EUCTR2016-004138-12-NL进行中（未招募）1 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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 163
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •At Screening (Visit 1)
- •1. Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
- •2. Subject is female and at least 18 years of age.
- •3. 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 1 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. 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.
- •4. 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).
- •5. Subject has an estimated voiding frequency of = 8 and = 30 voids per 24 hours.
- •6. Subject has a score of = 7 on the ICSI questionnaire.
- •7. The subject must either:
- •Be of nonchildbearing potential:
- •- Postmenopausal (defined as at least 1 year without any menses for which there is no other obvious pathological or physiological cause) prior to screening, or
- •- Documented surgically sterile
- •Or, if of childbearing potential,
- •- Agree not to try to become pregnant during the study and for 5 half-lives after the final study drug administration at Visit 5/Week 8, and
- •- Have a negative urine pregnancy test at Visit 1/Screening, and
- •- If heterosexually active, agree to consistently use 1 form of highly effective birth control starting at screening and throughout the study period and for 5 half-lives after the final study drug administration at Visit 5/Week 8. Highly effective birth control methods include established use of oral, injected or implanted hormonal methods of contraception, OR placement of an intrauterine device or intrauterine system.
- •8. Subjects must agree not to breastfeed starting at screening and throughout the study period, and for 5 half-lives after the final study drug administration at Visit 5/Week 8.
- •9. Subject must agree not to donate ova starting at screening and throughout the study period, and for 5 half-lives after the final study drug administration at Visit 5/Week 8.
- •10. Subject must be willing and able to comply with study requirements.
- •11. Subject agrees not to participate in another interventional study while participating in the present study.
- •12. The subject has undergone at least two different therapies for BPS/IC with unsatisfactory results, prior to study entry.
- •At randomization:
- •13. 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.
排除标准
- •1.Subject has osteoarthritis or has a history of rapidly progressive osteoarthritis.
- •2.Subject has a score of = 30 on the Pain Catastrophizing Scale.
- •3.Subject has a score of > 12 on the HADS-D (Hospital Anxiety and Depression Scale - Depression subscale).
- •4.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.
- •5.Subject has undergone a fulguration or excision of a Hunner’s lesion any time prior to the screening visit.
- •6.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 during the last 4 weeks prior to the screening visit.
- •7.Subject has bladder pathology as:
- •-post-void residual (PVR) >200 mL.
- •-known currently symptomatic urethral diverticulum.
- •-genital tract condition or pelvic pathology that may complicate diagnosis and the evaluation of pelvic pain and urinary symptoms.
- •-known currently symptomatic bladder or ureteral calculi.
- •-subject currently has 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 except for abnormalities associated with BPS/IC.
- •-subject has had any invasive procedures of either the urinary bladder, urethra, ureter or renal pelvis within 3 months prior to the screening visit.
- •-subject has a known current neurologic disease or a defect affecting urinary bladder function.
- •-subject has a known current lower urinary tract malignancy.
- •8.Subject has a known history of, or currently has inflammatory bowel disease and/or Sjögren Syndrome.
- •9.Subject has a known current severe constipation and/or severe diarrhea, severe active diverticulitis and/or severe gastrointestinal bleeding.
- •10.Subject has a known or suspected hypersensitivity to ASP6294 or any components of the formulation used.
- •11.Subject has been pregnant
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