Phase 4
N=345
An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder Participants
Urinary Bladder, Overactive
Bottom Line
View on ClinicalTrials.gov: NCT00613327 ↗Enrolled (actual)
345
Serious AEs
0.9%
Results posted
Sep 2013
Primary outcome: Primary: Percentage of Participants Who Achieved Treatment Goal — 40.45 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Oxybutynin chloride OROS (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Korea, Ltd., Korea
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Treatment Goal |
40.45 | — |
| SECONDARY Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12 |
1; 2; 0; 0; 0; 17 | — |
| SECONDARY Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12 |
3; 3; 0; 0; 0; 7 | — |
| SECONDARY Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12 |
15; 3; 1; 0; 0; 18 | — |
| SECONDARY Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12 |
63; 7; 5; 3; 3; 28 | — |
| SECONDARY Patient's Perception of Symptom Improvement (PPSI) Score for Overactive Bladder |
38.66 | — |
| SECONDARY Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire |
184; 45; 73; 1; 155; 86 | — |
| SECONDARY Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire |
0; 4; 25; 81; 137; 62 | — |
| SECONDARY Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12 |
50.08; -23.73; -25.63; 53.46; 18.96; 21.32 | — |
| SECONDARY Mean Voiding Frequency |
10.75; 8.22; 8.08; 1.96; 1.34; 1.26 | — |
| SECONDARY Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12 |
-20.36; -22.47; -13.91; -21.54; -22.19; -24.90 | — |
| SECONDARY Frequency of Urinary Urgency and Urinary Incontinence |
9.40; 5.11; 4.31; 0.911; 0.213; 0.224 | — |
| SECONDARY Percent Change From Baseline in Frequency of Urinary Urgency and Urinary Incontinence at Week 6 and 12 |
-39.16; -46.19; -56.42; -74.64 | — |
| SECONDARY Mean Severity of Urinary Urgency at Urination |
— | — |
| SECONDARY Visual Analogue Scale (VAS) Score for Dry Mouth |
20.30; 46.26; 43.85 | — |
| SECONDARY Percent Change From Baseline in Visual Analogue Scale (VAS) Score for Dry Mouth at Week 6 and 12 |
210.96; 171.90 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00613327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.