An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder Participants
Information source: Janssen Korea, Ltd., Korea
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Bladder, Overactive
Intervention: Oxybutynin chloride OROS (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen Korea, Ltd., Korea Official(s) and/or principal investigator(s): Janssen Korea, Ltd. Clinical Trial, Study Director, Affiliation: Janssen Korea, Ltd.
Summary
The objective of this study is to evaluate the efficacy of oxybutynin chloride oral osmotic
therapeutic system (OROS) on patient-reported outcomes after 12 weeks of treatment by dose
escalation in participants with overactive bladder.
Clinical Details
Official title: The Efficacy of Oxybutynin Chloride OROS in Patient-Reported Outcomes With Dose Escalation in Korean Overactive Bladder Patients
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants Who Achieved Treatment Goal
Secondary outcome: Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12 Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12 Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12 Patient's Perception of Symptom Improvement (PPSI) Score for Overactive Bladder Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12 Mean Voiding Frequency Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12 Frequency of Urinary Urgency and Urinary Incontinence Percent Change From Baseline in Frequency of Urinary Urgency and Urinary Incontinence at Week 6 and 12 Mean Severity of Urinary Urgency at Urination Visual Analogue Scale (VAS) Score for Dry Mouth Percent Change From Baseline in Visual Analogue Scale (VAS) Score for Dry Mouth at Week 6 and 12
Detailed description:
This is a multicenter (when more than one hospital or medical school team work on a medical
research study), open-label (all people know the identity of the intervention), prospective
(study following participants forward in time) Phase 4 study of oxybutynin chloride OROS in
participants with overactive bladder. The total study duration will be 12 weeks and will
include following visits: Screening (Week - 2), Baseline, Week 2, 4, 6 and 12. Participants
will receive oxybutynin chloride OROS tablet at starting dose of 10 milligram (mg) orally
once daily. The dose will be adjusted by 10 mg every 2 weeks up to first 6 weeks, based on
the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks will
be continued up to Week 12. Maximum allowed dose will be 30 mg per day. Efficacy will
primarily be evaluated by assessment of goal achievement (percentage of participants who
show a score 4 or 5 in the Likert scale for treatment goal) at Week 12. Participants' safety
will also be monitored at each visit.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Participants who fulfilled all of the following criteria in their micturition charts
completed for 3 days prior to visit 2 (Baseline): mean voiding frequency greater than
or equal to 8 times per 24 hours and mean frequency of urinary urgency greater than
or equal to 2 times per 24 hours (urgency means sudden and strong urge to urinate and
a urinary sensation scale score greater than or equal to 3 in the micturition chart)
- Participants with overactive bladder symptoms lasting for 3 months or longer prior to
study initiation
- Participants who were capable of completing micturition chart and survey
questionnaires and provided informed consent to complete them
- Participants who could sign on the informed consent form after fully listening to and
understanding about characteristics, risks and benefits of the study
Exclusion Criteria:
- Participants with stress urinary incontinence (not able to control bladder actions)
or participants with complicated incontinence dominantly presenting stress urinary
incontinence when judging based on medical history
- Participants with a hepatic (pertaining to liver) or renal (pertaining to kidneys)
disease indicating serum aspartate transaminase (AST [SGOT]), alanine transaminase
(ALT [SGPT]), alkaline phosphatase or creatinnine concentration twice or more of
normal upper limit
- Participants contraindicated to use anticholinergics including uncontrolled narrow
angle glaucoma (increased pressure inside the eye that causes visual problems),
urinary retention or gastrointestinal tract retention
- Participants experiencing a symptom of acute urinary tract infection (UTI) during the
run-in period
- Participants with recurrent UTI who had medical history of treatment for UTI symptom
5 times or more in the past one year
Locations and Contacts
Additional Information
Starting date: September 2007
Last updated: October 24, 2013
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