTwo week washout period followed by propiverine 20 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to tolterodine PR 4 mg capsule daily for 1 week. | Drug | Propiverine/tolterodine group |
| tolterodine PRTwo week washout period followed by tolterodine PR 4 mg capsule daily for 1 week, followed by a second 2-week washout; patients were then crossed over to propiverine 20 mg capsule daily for 1 week. | Drug | Tolerodine/propiverine group |
Primary outcome
Parameters of detrusor activity, occurring throughout the duration of comparable AUM
Time frame: 28 days
9 secondary outcomes
Number of pads used per 24 hours
Time frame: 28 days
Urge Incontinence
Time frame: 28 days
Number of urgency episodes
Time frame: 28 days
Number of micturitions per 24 hours
Time frame: 28 days
Volume voided per micturition
Time frame: 28 days
Patient's perception of bladder condition
Time frame: 28 days
Patient's perception of treatment benefit
Time frame: 28 days
Patient's perception of urgency
Time frame: 28 days
The occurrences of adverse events and withdrawals and changes in laboratory variables over each 1-week treatment period.
Time frame: 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2008.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing propiverine and tolterodine PR in people with Urinary Bladder, Overactive, run by Pfizer at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parameters of detrusor activity, occurring throughout the duration of comparable AUM (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2008.