The Efficacy of Oxybutynin Chloride OROS in Patient-Reported Outcomes With Dose Escalation in Korean Overactive Bladder Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 345
- 主要终点
- Percentage of Participants Who Achieved Treatment Goal
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Oxybutynin Chloride OROS
干预措施: Oxybutynin chloride OROS (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved Treatment Goal
时间窗: Week 12
Goal achievement was measured by using the 6-point Likert scale (0=not achieved at all and 5=completely achieved). Achievement of treatment goal was defined by a score of 4 or 5 in the Likert scale. Percentage of participants who achieved their treatment goal defined at Baseline (for a maximum of 3 items among the 10 items including incontinence, urinary urgency, frequent urination, nocturnal frequent urination, tenesmus, general health, life habit, activity, pain/pressure pain, and sexual function) was reported.
次要结局
- Mean Severity of Urinary Urgency at Urination(Baseline, Week 6, 12 or ED)
- Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Urinary Urgency at Week 12(Baseline and Week 12)
- Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Daytime Urination at Week 12(Baseline and Week 12)
- Visual Analogue Scale (VAS) Score for Dry Mouth(Baseline, Week 6, 12 or ED)
- Number of Participants With Change From Baseline in Response to Primary Overactive Bladder (OAB) Symptom Questionnaire (POSQ): Frequent Nighttime Urination at Week 12(Baseline and 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(Baseline and Week 12)
- Patient's Perception of Symptom Improvement (PPSI) Score for Overactive Bladder(Week 12)
- Number of Participants With Response to Patient's Perception of Treatment Benefit (PPTB) Questionnaire(Week 2, 4, 6 and 12)
- Number of Participants With Response to Patient's Perception of Bladder Condition (PPBC) Questionnaire(Baseline and Week 12)
- Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Score at Week 6 and 12(Baseline, Week 6, 12 or early discontinuation (ED))
- Mean Voiding Frequency(Baseline, Week 6, 12 or ED)
- Percent Change From Baseline in Mean Voiding Frequency at Week 6 and 12(Baseline, Week 6, 12 or ED)
- Frequency of Urinary Urgency and Urinary Incontinence(Baseline, Week 6, 12 or ED)
- Percent Change From Baseline in Frequency of Urinary Urgency and Urinary Incontinence at Week 6 and 12(Baseline, Week 6, 12 or ED)
- Percent Change From Baseline in Visual Analogue Scale (VAS) Score for Dry Mouth at Week 6 and 12(Baseline, Week 6, 12 or ED)