Randomized, Double-Blind, Placebo-Controlled, Parallel Group Evaluation of the Efficacy and Tolerability of Two Different Doses of ELMIRON for the Treatment of Interstitial Cystitis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 369
- 主要终点
- Number of Responders Defined as Having at Least a 30% Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of pentosan polysulfate sodium 100 mg once a day, pentosan polysulfate sodium 100 mg three times a day, and placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis.
详细描述
The purpose of this multi-center, double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), parallel group trial is to evaluate the effectiveness and safety of two doses of pentosan polysulfate sodium (100 mg once a day and 100 mg three times a day) versus placebo for 24 weeks for the relief of bladder pain or discomfort associated with interstitial cystitis. The hypothesis of the study is that there is no treatment difference in the proportion of responders at study endpoint (Week 24). Effectiveness will be assessed based on the reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) total score. Safety assessments include vital signs, laboratory tests, adverse events and physical exams. Patients will receive one of the following study treatments by mouth each day for 24 weeks: pentosan polysulfate sodium 100 mg once a day group - one pentosan polysulfate sodium 100 mg capsule in the morning, and one matching placebo capsule in the afternoon and evening; pentosan polysulfate sodium 100 mg capsule three times a day group - one pentosan polysulfate sodium 100 mg capsule in the morning, afternoon and evening; placebo group - one placebo capsule in the morning, afternoon and evening
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
- Triple (Participant, Care Provider, Investigator)
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
- •Must have a total score of 8 or greater on the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) and a score of > 0 on each of the 4 questions on the ICSI
- •must have experienced bladder pain, urinary urgency and urinary frequency, each not related to a urinary tract infection, for at least 6 months prior to entry into the study
- •must have averaged >= 10 voids per day (>=30 voids over 3 consecutive days) and averaged >= 1 void at night
- •urine culture showing no evidence of urinary tract infection
- •urine cytology showing no evidence of neoplastic cells
排除标准
- •Scheduled for or use of intravesical therapy (eg, bladder distention, dimethyl sulfoxide) during or within 4 weeks prior to the study
- •patients who have had cytoscopic evaluation within 4 weeks prior to the study
- •patients who are currently (within last month) receiving other medications that may affect symptoms of interstitial cystitis (ie, antidepressants, antihistamines, antispasmodics, anticholinergics)
- •patients who are chronic users of Schedule II narcotics or who are using any scheduled narcotics at the time of study entry
- •patients taking coumadin, anticoagulants, heparin, or thrombolytic agents such as tissue plasminogen activator and streptokinase
研究组 & 干预措施
Pentosan polysulfate sodium 100 mg once a day
One 100 mg pentosan polysulfate sodium capsule in the morning and 1 matching placebo capsule in the afternoon and evening for 24 weeks
干预措施: Pentosan polysulfate sodium 100 mg (Drug)
Pentosan polysulfate sodium 100 mg three times a day
One 100 mg pentosan polysulfate sodium capsule 3 times a day (morning afternoon and evening) for 24 weeks
干预措施: Pentosan polysulfate sodium 100 mg (Drug)
Placebo
Placebo One placebo capsule 3 times a day (morning afternoon and evening) for 24 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Responders Defined as Having at Least a 30% Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint
时间窗: Baseline to Week 24
The ICSI is a four-item self-administered instrument developed for the evaluation and management of patients with interstitial cystitis. The index measures the presence and extent of symptoms including urinary urgency, urinary frequency, nocturia and pain/burning in the bladder. Each question in the ICSI is on a 0-5 scale, where each answer is given a specific rating. The sum of the individual question ratings is the score for the ICSI. The range of the test is a score of 0 to 20. A lower score indicates a better condition.
次要结局
- Number of Responders Defined as Having at Least a Four Point Reduction in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) From Baseline to Study Endpoint(Baseline to Week 24)