Urinary IncontinencePhase 3NCT00304499
Efficacy and Safety of OROS Oybutynin and TTS Oxybutynin in Middle-Aged and Elderly Women With Urinary Incontinence
A Phase 3 study testing Oxybutynin in people with Urinary Incontinence, run by Alza Corporation, DE, USA.
Trial summary
The purpose of this study is to compare the side-effect profile and efficacy of sustained release, OROS® and TTS, dosage forms of oxybutynin with immediate release (IR) oral oxybutynin and with placebo. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Oxybutynin
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- Dec 1995to Dec 1996
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women, aged 40 years or older, with screening PUD demonstrating an average urinary frequency of 10 per 24 hours and urge incontinence episodes ³10 times per week and £ 60 times per week, and CMG demonstrating detrusor contraction and/or severe "must void" urge (score = 2) at a bladder filling volume of less than or equal to 400 mL
- Women with mixed incontinence provided that symptoms and/or signs of stress incontinence are not the predominant manifestation of UI and urge incontinence episodes associated with urgency can be differentiated from urge incontinence episodes not associated with urgency
- Patients who are mentally intact and capable of understanding and following the study requirements
- Each patient must be determined to be in good general health prior to study participation. The evaluation will be based on the medical history
- Physical examination (general, genital, pelvic, rectal)
- Laboratory tests including blood chemistry profile (glucose, blood urea nitrogen, uric acid, calcium, phosphorus, total protein, albumin, cholesterol, total bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, sodium, potassium, creatinine, bicarbonate and chloride)
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- Complete blood count (CBC) with differential and platelets
- Urinalysis with microscopic examination
- And electrocardiogram (EKG)
- Creatinine clearance (Ccr) will be estimated as 0.85 x (140-Age) x (body weight in Kg) ¸ (72 x serum creatinine in mg/dl). The estimated Ccr must be greater than 50 mL/min
- Normotensive with supine blood pressure between the range of 100 - 140 mm Hg systolic and 65-90 mm Hg diastolic, and no clinically significant postural hypotension 30 seconds and 2 minutes after standing. If patients are taking antihypertensive medications (may include calcium channel blockers but not undissolvable dosage forms), they must be normotensive on their antihypertensive medications. Patients should be on a stable dose of antihypertensive medications for at least 90 days before screening for the study and there should be no plan to change the dose of antihypertensive medications during the study
- Pre-menopausal women must be using a medically acceptable and effective birth control method (birth control pills or implants, IUD, diaphragm with spermicide, condoms with spermicide or spermicide-containing sponges) and have a negative urine pregnancy test at the time of screening
- Patients with positive urine cultures at screening may be treated with antibiotics and if urine cultures are negative following treatment and if the patient has been off antibiotics for a period of one week these patients may be rescreened. The patient's urine cultures should be negative before the patient begins recording the screening urinary diary and before the CMG
Who cannot join
- Patients with known genitourinary conditions (identified on history or on examination) that may cause incontinence (eg, urinary tract infection, obstruction, bladder tumor, bladder stone)
- Patients with clinically significant medical problems or other organ abnormality or pathology for whom, in the opinion of the investigator, administration of oxybutynin would present undue risk (cardiovascular, pulmonary, gastrointestinal, renal, endocrine, neurological, rheumatological, hematological, urologic, or psychiatric disorders including depression)
- Patients with glaucoma or untreated narrow anterior chamber angles (as determined by examination or history), obstructive disease or severe narrowing of the gastrointestinal tract, obstructive uropathy, or myasthenia gravis
- Patients receiving any drugs that are considered effective in the treatment of urinary incontinence including dicyclomine, imipramine, propantheline, hyoscyamine (Levsin®), flavoxate, phenylpropanolamine, prazosin, pseudoephedrine, baclofen (Lioresal®), or terodiline less than the equivalent of 5 times the half-life of the drug
- Patients who have been treated with anticholinergic agents for urge UI and have been found to be refractory to these agents. (Note: Patients who have been shown to be responders to anticholinergic medications may be included in the study after an appropriate wash-out period equivalent to 5 times the half-life of the anticholinergic drug)
- Concomitant medications (including over-the-counter medications) during the study with the exception of medications taken regularly for chronic conditions or intermittently for treatment of mild pain, (eg, acetaminophen, nonsteroidal anti-inflammatory drugs
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- Estrogen replacement therapy, oral contraceptives, diuretics, calcium channel blockers)
- Patients who have taken an investigational drug within a period of one month or 5 times the half-life of the drug (whichever is longer)
- Hemoglobin less than 10 g/dL
- Known allergy or hypersensitivity to oxybutynin
- Patients with history of drug or alcohol abuse (>2 drinks a day: 1 drink defined as 12-oz beer, or 1-oz hard liquor or 4-oz wine)
- Positive urine drug screen
- Pregnant or lactating
- Patients who, in the investigator's opinion, may not be capable of following the study schedule for any reason
About this study
Official title: Efficacy and Safety of OROS® Oxybutynin and TTS Oxybutynin in Middle-Aged and Elderly Women With Urinary Incontinence
The purpose of this study is to compare the side-effect profile and efficacy of sustained release, OROS® and TTS, dosage forms of oxybutynin with immediate release (IR) oral oxybutynin and with placebo.
Read the detailed description
Urinary incontinence (UI) refers to the involuntary loss of urine in sufficient amounts to be considered a social or health problem. While it is a psychologically distressing and socially disruptive, UI is believed to be an under reported and under diagnosed medical condition. This is a Multicenter, randomized, double-blind, placebo-controlled, parallel group study with 1 week of single-blinded placebo run-in. Patients will be randomized to 6 weeks double-blind treatment with oxybutynin or placebo. The primary hypothesis to be tested in this study is that the treatment difference in the change in incontinence episodes per week after 6 weeks of treatment in the double-blind phase between individual oxybutynin-treated group and combined placebo group is equal to zero.
The patients will receive oral OROS® containing oxybutynin, immediate release oral oxybutynin (1.7 or 2.5 mg) or TTS oxybutynin (60 cm2) daily for 7 weeks.
- Conditions
- Urinary Incontinence
- Being tested
- Oxybutynin
- Keywords
- OROS®, middle age, elderly, oxybutynin, urinary incontinenence, women
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxybutyninDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy parameter is the mean change in urge incontinence episodes per week from baseline to last week after up to 6 weeks double-blind treatment.
Secondary outcomes (1)
The secondary efficacy parameters are Mean incontinent episodes per week based on the Patient Urinary Diary (PUD); Mean diurnal and nocturnal micturition frequencies (PUD); Mean incontinence pads changed each day due to wetness (PUD).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2006 (estimated)
- Study startDec 1995
- Study completionDec 1996
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single group
- Masking
- Double blind
- Enrolment
- 176 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
- NCT00304499
- Sponsor's protocol ID
- CR005965
- Status last verified
- Apr 2010
- First submitted
- 17 Mar 2006
- Last updated
- 19 May 2011
- Results posted
- No
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
- Efficacy and Safety of OROS® Oxybutynin and TTS Oxybutynin in Middle-Aged and Elderly Women With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT00304499
- Acronym / sponsor ID
- CR005965
- Conditions
- Urinary Incontinence
- Keywords
- OROS®, middle age, elderly, oxybutynin, urinary incontinenence, women
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants
- Lead sponsor
- Alza Corporation, DE, USAIndustry (pharma, biotech, devices)
- Study start
- Dec 1995
- Study completion
- Dec 1996
- First posted
- 20 Mar 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 side-effect profile and efficacy of sustained release, OROS® and TTS, dosage forms of oxybutynin with immediate release (IR) oral oxybutynin and with placebo.
Detailed description
Urinary incontinence (UI) refers to the involuntary loss of urine in sufficient amounts to be considered a social or health problem. While it is a psychologically distressing and socially disruptive, UI is believed to be an under reported and under diagnosed medical condition. This is a Multicenter, randomized, double-blind, placebo-controlled, parallel group study with 1 week of single-blinded placebo run-in. Patients will be randomized to 6 weeks double-blind treatment with oxybutynin or placebo. The primary hypothesis to be tested in this study is that the treatment difference in the change in incontinence episodes per week after 6 weeks of treatment in the double-blind phase between individual oxybutynin-treated group and combined placebo group is equal to zero.
The patients will receive oral OROS® containing oxybutynin, immediate release oral oxybutynin (1.7 or 2.5 mg) or TTS oxybutynin (60 cm2) daily for 7 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Women, aged 40 years or older, with screening PUD demonstrating an average urinary frequency of 10 per 24 hours and urge incontinence episodes ³10 times per week and £ 60 times per week, and CMG demonstrating detrusor contraction and/or severe "must void" urge (score = 2) at a bladder filling volume of less than or equal to 400 mL
- Women with mixed incontinence provided that symptoms and/or signs of stress incontinence are not the predominant manifestation of UI and urge incontinence episodes associated with urgency can be differentiated from urge incontinence episodes not associated with urgency
- Patients who are mentally intact and capable of understanding and following the study requirements
- Each patient must be determined to be in good general health prior to study participation. The evaluation will be based on the medical history
- Physical examination (general, genital, pelvic, rectal)
Key exclusion criteria (14 listed)
- Patients with known genitourinary conditions (identified on history or on examination) that may cause incontinence (eg, urinary tract infection, obstruction, bladder tumor, bladder stone)
- Patients with clinically significant medical problems or other organ abnormality or pathology for whom, in the opinion of the investigator, administration of oxybutynin would present undue risk (cardiovascular, pulmonary, gastrointestinal, renal, endocrine, neurological, rheumatological, hematological, urologic, or psychiatric disorders including depression)
- Patients with glaucoma or untreated narrow anterior chamber angles (as determined by examination or history), obstructive disease or severe narrowing of the gastrointestinal tract, obstructive uropathy, or myasthenia gravis
- Patients receiving any drugs that are considered effective in the treatment of urinary incontinence including dicyclomine, imipramine, propantheline, hyoscyamine (Levsin®), flavoxate, phenylpropanolamine, prazosin, pseudoephedrine, baclofen (Lioresal®), or terodiline less than the equivalent of 5 times the half-life of the drug
- Patients who have been treated with anticholinergic agents for urge UI and have been found to be refractory to these agents. (Note: Patients who have been shown to be responders to anticholinergic medications may be included in the study after an appropriate wash-out period equivalent to 5 times the half-life of the anticholinergic drug)
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 | Drug | – |
Primary outcome
The primary efficacy parameter is the mean change in urge incontinence episodes per week from baseline to last week after up to 6 weeks double-blind treatment.
1 secondary outcome
The secondary efficacy parameters are Mean incontinent episodes per week based on the Patient Urinary Diary (PUD); Mean diurnal and nocturnal micturition frequencies (PUD); Mean incontinence pads changed each day due to wetness (PUD).
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.
- Efficacy and safety of OROS® (oxybutynin chloride) and D-TRANS � oxybutynin in middle-aged and elderly women with urinary incontinenceLink 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 Oxybutynin 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 13 inclusion and 14 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?
The primary efficacy parameter is the mean change in urge incontinence episodes per week from baseline to last week after up to 6 weeks double-blind treatment.. 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 19 May 2011.