A Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy, Safety, and Tolerability of JNJ-42160443 in Subjects With Interstitial Cystitis/ Painful Bladder Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 31
- 主要终点
- The change in the average pain intensity score.
研究概览
简要总结
The purpose of this study is to evaluate the analgesic efficacy, safety, and tolerability of JNJ-42160443 compared to placebo in patients with moderate to severe, chronic bladder pain from interstitial cystitis and/or painful bladder syndrome.
详细描述
This study is a randomized (study drug assigned by chance), double-blind (neither the physician nor the patient knows the name of the assigned drug) study to evaluate the analgesic efficacy, safety, and tolerability of JNJ-42160443 compared with placebo in patients with moderate to severe, chronic bladder pain from Interstitial cystitis (IC) and/or painful bladder syndrome (PBS). Interstitial cystitis (IC) and PBS are urological disorders characterized by symptoms of bladder pain, urinary urgency, urinary frequency, and the need to get up during the night in order to urinate. The study has 3 phases: a screening phase (up to 3 weeks), a double-blind treatment phase (12 weeks), and a post-treatment phase that ends 26 weeks after the last dose of study medication. The study duration will be approximately 36 to 46 weeks.
A single dose of JNJ-42160443 (9 mg/ml) or matching placebo given as an injection under the skin once every 4 weeks for up to 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic pelvic pain (>6 months) perceived to be related to the urinary bladder and accompanied by urinary symptoms such as frequent urination during the day and/or night, and/or urgency to void
- •Total score of 8 or greater on the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)
- •The mean of the average pain intensity scores at screening phase >=5 (on a scale of 0 to 10)
- •Medically stable
排除标准
- •Urinary culture is positive for a urinary tract infection; Recent invasive therapy to the bladder
- •History or current conditions indicating that the bladder pain can be caused by diagnoses other than IC/PBS (eg, pain caused by a confirmed or suspected neoplasm)
- •History of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been successfully treated
- •Women who are pregnant or breast-feeding
- •A body mass index (BMI) of >39 kg/m2
研究组 & 干预措施
JNJ-42160443
干预措施: JNJ-42160443 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The change in the average pain intensity score.
时间窗: The change from baseline to the end of the double-blind phase in the mean average pain intensity score (12 weeks).
次要结局
- Evaluation of Global Response Assessment (GRA)(12 weeks)
- Changes from baseline to end of the double-blind phase in subscale scores of the Short Form (SF)-12 Health Survey(12 weeks)
- Antibody against JNJ-42160443(34 weeks)
- Changes from baseline in O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI)(12 weeks)
- Change in Pelvic Pain and Urgency/Frequency Questionnaire (PUF)(12 weeks)