Urinary IncontinencePhase 3NCT00293839
Efficacy and Tolerability of DITROPAN XL (Oxybutynin Chloride) Versus DETROL LA (Tolterodine Tartrate) in Treatment of Overactive Bladder
A Phase 3 study testing oxybutynin chloride in people with Urinary Incontinence, run by Alza Corporation, DE, USA.
Trial summary
The purpose of this study is to compare the efficacy of DITROPAN® XL (oxybutynin chloride) Extended-Release Tablets and DETROL® LA (tolterodine tartrate extended-release capsules) in the reduction of urge urinary incontinence episodes during a 12-week treatment period in patients with overactive bladder. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- oxybutynin chloride
- How many people
- 790 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Dec 2002
- 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 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who are able to differentiate urinary incontinence episodes associated with urgency from urinary incontinence episodes not associated with urgency
- during the 7 day baseline period have 21 to 60 urge urinary incontinence (Urge-UI) episodes, a greater number of Urge-UI episodes than urinary incontinence not associated with urge, and an average of 10 or more voids per 24 hours
- are in good general health as determined by medical history, physical examination (general, genital, pelvic, and rectal), laboratory tests and urinalysis
- if taking antihypertension medication, must be on a stable dose
- and if of child-bearing potential, practicing an acceptable method of birth control, and must have a negative pregnancy test at Visit 2 and Visit 3
Who cannot join
- Participants with known, treatable genitourinary conditions (identified on history or on examination) that may cause incontinence (e.g., urinary tract infection, interstitial cystitis, urinary tract obstruction, urethral diverticulum, bladder tumor, bladder stone)
- have given birth or have had pelvic, vaginal or bladder surgery less than 6 months before study enrollment
- with a second post-void residual urine volume > 150 mL at the time of screening (determined by abdominal ultrasound)
- with significant medical problems or other organ abnormality that places them at risk from participating in the study or at a significant risk of developing complete urinary retention
- with significant impairment of the liver or kidneys as determined by laboratory assessments or hematuria (red blood cells in microscopic urinalysis)
About this study
Official title: Comparison of the Efficacy and Tolerability of DITROPAN XL and DETROL LA in the Treatment of Overactive Bladder
The purpose of this study is to compare the efficacy of DITROPAN® XL (oxybutynin chloride) Extended-Release Tablets and DETROL® LA (tolterodine tartrate extended-release capsules) in the reduction of urge urinary incontinence episodes during a 12-week treatment period in patients with overactive bladder. The secondary objective is to compare the tolerability of DITROPAN® XL (oxybutynin chloride) and DETROL® LA (tolterodine tartrate) during a 12-week treatment period.
Read the detailed description
The objective of this study is to compare the efficacy and tolerability of DITROPAN® XL 10 mg once-daily and DETROL® LA 4 mg once-daily in the reduction of urge urinary incontinence episodes in female patients with overactive bladder. This is a multicenter, randomized, double-blind, parallel-group study with two active treatments. Screened patients are qualified for the study based on information obtained from seven consecutive 24-hour urinary diaries completed during the Baseline Week, and other eligibility criteria. Qualifying patients receive 12 weeks of treatment with DITROPAN® XL or DETROL® LA, with clinical visits at the end of Weeks 2, 4, 8, and 12.
Safety evaluations during the study include the collection of adverse events, laboratory tests including blood chemistry and urinalysis, physical examinations, vital signs (blood pressure and heart rate) and post-void residual urine volume. Over-encapsulated DITROPAN® XL, 10 mg tablets once-daily by mouth or over-encapsulated DETROL® LA, 4 mg capsules once daily by mouth. The treatment phase of the study runs for 12 weeks.
- Conditions
- Urinary Incontinence
- Being tested
- oxybutynin chloride
- Keywords
- bladder, overactive
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxybutynin chlorideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of weekly urge urinary incontinence (Urge-UI) episodes at week 12, adjusted for the baseline value
Secondary outcomes (1)
The number of total urinary incontinence (Total-UI) episodes at week 12; Void frequency at week 12; Urge-UI ,Total-UI, and Void frequence at weeks 2, 4, and 8; tolerability of the treatments during the 12-week treatment phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 790 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alza Corporation, DE, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alza Corporation Clinical Trial, Study director, ALZA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293839
- Sponsor's protocol ID
- CR004570
- Status last verified
- Jan 2025
- First submitted
- 16 Feb 2006
- Last updated
- 3 Feb 2025
- Results posted
- No
Publications
Diokno AC, Appell RA, Sand PK, Dmochowski RR, Gburek BM, Klimberg IW, Kell SH; OPERA Study Group. Prospective, randomized, double-blind study of the efficacy and tolerability of the extended-release formulations of oxybutynin and tolterodine for overactive bladder: results of the OPERA trial. Mayo Clin Proc. 2003 Jun;78(6):687-95. doi: 10.4065/78.6.687.
PubMed 12934777
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Tolerability of DITROPAN XL and DETROL LA in the Treatment of Overactive Bladder
- ClinicalTrials.gov ID
- NCT00293839
- Acronym / sponsor ID
- CR004570
- Conditions
- Urinary Incontinence
- Keywords
- bladder, overactive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 790 participants (actual)
- Lead sponsor
- Alza Corporation, DE, USAIndustry (pharma, biotech, devices)
- Study completion
- Dec 2002 (actual)
- First posted
- 20 Feb 2006 (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 efficacy of DITROPAN® XL (oxybutynin chloride) Extended-Release Tablets and DETROL® LA (tolterodine tartrate extended-release capsules) in the reduction of urge urinary incontinence episodes during a 12-week treatment period in patients with overactive bladder. The secondary objective is to compare the tolerability of DITROPAN® XL (oxybutynin chloride) and DETROL® LA (tolterodine tartrate) during a 12-week treatment period.
Detailed description
The objective of this study is to compare the efficacy and tolerability of DITROPAN® XL 10 mg once-daily and DETROL® LA 4 mg once-daily in the reduction of urge urinary incontinence episodes in female patients with overactive bladder. This is a multicenter, randomized, double-blind, parallel-group study with two active treatments. Screened patients are qualified for the study based on information obtained from seven consecutive 24-hour urinary diaries completed during the Baseline Week, and other eligibility criteria. Qualifying patients receive 12 weeks of treatment with DITROPAN® XL or DETROL® LA, with clinical visits at the end of Weeks 2, 4, 8, and 12.
Safety evaluations during the study include the collection of adverse events, laboratory tests including blood chemistry and urinalysis, physical examinations, vital signs (blood pressure and heart rate) and post-void residual urine volume. Over-encapsulated DITROPAN® XL, 10 mg tablets once-daily by mouth or over-encapsulated DETROL® LA, 4 mg capsules once daily by mouth. The treatment phase of the study runs for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants who are able to differentiate urinary incontinence episodes associated with urgency from urinary incontinence episodes not associated with urgency
- during the 7 day baseline period have 21 to 60 urge urinary incontinence (Urge-UI) episodes, a greater number of Urge-UI episodes than urinary incontinence not associated with urge, and an average of 10 or more voids per 24 hours
- are in good general health as determined by medical history, physical examination (general, genital, pelvic, and rectal), laboratory tests and urinalysis
- if taking antihypertension medication, must be on a stable dose
- and if of child-bearing potential, practicing an acceptable method of birth control, and must have a negative pregnancy test at Visit 2 and Visit 3
Key exclusion criteria (5 listed)
- Participants with known, treatable genitourinary conditions (identified on history or on examination) that may cause incontinence (e.g., urinary tract infection, interstitial cystitis, urinary tract obstruction, urethral diverticulum, bladder tumor, bladder stone)
- have given birth or have had pelvic, vaginal or bladder surgery less than 6 months before study enrollment
- with a second post-void residual urine volume > 150 mL at the time of screening (determined by abdominal ultrasound)
- with significant medical problems or other organ abnormality that places them at risk from participating in the study or at a significant risk of developing complete urinary retention
- with significant impairment of the liver or kidneys as determined by laboratory assessments or hematuria (red blood cells in microscopic urinalysis)
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 |
|---|---|---|
| oxybutynin chloride | Drug | – |
Primary outcome
The number of weekly urge urinary incontinence (Urge-UI) episodes at week 12, adjusted for the baseline value
1 secondary outcome
The number of total urinary incontinence (Total-UI) episodes at week 12; Void frequency at week 12; Urge-UI ,Total-UI, and Void frequence at weeks 2, 4, and 8; tolerability of the treatments during the 12-week treatment phase.
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 3 Feb 2025.
- Results publication: PubMed 12934777Diokno AC, Appell RA, Sand PK, Dmochowski RR, Gburek BM, Klimberg IW, Kell SH; OPERA Study Group. Prospective, randomized, double-blind study of the efficacy and tolerability of the extended-release formulations of oxybutynin and tolterodine for overactive bladder: results of the OPERA trial. Mayo Clin Proc. 2003 Jun;78(6):687-95. doi: 10.4065/78.6.687.
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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.
Alza Corporation Clinical Trial study director
ALZA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oxybutynin chloride in people with Urinary Incontinence, run by Alza Corporation, DE, USA.
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 5 inclusion and 5 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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The number of weekly urge urinary incontinence (Urge-UI) episodes at week 12, adjusted for the baseline value. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00293839, which also lists 1 linked publication.
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 3 Feb 2025.