Study of the effect of ASP6294 for the treatment of Bladder Pain Syndrome/Interstitial Cystitis in female subjects.
- Conditions
- Bladder Pain Syndrome/Interstitial Cystitis (BPC/IC)MedDRA version: 20.0Level: LLTClassification code 10071166Term: Bladder pain syndromeSystem Organ Class: 100000017419Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2016-004138-12-ES
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 163
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.
14. Subject has a mean voiding frequency of = 8.0 and = 30.0 per 24 hours as assessed with the 3 day electronic micturition diary in the week prior to the visit.
15. Subject is confirmed to be willing to comply and has shown to be compliant with all study requirements during the run-in period.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years
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 within 6 months prior to screening assessment or breast feeding within 3 months prior to screening.
12.Subject has a known history of an allergic or anaphylactic reaction to biological drugs.
13.Subject has received a biological drug during the last 6 months prior to the screening visit.
14.Subject has a known history of hepatitis B or, C or of human immunodeficiency virus (HIV) infection.
15.Subject has a known history
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To investigate efficacy of ASP6294 in female subjects with Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC).<br>2. To investigate safety and tolerability of ASP6294 in female subjects with BPS/IC.<br>3. To investigate the pharmacokinetics and pharmacodynamics of ASP6294 in female subjects with BPS/IC.;Secondary Objective: Not applicable;Primary end point(s): Primary efficacy<br>Change from baseline in average MDP at Visit 6/Week 12.;Timepoint(s) of evaluation of this end point: Visit 6/Week 12
- Secondary Outcome Measures
Name Time Method