The purpose of this study is to investigate efficacy, safety and tolerability of ASP6294 in female participants with Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC). This study will also investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of ASP6294 in female participants with BPS/IC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
119
Site BE32001
Leuven, Belgium
Site CZ42002
Pilsen, Czechia
Change from Baseline in Average Mean Daily Pain (MDP) Score at Week 12
Participants will record their MDP each day in the evening into an e-diary. The MDP is the average pain experienced over the past 24 hours. The average MDP is the mean of daily assessments of MDP in the week prior to the visit with at least 5 recordings in that week. MDP is measured using an 11-point Numerical Rating Scale (NRS) ranging from 0 (no bladder pain) to 10 (worst imaginable bladder pain). A negative change indicates a reduction/improvement from baseline.
Time frame: Baseline and Week 12
Change from Baseline in Average Worst Daily Pain (WDP) Score at Week 12
Participants will record their WDP each day in the evening into an e-diary. The WDP is the worst pain experienced over the past 24 hours. The average WDP is the mean of daily assessments of WDP in the week prior to the visit with at least 5 recordings in that week. WDP is measured using an 11-point NRS ranging from 0 (no bladder pain) to 10 (worst imaginable bladder pain). A negative change indicates a reduction/improvement from baseline.
Time frame: Baseline and Week 12
Change From Baseline in Mean Voiding Frequency per 24 hours at Week 12
Mean voiding frequency is the mean of the recordings of voiding frequency in the electronic micturition diary in the week prior to the visit with at least 2 days recorded in that week. A negative change indicates a reduction/improvement from baseline.
Time frame: Baseline and 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
The perceived level of urinary urgency is measured using PPIUS. For each micturition episode, participant will be asked to rate the degree of associated urgency severity according to PPIUS. PPIUS is a 5-point categorical scale ranging from 0 to 4, where 0 = no urgency (participant felt no need to empty the bladder, but did so for other reasons), 1 = mild urgency (participant could postpone voiding as long as necessary, without fear of wetting herself), 2 = moderate urgency (participant could postpone voiding for a short while, without fear of wetting herself), 3 = severe urgency (participant could not postpone voiding, had to rush to the toilet in order not to wet herself), and 4 = urge incontinence (participant leaked before arriving to the toilet). Mean number of Level 3 or 4 urgency episodes is the mean of recordings of Level 3 or 4 urgency episodes in 3-day electronic micturition diary in the week prior to visit.
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Site DE49003
Duisburg, Germany
Site DE49007
Duisburg, Germany
Site DE49001
Holzminden, Germany
Site DE49005
Markkleeberg, Germany
Site HU36002
Budapest, Hungary
Site HU36001
Csongrád, Hungary
Site LV37103
Daugavpils, Latvia
Site LV37101
Riga, Latvia
...and 18 more locations
Time frame: Baseline and Week 12
Change From Baseline in Bladder Pain/ Interstitial Cystitis Symptom Score (BPIC-SS) Total Score at Week 12
The BPIC-SS is a psychometrically validated and reliable questionnaire with 8 questions concerning bladder pain over the previous 7 days. Question (Q) 1 to Q5 assess urinary symptoms (how often urinated because of pain, need to urinate just after previous urination, urination to avoid pain, pressure in the bladder, and pain in the bladder) and are rated 0 (never) to 4 (always). Q6 and Q7 assess the impact of bladder pain (bothered by frequent urination during daytime and nighttime) and are rated 0 (not at all) to 4 (a great deal). Q8 assesses the worst pain on a 0 (no bladder pain) to 10 (worst possible bladder pain) NRS. The BPIC-SS total score is the sum of the individual question scores and range from 0 to 38, with higher scores indicating a worse situation. A score of 19 or more represents moderate/severe disease activity. A negative change indicates a reduction/improvement from baseline.
Time frame: Baseline and Week 12
Change From Baseline in BPIC-SS Worst Bladder Pain (Question 8) Score at Week 12
The BPIC-SS is a psychometrically validated and reliable questionnaire with 8 questions concerning bladder pain over the previous 7 days. Q8 of BPIC-SS assesses the worst pain on a 0 (no bladder pain) to 10 (worst possible bladder pain) NRS. A negative change indicates a reduction/improvement from baseline.
Time frame: Baseline and Week 12
Percentage of Participants With Moderately Improved or Better Grade on the Global Response Assessment (GRA) at Week 12
A self-reported 7 grade GRA is used to evaluate a participant's clinical condition relative to baseline. The GRA reads: As compared to when the participant started the study, how would the participant rate the participant's overall symptoms now? The 7 GRA grades are "markedly worse", "moderately worse", "slightly worse", "no change", "slightly improved", "moderately improved" or "markedly improved". Percentage of participants with a successful GRA response (defined as the response of "moderately improved" or better \["markedly improved"\] will be reported.
Time frame: Week 12