NL-OMON45673已完成2 期
A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-group, Proof of Concept Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects with Bladder Pain Syndrome/Interstitial Cystitis - Serenity 6294-CL-0101
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •At Screening (Visit 1)
- •* The subject is female and at least 18 years of age.
- •* The subject*s signs, symptoms and diagnostic work-up are in accordance with the ESSIC definition for BPS/IC: pelvic pain, pressure or discomfort perceived to be related to the urinary bladder accompanied by at least one other urinary symptom such as persistent urge to void or frequency, for at least 6 months in absence of urinary infection or other obvious pathology or identifiable causes.
- •The subject has undergone at least two different therapies for BPS/IC with unsatisfactory results, prior to study entry.
- •* There is documented proof of the diagnosis BPS/IC that has been entered into the subject*s records at least 2 months prior to Visit 1/Screening.
- •* The subject has a score of * 4 and * 9 for pain as assessed by scoring the average pain of the week preceding Visit 1/Screening, using an 11-point NRS (0-10).
- •* The subject has an estimated voiding frequency of * 8 and * 30 voids per 24 hours.
- •* The subject has a score of * 7 on the ICSI questionnaire
- •* The subject must agree not to breastfeed starting at screening and throughout the study period, and for 5 half-lives (i.e., 70 days) after the final study drug administration at Visit 5/Week 8.
- •* The subject must agree not donate ova starting at screening and throughout the study period, and for 5 half-lives (i.e., 70 days) after the final study drug administration at Visit 5/Week 8.
- •* The subject must be willing and able to comply with study requirements (e.g., complete questionnaires and diaries, able to read and attend all required study visits).
- •* The subject agrees not to participate in another interventional study while participating in the present study (i.e., between Visit 1/Screening and Visit 7/Week 18).;At randomization (Visit 2/Baseline)
- •* The subject has at least moderate pain as reflected by an average MDP of * 4.0 and * 9.0. The average MDP is the average of daily assessments of MDP in the week prior to the visit with at least 5 recordings. Additionally, the MDP recordings must not differ over 4 points between consecutive days.
- •* The subject has a mean voiding frequency of * 8.0 and * 30.0 per 24 hours as assessed with the 3day electronic micturition diary in the week prior to the visit.
- •* The subject is confirmed to be willing to comply and has shown to be compliant with all study requirements during the run-in period.
排除标准
- •At Screening (Visit 1)
- •* The subject has osteoarthritis or has a history of rapidly progressive osteoarthritis.
- •* The subject has a score of * 30 on the Pain Catastrophizing Scale (PCS).
- •* The subject has a score of > 12 on the HADS-D (Hospital Anxiety and Depression Scale - Depression subscale).
- •* The subject has significant pelvic floor pain or spasm which is considered the main cause of the chronic pelvic/bladder pain as concluded by the investigator based on the pelvic floor examination.
- •* The subject has undergone a fulguration or excision of a Hunner*s lesion any time prior to the screening visit.
- •* The subject has recently undergone or started treatment for BPS/IC as specified below:
- •* subject has undergone a cystoscopy with hydrodistension or Botox injections in the bladder within 6 months prior to the screening visit.
- •* subject has received non-pharmacological interventions for BPS/IC (including but not limited to electric stimulation therapy or acupuncture therapy) within 3 months prior to the screening visit.
- •* subject has received any intravesical pharmacological treatment for BPS/IC (including but not limited to heparin or dimethyl sulfoxide) within 4 weeks prior to the screening visit
- •* subject had an initiation, discontinuation, or variation in the dose and/or frequency of antimuscarinics, mirabegron, antidepressants (including amitriptyline), anticonvulsants, benzodiazepines, skeletal muscle relaxants, nonsteroidal anti-inflammatory drugs, non opioid analgesics, pentosan polysulphate sodium, homeopathic medication and/or herbal therapies during the last 4 weeks prior to the screening visit.
- •* subject has had changes in non-pharmacological treatment for BPS/IC (e.g., diet or physical therapy) during the last 4 weeks prior to the screening visit.
- •* The subject has bladder pathology as specified below:
- •* a post-void residual (PVR) >200 mL.
- •* subject has a known currently symptomatic urethral diverticulum.
- •* subject has genital tract condition or pelvic pathology (e.g., post-partum, post-pelvic surgery, post-hysterectomy) that may complicate diagnosis and the evaluation of pelvic pain and urinary symptoms. Note: A history of a Cesarean section is not a reason for exclusion.
- •* subject has a known currently symptomatic bladder or ureteral calculi.
- •* subject currently has cystitis (radiation cystitis, Bacillus Calmette-Guérin-induced cystitis, bacterial/tuberculous cystitis, cyclophosphamide cystitis) or has had a documented symptomatic bacterial cystitis within the last 1 month prior to the screening visit.* In case of bacterial cystitis (UTI), the subject can be re-screened 1 month after successful treatment.
- •* subject has currently clinically significant urinary bladder abnormalities (e.g., bladder mass, bladder stone, bladder diverticulum, small contracted end-stage bladder), except for abnormalities associated with BPS/IC.
- •* subject has had any invasive procedures of either the urinary bladder, urethra, ureter or renal pelvis (e.g., transurethral resection of bladder [including bladder biopsy], urethral dilatation, endovesicular lithotripsy) within 3 months prior to the screening visit.
- •* subject has a known current neurologic disease or a defect affecting urinary bladder function (e.g., neurogenic bladder, systemic or central neurological disease, such as Multiple Sclerosis or Parkinson*s disease).
- •* subject has a known current lower ur
研究者
相似试验
进行中（未招募）
1 期
A study to assess if a new antiviral drug called FF-3 is safe and can protect healthy volunteers against infection with a type of flu virus.EUCTR2015-001103-31-GBAutoimmune Technologies, LLC79
进行中（未招募）
1 期
Study of the effect of ASP6294 for the treatment of Bladder Pain Syndrome/Interstitial Cystitis in female subjects.Bladder Pain Syndrome/Interstitial Cystitis (BPC/IC)MedDRA version: 20.0 Level: LLT Classification code 10071166 Term: Bladder pain syndrome System Organ Class: 100000004857EUCTR2016-004138-12-BEAstellas Pharma Europe B.V.163
进行中（未招募）
不适用
A Phase 2a, Randomized, Double-blind, Placebo-controlled, Parallel-arm, Multicenter Study to Evaluate the Efficacy and Safety of CAT-354, a Fully Human Monoclonal Antibody Directed Against Interleukin-13 (IL-13), on Asthma Control in Adults with Uncontrolled, Moderate-to-severe, Persistent AsthmaAsthmaEUCTR2008-007844-33-GBMedImmune Limited192
进行中（未招募）
1 期
Study of the effect of ASP6294 for the treatment of Bladder Pain Syndrome/Interstitial Cystitis in female subjects.Bladder Pain Syndrome/Interstitial Cystitis (BPC/IC)MedDRA version: 20.0 Level: LLT Classification code 10071166 Term: Bladder pain syndrome System Organ Class: 100000004857EUCTR2016-004138-12-NLAstellas Pharma Europe B.V.163
进行中（未招募）
1 期
A clinical study to evaluate safety, tolerability, Pharmacokinetics and Pharmacodynamis of Belcesiran in patients with PiZZ Alpha-1 Antitrypsin Deficiency.PiZZAlpha-1 Antitrypsin Deficiency Associated Liver DiseaseMedDRA version: 23.1Level: LLTClassification code 10001806Term: Alpha-1 anti-trypsin deficiencySystem Organ Class: 100000004850EUCTR2020-003313-35-ESDicerna Pharmaceuticals, Inc.54