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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03282318
Date of registration: 12/09/2017
Prospective Registration: Yes
Primary sponsor: Astellas Pharma Europe B.V.
Public title: A Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP6294 in the Treatment of Female Subjects With Bladder Pain Syndrome/Interstitial Cystitis SERENITY
Scientific title: 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
Date of first enrolment: September 28, 2017
Target sample size: 119
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT03282318
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).  
Phase:  Phase 2
Countries of recruitment
Belgium Czechia Germany Hungary Latvia Netherlands Poland Russian Federation
Spain United Kingdom
Contacts
Name:     Project Physician
Address: 
Telephone:
Email:
Affiliation:  Astellas Pharma Europe B.V.
Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject's signs, symptoms and diagnostic work-up are in accordance with the
international society for the study of bladder pain syndrome (ESSIC) definition for
bladder pain syndrome/interstitial cystitis (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.

- 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).

- Subject has an estimated voiding frequency of = 8 and = 30 voids per 24 hours.

- Subject has a score of = 7 on the interstitial cystitis symptom index (ICSI)
questionnaire.

- 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 (e.g., hysterectomy, bilateral salpingectomy,
bilateral oophorectomy)

- Or, if of childbearing potential,

- Agree not to try to become pregnant during the study and for 5 half-lives (i.e.,
70 days) 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 (i.e., 70 days) after the final study drug administration at Visit
5/Week 8.

- 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.

- Subject must agree not to 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.

- 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).

- 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).

- Subject has undergone at least 2 different therapies for BPS/IC with unsatisfactory
results, prior to study entry.

- 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.

- 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.

- Subject is confirmed to be willing to comply and has shown to be compliant with all
study requirements during the run-in period.

Exclusion Criteria:

- Subject has osteoarthritis or has a history of rapidly progressive osteoarthritis.

- Subject has a score of = 30 on the Pain Catastrophizing Scale (PCS).

- Subject has a score of > 12 on the HADS-D (Hospital Anxiety and Depression Scale -
Depression subscale).

- 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.

- Subject has undergone a fulguration or excision of a Hunner's lesion any time prior to
the screening visit.

- 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.

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Bladder Pain Syndrome
Interstitial Cystitis
Intervention(s)
Drug: Placebo
Drug: ASP6294
Primary Outcome(s)
Change from Baseline in Average Mean Daily Pain (MDP) Score at Week 12 [Time Frame: Baseline and Week 12]
Secondary Outcome(s)
Percentage of Participants With Moderately Improved or Better Grade on the Global Response Assessment (GRA) at Week 12 [Time Frame: Week 12]
Change From Baseline in Mean Number of Level 3 or 4 Urgency Episodes (Based on Patient Perception of Intensity of Urgency Scale [PPIUS]) per 24 hours at Week 12 [Time Frame: Baseline and Week 12]
Change From Baseline in Mean Voiding Frequency per 24 hours at Week 12 [Time Frame: Baseline and Week 12]
Change From Baseline in Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) Total Score at Week 12 [Time Frame: Baseline and Week 12]
Change from Baseline in Average Worst Daily Pain (WDP) Score at Week 12 [Time Frame: Baseline and Week 12]
Change From Baseline in BPIC-SS Worst Bladder Pain (Question 8) Score at Week 12 [Time Frame: Baseline and Week 12]
Secondary ID(s)
2016-004138-12
6294-CL-0101
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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