URACYST® For the Treatment of GAG Deficient Interstitial Cystitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Percentage of Responders to Treatment
研究概览
简要总结
This protocol describes a multi-centre, community based open label study designed to assess the efficacy and safety of intravesical sodium chrondroitin sulfate (Uracyst®) in the treatment of patients with a clinical diagnosis of interstitial cystitis (IC).
The safety of the study product will be evaluated through the incidence of adverse events and from results of physical examinations and laboratory tests.
详细描述
The primary efficacy endpoint will be the percent responders to treatment as indicated by improvement on a seven-point Patient Global Assessment scale at week 10 (after 6 treatments) compared to baseline. The patient evaluates the overall change in their condition as markedly improved, moderately improved, slightly improved, no change, slightly worse, moderately worse or markedly worse.
Secondary efficacy objectives will be as follows:
- Improvement in individual IC symptoms during the treatment period and at week 10 (after 6 treatments) compared to baseline.
Pain and urgency scores (0-10 cm VAS) will be obtained using patient on-site questionnaires prior to first treatment (baseline), and again for weeks 4, 6, 10, 14, 18, 22 and 24. 2. Change in Patient Symptom/Problem Index scores over the course of the treatment until the end of study (week 24) compared to baseline.
The validated O'Leary Symptom Problem/Index will be completed prior to first treatment (baseline) and again for weeks 4, 6, 10, 14, 18, 22 and 24.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must meet the following eligibility criteria in order to be enrolled in this study.
- •Clinical diagnosis of interstitial cystitis
- •Legally majority female capable and willing to provide informed consent
- •Negative blood test for pregnancy at baseline or assurance of previous surgery, condition or state rendering conception impossible
- •A sterile bacterial urine culture no more than thirty (30) days prior to first treatment
- •An average urinary frequency of at least 11 times per 24-hour day
- •An average pain/discomfort score of 4 or greater on a 0-10cm VAS scale
- •Available for the duration of the study including treatment and follow-up (4 months)
排除标准
- •Pregnant or lactating
- •Currently receiving or having received investigational drugs thirty (30) days or less prior to screening
- •Currently receiving or having had prior therapy with intravesical treatment (eg. Uracyst, Cystistat®, heparin or BCG)
- •Receiving therapy for less than three months with antidepressants, antihistaminics, hormonal agonists or antagonists; hence patient not stabilized on therapy. (Stable therapy defined as continuous treatment for at least three months.)
- •Currently receiving or having received prior therapy with oral pentosanpolysulfate (Elmiron) 3 months or less prior to screening
- •IC symptoms relieved by antimicrobials, anticholinergics or antispasmodics
- •Bladder capacity of greater than 500 ml on awake cystometry using liquid filling medium
- •Neurologic disease affecting bladder function; any previous surgery or procedure having affected bladder function
- •Current urinary tract infection (must be treated and have a negative culture before study entry)
- •Current diagnosis of chemical, tuberculous or radiation cystitis
- •History of bladder or lower ureteral calculi
- •History of cancer within the last five years other than adequately treated non-melanoma skin cancers
- •Active sexual transmitted disease
- •Current vaginitis
- •Endometriosis
- •Any condition/disease which in the opinion of the investigator could interfere with patient compliance and/ or interfere with the interpretation of the treatment results
结局指标
主要结局
Percentage of Responders to Treatment
时间窗: Week 10 (4 weeks after the initial six treatments
indicated by a marked or moderate improvement on a seven-point patient Global Response Assessment (GRA) scale compared with baseline
次要结局
- Change in Likert Pain Score From Baseline at 10 Weeks(Baseline and 10 Weeks)
研究者
Dr. J. Curtis Nickel
Principal Investigator
Queen's University