A Phase 4 interventional study of Oxybutynin transdermal system in Detrusor Hyperreflexia, sponsored by Watson Pharmaceuticals. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-04-30.
Sponsored by Watson Pharmaceuticals (part of AbbVie) · Phase 4, Interventional, and Treatment
This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury.
The Dose Titration Period began with a 3.9 mg/day or 7.8 mg/day as a starting dose after the completion of a 3-day diary for baseline evaluations, including urodynamic testing. The clean intermittent catheterization (CIC) frequency remained constant throughout the Dose Titration Period. The dose was adjusted every two weeks during the Dose Titration Period by increasing one dose level, at the investigator's discretion, based on the patient's symptoms. If a patient achieved complete continence and reported tolerable or absence of side effects, the patient was continued at that dose for the duration of the 8-week Titration Period. If a patient reported unacceptable side effects, the dose was reduced by one level. This reduced dose was considered the maximum tolerable dose for the patient and the patient continued at that dose for the duration of the 8-week Titration Period. The dose levels evaluated were 3.9 mg/day, 7.8 mg/day, 9.1 mg/day, and 11.7 mg/day. Of the 22 subjects in the modified intent-to-treat population evaluated for efficacy, 0 were in the 3.9 mg/day dose group, 3 were in the 7.8 mg/day dose group, 8 were in the 9.1 mg/day dose group, and 11 were in the 11.7 mg/day dose group.
18 studies on the registry are indexed under Reflex, Abnormal; 1 is open to participants now.
This study's enrollment of 24 is above the median of 16 across 13 interventional studies indexed under Reflex, Abnormal.
Browse Reflex, Abnormal studies →Watson Pharmaceuticals is the lead sponsor of 30 studies on the registry; none are open to participants now.
First submitted before Watson Pharmaceuticals became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oxybutynin transdermal system 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day dosing
Drug: Oxybutynin transdermal system
3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration
Also known as: Oxytrol
Average Number of Catheterizations Without Leaking Per Day
Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary.
Time frame: 8 weeks
Patch Adhesion
Time frame: 8 weeks
Urodynamic Measurements
Time frame: 8 weeks
Urinary Leakage and Catheterization Data
Time frame: 8 weeks
| Milestone | Oxybutynin Transdermal System |
|---|---|
| Started | 24 |
| Completed | 18 |
| Not completed | 6 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Other | 1 |
Baseline in number of daily catheterizations without leaking per day as recorded in a 3-day urinary diary.
| Number of Dry Catheterizations per Day | Oxybutynin Transdermal System |
|---|---|
| Baseline at Week 0 | 2.4 ± 1.8 |
| Change from baseline at Week 8 | 1.5 ± 2.2 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oxybutynin Transdermal System | — | 0/24 (0%) | 11/24 (45.8%) |
| Event | Oxybutynin Transdermal System |
|---|---|
| Infection urinary tractRenal and urinary disorders | 3/24 |
| Dry mouthGastrointestinal disorders | 2/24 |
| HeadacheGeneral disorders | 2/24 |
| SweatSkin and subcutaneous tissue disorders | 2/24 |
| Vision abnormalEye disorders | 2/24 |
| Age, Categorical(Participants) | Oxybutynin Transdermal System |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 24 |
| >=65 years | 0 |
| Age Continuous(years) | Oxybutynin Transdermal System |
|---|---|
| Mean | 41.9 ± 10.35 |
| Sex: Female, Male(Participants) | Oxybutynin Transdermal System |
|---|---|
| Female | 3 |
| Male | 21 |
| Region of Enrollment(participants) | Oxybutynin Transdermal System |
|---|---|
| United States | 24 |
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oxybutynin