Clinical trial NCT00613327: An Efficacy and Safety Study of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) in Korean Overactive Bladder Participants
Official title: The Efficacy of Oxybutynin Chloride OROS in Patient-Reported Outcomes With Dose Escalation in Korean Overactive Bladder Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urinary Bladder, Overactive
Keywords: Overactive bladder
Oxybutynin chloride
OROS
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2008-02-13
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Percentage of Participants Who Achieved Treatment Goal
timeFrame: Week 12
Secondary outcomes:
measure: Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12
timeFrame: Baseline and Week 12
measure: Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12
timeFrame: Baseline and Week 12
measure: Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12
timeFrame: Baseline and Week 12
measure: Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urge Urinary Incontinence at Week 12
timeFrame: Baseline and Week 12
measure: Patient's Perception of Symptom Improvement (PPSI) Score for Overactive Bladder
timeFrame: Week 12
measure: Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire
timeFrame: Week 2, 4, 6 and 12
measure: Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire
timeFrame: Baseline and Week 12
measure: Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12
timeFrame: Baseline, Week 6, 12 or early discontinuation (ED)
measure: Mean Voiding Frequency
timeFrame: Baseline, Week 6, 12 or ED
measure: Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12
timeFrame: Baseline, Week 6, 12 or ED
measure: Frequency of Urinary Urgency and Urinary Incontinence
timeFrame: Baseline, Week 6, 12 or ED
measure: Percent Change From Baseline in Frequency of Urinary Urgency and Urinary Incontinence at Week 6 and 12
timeFrame: Baseline, Week 6, 12 or ED
measure: Mean Severity of Urinary Urgency at Urination
timeFrame: Baseline, Week 6, 12 or ED
measure: Visual Analogue Scale (VAS) Score for Dry Mouth
timeFrame: Baseline, Week 6, 12 or ED
measure: Percent Change From Baseline in Visual Analogue Scale (VAS) Score for Dry Mouth at Week 6 and 12
timeFrame: Baseline, Week 6, 12 or ED
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd.
name: Janssen Korea, Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: