A Single-Center, Double-Blind, Randomized, Dose-Ranging, Placebo Controlled Trial Comparing the Safety, Tolerability and Efficacy of LP-08 With Placebo in Subjects With Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Safety of Intravesical LP08: number/severity of adverse events
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of two doses of LP08 compared to placebo. Hypothesis: Safety of the LP-08 therapy will not be significantly different from the placebo group. Secondary Efficacy Endpoints: A matched-pair data analysis design will be employed, i.e. the measured outcomes will be subjects' improvements in quantitative and qualitative measures of the disease condition being assessed prior to and after LP-08 instillations at four and eight weeks follow-up visits
详细描述
This is a single-center, dose-ranging, placebo-controlled, double-blind, randomized study including male and female subjects with interstitial cystitis/bladder pain syndrome (IC/BPS) as determined by a physician using the current diagnostic criteria for IC/BPS. A total of 36 subjects will be enrolled at up to five (5) study sites in the U.S. Enrollment is expected to be completed within one year of initiating the study. The study is comprised of two parts. The first part of the study is a dose-ranging, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of LP-08 at 20 mg and 80 mg doses as compared with placebo. The second part of the study is an Open Label Extension study of the safety, tolerability and efficacy of LP-08 80 mg. Subjects randomized to the placebo control group must have completed the randomized portion study, including the eight week follow-up period, to be eligible for the Open Label Extension.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient is deemed suitable for inclusion in the study if the patient meets the following criteria:
- •Male or female at least 18 years of age
- •IC/BPS diagnosed by a health care provider based the following criteria:
- •Complaint of suprapubic pain related to bladder filling, accompanied by other symptoms such as increased daytime and night time frequency, in the absence of proven urinary infection or other obvious pathology Have had IC/BPS symptoms for at least six months Score of ≥ 12 on the ICSI/PI at baseline Urinary frequency > 10 times a day by self-report and confirmed on baseline three-day voiding diary Have IC/BPS that in the judgment of the investigator has been stable in the previous 30 days IC/BPS-related pain defined as a score of > 3 cm and < 9 cm on the pain VAS where 0 is no pain and 10 is maximum pain
- •Have had inadequate clinical responses with conservative treatments, which may include one or more of the following: 1) timed voiding and behavioral modification therapy, 2) dietary restrictions, 3) stress reduction and/or 5) oral therapy with any of the following medications:
- •Antidepressants Antihistamines Antimuscarinic and anticholinergic agents Alpha adrenergic blockers Analgesics Pentosan polysulfate
- •Women of childbearing potential: have a negative urine pregnancy test at screening, and must agree to use an acceptable from of contraception (oral contraceptives, intrauterine or double barrier methods), as agreed to by the investigator, during the study period
- •Provide signed informed consent
- •Subject agrees to be available for the follow-up evaluations as required by the protocol
排除标准
- •Patients are excluded from enrollment in the study if any of the following are true:
- •Currently pregnant or breastfeeding, or plan to become pregnant during the course of the study
- •Have received investigational products or devices within 30 days prior to screening visit
- •Have received intravesical therapy or bladder hydrodistention within 30 days prior to screening visit. Intravesical instillations may include liquid or drug delivery devices, pentosan polysulfate sodium, lidocaine, steroid, heparin, chondroitin and any combination or additional formulation.
- •Have participated in IC/BPS research trial within 90 days prior to screening visit or has not returned to baseline if participated in IC/BPS research trial greater than 90 days prior to screening visit
- •Have received any of the following medication within 30 days of screening visit, unless such medications have been administered at a stable dose during this month and are expected to remain at a stable dose throughout the study:
- •Antidepressants Antihistamines (use of antihistamines as needed for allergies is allowed) Anticonvulsants Antimuscarinic and anticholinergic agents Alpha adrenergic blockers Pentosan polysulfate sodium Oral chondroitin
- •Have indicated use of > 70 mg of morphine equivalents of opioids per week to control their IC/BPS pain within 30 days prior to screening, or are expected to require this level of IC/BPS pain control during the study period
- •Previous augmentation cystoplasty, cystectomy, neurectomy (i.e., hypogastric nerve plexus ablation). Bladder botulinum toxin injections within nine months prior to screening.
- •Sacral and/or pudendal nerve neuromodulation device (Interstim) within the last 6 months. Subjects would not be excluded if they had Interstim greater than 6 months ago and is on a stable setting within the past 90 days
- •Percutaneous Tibial Nerve Stimulation (PTNS) treatment within the past 90 days
- •Evidence of renal impairment (creatinine > two times the upper limit of normal at Visit 1), hepatic impairment (AST or ALT > three times the upper limit of normal at Visit 1), clinically significant cardiovascular, respiratory, or psychiatric diseases per investigator's judgment
- •Post-void residual (PVR) urine volume of > 150 mL at screening
- •Any condition that in the judgment of the investigator would interfere with the patient's ability to provide informed consent, comply with study instructions, place the patient at increased risk, or which might confound the interpretation of the study results
- •Previously received intravesical liposomes
- •Urinary tract or prostatic infection in the past 90 days before study entry
- •Active genital herpes or vaginitis
- •Urethral diverticulum
- •Pelvic malignancy within the past five years
- •History of cyclophosphamide or chemical cystitis, or tuberculosis or pelvic radiation
- •History of bladder or prostate tumors (benign or malignant)
- •Uncontrolled diabetes
- •Has any condition that would preclude treatment due to contraindications and/or warnings in the product labeling
研究组 & 干预措施
LP-08 80mg
4 weekly intravesical administration of LP-08 80mg
干预措施: LP-08 80mg (Drug)
LP-08 20mg
4 weekly intravesical administration of LP-08 20mg
干预措施: LP-08 20mg (Drug)
Normal Saline
Four weekly normal saline intravesical administration
干预措施: Normal saline (Drug)
结局指标
主要结局
Safety of Intravesical LP08: number/severity of adverse events
时间窗: Up to 31 weeks following treatment
The number/severity of adverse events throughout the study
次要结局
- Efficacy Global Response Assessment (GRA)(4, 8, 16, 24 weeks following treatment)
- Efficacy Voids Per Day (VPD)(2, 4, 8, 16, 24 weeks following treatment)
- Efficacy Visual Analog Scale (VAS)(2, 4, 8, 16, 24 weeks following treatment)
- Efficacy Symptom(2, 4, 8, 16, 24 weeks following treatment)
- Efficacy Diary(2, 4, 8, 16, 24 weeks following treatment)