NCT01437670已完成不适用
A Prospective, Multicenter, Observation Study to Estimate the Dry Mouth in OAB Patients With Solifenacin
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- The changes of the total score in Xerostomia inventory XI from baseline
研究概览
简要总结
A prospective, multicenter, observation study to estimate the dry mouth in OAB patients with solifenacin
详细描述
To estimate the dry mouth and their impact on the efficacy of the drug in overactive bladder patients with solifenacin
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male or female patients with 20 years of age or older 2) clinical history of OAB for at least 3 months prior to visit 2 3) more than 3 in total score and 2 in Q 3 index from OABSS questionnaire
排除标准
- •In clinical trial, female with pregnant, intent to become pregnant or breast-feeding 2)post-voided residual urine volume > 150ml 3) a history of catheterization due to acute urinary retention 4) a history of pelvic surgery within 6 months 5) 6) 7) a history of neurovascular disease such as Parkinson's disease, cerebral vascular disease, spinal injury or multiple sclerosis 8)patients with indwelling catheter or intermittent catheterization 9) active or recurrent (>3 episodes per year) urinary tract infection 10) the use of the following medication at least 2 weeks
- •anticholinergics
- •Tricyclic antidepressants,anti-epilepsy drug, anti-Parkinson's disease drug, anti-arrythmia drug type I
- •Chlorpromazine, Thioridazine, Piperazine
- •MAO inhibitor 11) Patient is currently taking or has taken within the past 4 weeks alpha-blocker for the treatment of benign prostatic hypertrophy 12) Patient is currently taking or has taken within the past 8 weeks 5ARI or estrogen medication 13) Patient is currently using or has used medications with known activities as inhibitors or inducers of cytochrome P4503A4 (CYP3A4)
研究组 & 干预措施
dry mouth patients with solifenacin
dry mouth patients with solifenacin 5mg, 10mg
干预措施: solifenacin 5mg, 10mg (Drug)
结局指标
主要结局
The changes of the total score in Xerostomia inventory XI from baseline
时间窗: after 8 weeks of treatment from baseline
11-item summated rating scale. Respondents were asked to choose one of five responses ('never', scoring 1\~'very often', 5) total best and worst values: 11 and 49
次要结局
- Global response assessment(after 8 weeks of treatment from baseline)
- The changes of the total score in overactive bladder symptom score (OABSS) from baseline(after 8 weeks treatment from baseline)
- Visual Analog Scale (VAS) of dry mouth(after 8 weeks treatment from baseline)
研究者
Myung-Soo Choo
Professor
Asan Medical Center
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Improvement of Dry Mouth Sufferers After Using an Experimental Dry Mouth Rinse Compared to a Water ControlDry MouthNCT04189081Procter and Gamble137
终止
不适用
Benefits of Standard ONS in Indian AdultsPoor NutritionNCT03713463Abbott Nutrition59
已完成
不适用
Pharmacogenetics Sampling of the CC-90007-CP-003 Study CohortHepatic InsufficiencyNCT04097704Celgene28
进行中（未招募）
不适用
Effect of Oxygenated Mouthwash and Mouth FoamGingival DiseasesPlaque, DentalQuality of LifeNCT06079307King's College London60
尚未招募
不适用
Post Surgical Multimodal Analgesia With Oral Strong OpioidsOrthopedic ProceduresArthroplastyFracture FixationNCT06554457Tri-Service General Hospital200