Urge IncontinencePhase 3NCT00269750
A Study Comparing the Efficacy and Safety of OROS® Oxybutynin to That of Ditropan® (Immediate-release Oxybutynin) for the Treatment of Patients With Urge or Mixed Urinary Incontinence.
A Phase 3 study testing OROS® oxybutynin or Ditropan® in people with Urge Incontinence, run by Alza Corporation, DE, USA.
Trial summary
The purpose of this study is to compare the efficacy and safety of OROS® oxybutynin to that of Ditropan® (immediate-release oxybutynin) for the treatment of patients with urge or mixed urinary incontinence. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Urge Incontinence
- What is being tested?
- OROS® oxybutynin or Ditropan®
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 1996to Feb 1997
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with urge or mixed urinary incontinence, provided that stress urinary incontinence is not the predominant manifestation of mixed urinary incontinence
- Patients who are currently taking immediate release oxybutynin (Ditropan®) hyoscyamine (Levsin®) or propantheline (Pro-banthine®), or who have taken Ditropan in the past for urge or mixed UI. (Patients who have taken Ditropan for urge or mixed urinary incontinence, but who have discontinued the medication should have discontinued due to anticholinergic effects and not due to failure of efficacy)
- Patients who are able to differentiate incontinent episodes associated with urgency from incontinent episodes not associated with urgency when recording incontinent episodes in the diary, who have at least six urge urinary incontinence episodes per week recorded on the Run-in Diary after washout of anticholinergic medications, and who demonstrate that the number of urge incontinent episodes per week is greater than the number of incontinent episodes not associated with urgency per week
- Patients who are in good general health prior to study participation, having normal blood pressure with or without hypertension medication
- Agreeing that a medically acceptable and effective birth control method will be used by the patient and partner throughout the study and for one week following the end of the study
Who cannot join
- Patients with known treatable genitourinary conditions that may cause incontinence (e.g., urinary tract infection, prostatitis, urinary tract obstruction, bladder tumor, bladder stone, prostate cancer)
- Patients with glaucoma or untreated narrow anterior chamber angles, obstructive bowel disease or severe narrowing of the gastrointestinal tract, obstructive uropathy, or myasthenia gravis
- Patients with known allergy or hypersensitivity to oxybutynin or clinically significant medical problems or other organ abnormality or pathology for whom, administration of oxybutynin would present undue risk
- Male patients with a PSA > 10 ng/mL or a PSA between 4 ng/mL and 10 ng/mL who in the opinion of the investigator require further evaluation or treatment for prostate cancer, or male patients who have had prostate surgery less than nine months before study enrollment. (Prostate pathology from surgery must be benign)
- Patients whose estimated creatinine clearance is less than 50 mL/min or a have hemoglobin level less than 10 g/dL
About this study
Official title: The Maximum Tolerated Dose and Minimum Effective Dose of OROS® Oxybutynin Compared to Ditropan® (Immediate-release Oxybutynin) in the Treatment of Patients With Urge or Mixed Urinary Incontinence
The purpose of this study is to compare the efficacy and safety of OROS® oxybutynin to that of Ditropan® (immediate-release oxybutynin) for the treatment of patients with urge or mixed urinary incontinence. Oxybutynin is an antispasmodic, anticholinergic medication for the treatment of the symptoms of overactive bladder.
Read the detailed description
Ditropan® is indicated for the treatment of urge urinary incontinence, however patients tend to discontinue the medication or decrease the dose due to anticholinergic side effects. OROS® oxybutynin, a continuous release formulation, is expected to have fewer anticholinergic side effects than Ditropan® and may provide equal or better efficacy compared to Ditropan®. This is a randomized, multi-center, double-blind, parallel group, dose-escalation study comparing the efficacy and safety of OROS® oxybutynin to Ditropan® for the treatment of urge or mixed urinary incontinence at the minimum effective dose (MED), the maximum tolerated dose (MTD), or the maximum allowable dose (MAD) permitted under this protocol. Patients in both treatment groups begin study drug treatment at an oxybutynin dose of 5 mg per day. The dose is changed in 5 mg increments at 4- to 7-day intervals, depending on the safety and efficacy of the current dose. The maximum allowable dose for Ditropan® is 20 mg per day, which is the maximum daily adult dose specified in its labeling. Because controlled delivery of oxybutynin by an OROS® dosage form could potentially reduce side effects, it is believed that the drug could possibly be tolerated at doses higher than 20 mg per day. Consequently, the maximum allowable dose for OROS® oxybutynin is 30 mg per day, administered as a single daily dose. The primary measures of effectiveness include the change from baseline in the following assessments: the number of urge urinary incontinence episodes per week, the total number of urinary incontinence episodes, and total void frequency (normal and incontinent). Safety evaluations include the incidence of adverse events, physical examination and medical history, clinical laboratory tests, urinalysis, electrocardiograms (ECGs), vital signs, and the Anticholinergic Effects Assessment (ACEA) questionnaire.
OROS® (oxybutynin chloride) 5 mg tablets, one to six tablets per day (5 mg/day to 30 mg/day) as a single morning oral dose for 11 days up to 70 days, and Ditropan (oxybutynin chloride) 5 mg tablets, one to four tablets per day orally (5 mg per day to 5 mg four times per day) for 10 daysup to 61 days.
- Conditions
- Urge Incontinence
- Being tested
- OROS® oxybutynin or Ditropan®
- Keywords
- Ditropan®, OROS®, urge, oxybutynin, mixed urinary incontinence
- Medical subject headings
- Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OROS® oxybutynin or Ditropan®Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in: the number of urge urinary incontinence episodes per week; total number of urinary incontinence episodes; total void frequency (normal and incontinent)
Secondary outcomes (1)
Incidence of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2005 (estimated)
- Study startJul 1996
- Study completionFeb 1997
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 Urge 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
- 100 participants
Sponsor and investigators
- Lead sponsor
- Alza Corporation, DE, USA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Alza Corporation Clinical Trial, Study director, Alza Corporation, DE, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269750
- Sponsor's protocol ID
- CR005968
- Status last verified
- Apr 2010
- First submitted
- 22 Dec 2005
- Last updated
- 19 May 2011
- Results posted
- No
Publications
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PubMed 37160401
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Maximum Tolerated Dose and Minimum Effective Dose of OROS® Oxybutynin Compared to Ditropan® (Immediate-release Oxybutynin) in the Treatment of Patients With Urge or Mixed Urinary Incontinence
- ClinicalTrials.gov ID
- NCT00269750
- Acronym / sponsor ID
- CR005968
- Conditions
- Urge Incontinence
- Keywords
- Ditropan®, OROS®, urge, oxybutynin, mixed urinary incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Alza Corporation, DE, USAIndustry (pharma, biotech, devices)
- Study start
- Jul 1996
- Study completion
- Feb 1997
- First posted
- 26 Dec 2005 (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 and safety of OROS® oxybutynin to that of Ditropan® (immediate-release oxybutynin) for the treatment of patients with urge or mixed urinary incontinence. Oxybutynin is an antispasmodic, anticholinergic medication for the treatment of the symptoms of overactive bladder.
Detailed description
Ditropan® is indicated for the treatment of urge urinary incontinence, however patients tend to discontinue the medication or decrease the dose due to anticholinergic side effects. OROS® oxybutynin, a continuous release formulation, is expected to have fewer anticholinergic side effects than Ditropan® and may provide equal or better efficacy compared to Ditropan®. This is a randomized, multi-center, double-blind, parallel group, dose-escalation study comparing the efficacy and safety of OROS® oxybutynin to Ditropan® for the treatment of urge or mixed urinary incontinence at the minimum effective dose (MED), the maximum tolerated dose (MTD), or the maximum allowable dose (MAD) permitted under this protocol. Patients in both treatment groups begin study drug treatment at an oxybutynin dose of 5 mg per day. The dose is changed in 5 mg increments at 4- to 7-day intervals, depending on the safety and efficacy of the current dose. The maximum allowable dose for Ditropan® is 20 mg per day, which is the maximum daily adult dose specified in its labeling. Because controlled delivery of oxybutynin by an OROS® dosage form could potentially reduce side effects, it is believed that the drug could possibly be tolerated at doses higher than 20 mg per day. Consequently, the maximum allowable dose for OROS® oxybutynin is 30 mg per day, administered as a single daily dose. The primary measures of effectiveness include the change from baseline in the following assessments: the number of urge urinary incontinence episodes per week, the total number of urinary incontinence episodes, and total void frequency (normal and incontinent). Safety evaluations include the incidence of adverse events, physical examination and medical history, clinical laboratory tests, urinalysis, electrocardiograms (ECGs), vital signs, and the Anticholinergic Effects Assessment (ACEA) questionnaire.
OROS® (oxybutynin chloride) 5 mg tablets, one to six tablets per day (5 mg/day to 30 mg/day) as a single morning oral dose for 11 days up to 70 days, and Ditropan (oxybutynin chloride) 5 mg tablets, one to four tablets per day orally (5 mg per day to 5 mg four times per day) for 10 daysup to 61 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with urge or mixed urinary incontinence, provided that stress urinary incontinence is not the predominant manifestation of mixed urinary incontinence
- Patients who are currently taking immediate release oxybutynin (Ditropan®) hyoscyamine (Levsin®) or propantheline (Pro-banthine®), or who have taken Ditropan in the past for urge or mixed UI. (Patients who have taken Ditropan for urge or mixed urinary incontinence, but who have discontinued the medication should have discontinued due to anticholinergic effects and not due to failure of efficacy)
- Patients who are able to differentiate incontinent episodes associated with urgency from incontinent episodes not associated with urgency when recording incontinent episodes in the diary, who have at least six urge urinary incontinence episodes per week recorded on the Run-in Diary after washout of anticholinergic medications, and who demonstrate that the number of urge incontinent episodes per week is greater than the number of incontinent episodes not associated with urgency per week
- Patients who are in good general health prior to study participation, having normal blood pressure with or without hypertension medication
- Agreeing that a medically acceptable and effective birth control method will be used by the patient and partner throughout the study and for one week following the end of the study
Key exclusion criteria (5 listed)
- Patients with known treatable genitourinary conditions that may cause incontinence (e.g., urinary tract infection, prostatitis, urinary tract obstruction, bladder tumor, bladder stone, prostate cancer)
- Patients with glaucoma or untreated narrow anterior chamber angles, obstructive bowel disease or severe narrowing of the gastrointestinal tract, obstructive uropathy, or myasthenia gravis
- Patients with known allergy or hypersensitivity to oxybutynin or clinically significant medical problems or other organ abnormality or pathology for whom, administration of oxybutynin would present undue risk
- Male patients with a PSA > 10 ng/mL or a PSA between 4 ng/mL and 10 ng/mL who in the opinion of the investigator require further evaluation or treatment for prostate cancer, or male patients who have had prostate surgery less than nine months before study enrollment. (Prostate pathology from surgery must be benign)
- Patients whose estimated creatinine clearance is less than 50 mL/min or a have hemoglobin level less than 10 g/dL
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 |
|---|---|---|
| OROS® oxybutynin or Ditropan® | Drug | – |
Primary outcome
Change from baseline in: the number of urge urinary incontinence episodes per week; total number of urinary incontinence episodes; total void frequency (normal and incontinent)
1 secondary outcome
Incidence of adverse events
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 19 May 2011.
- Derived from this study: PubMed 37160401Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
- The maximum tolerated dose and minimum effective dose of OROS® oxybutynin compared to Ditropan® in the treatment of patients with urge or mixed urinary incontinence (UI)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.
Alza Corporation Clinical Trial study director
Alza Corporation, DE, USA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing OROS® oxybutynin or Ditropan® in people with Urge 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 19 May 2011. 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?
Change from baseline in: the number of urge urinary incontinence episodes per week; total number of urinary incontinence episodes; total void frequency (normal and incontinent). 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 NCT00269750, 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 19 May 2011.