A Randomized Study Comparing Placebo and ASP3652 in the Treatment of Women With Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01613586
• Date of registration: 05/06/2012
• Prospective Registration: No
• Primary sponsor: Astellas Pharma Europe B.V.
• Public title: A Randomized Study Comparing Placebo and ASP3652 in the Treatment of Women With Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC) AMARANTH
• Scientific title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Adaptive, Combined Proof of Concept and Dose-Finding Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the Treatment of Female Patients With Bladder Pain Syndrome / Interstitial Cystitis
• Date of first enrolment: May 31, 2012
• Target sample size: 287
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01613586
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belgium, Czech Republic, Czechia, Denmark, Germany, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russian Federation, Spain

Contacts

• Name: Clinical Study Manager
• Affiliation: Astellas Pharma Europe B.V.

Key inclusion & exclusion criteria

Inclusion Criteria:

- Has previously been diagnosed with BPS/IC; i.e., 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 3 months
prior to screening in absence of urinary infection or other obvious pathology or
identifiable causes

- Has at enrolment a score of 4 or greater on the 11-point (0-10) NRS for average pain
over the previous week, which is item 4 of the F-GUPI

- Has a mean pain score of 4.0 or greater on the 11-point (0-10) NRS for daily assessed
pain (item 4 of F-GUPI-24H) over the last 7 days prior to randomization

- Is willing to comply with study requirements such as completing the questionnaires and
diaries and attend all study visits and practicing birth control

Exclusion Criteria:

- Undergone a cystoscopy with hydrodistension or undergone Botox injections in the
bladder within 6 months prior to screening

- Use of pentosan polysulphate sodium within 4 weeks prior to screening

- Any intravesicular pharmacological treatment or other interventions for BPS/IC or
bladder, urethral, ureteral, pelvic or peri-pelvic invasive procedure within 3 months
prior to screening

- Cystitis or documented symptomatic bacterial cystitis in the last 3 months prior to
screening

- Lower urinary tract malignancy, such as positive (micro) hematuria in urine sediment

- Neurologic disease or defect affecting bladder function or symptomatic urethral
diverticulum or any post-partum or surgery related genital tract conditions,
symptomatic bladder or ureteral calculi or Post Void Residual volume greater than 150
mL

- Clinically significant abnormalities observed during cystoscopy or on transabdominal
ultrasound

- Currently active or treated sexual transmittable diseases

- Substance abuse or any use of delta-9-tertrahydrocannabinol (THC) as assessed by a
positive urine test for THC at screening

- Any clinically relevant concomitant disease (past or present) which would, in the
opinion of the investigator, put the subject at risk or mask measures of efficacy

- Symptoms of depression, defined as a Center for Epidemiological Studies Depression
Scale score of 27 or more

- Use of steroids, immunomodulators, cytochrome P4502C8 inhibitors, cannabis / THC based
medication, opioid analgesics or antiviral / antibacterial / antifungal agents during
the last 4 weeks before the screening

- Initiation, discontinuation, or variation in the dose of antidepressants,
anticonvulsants, antimuscarinics, benzodiazepines, skeletal muscle relaxants,
non-steroid anti-inflammatory drugs, non opioid analgesics, homeopathic medication and
herbal therapies during the last 4 weeks before the screening. Subjects should
continue these medications at that same stable dose throughout the study

- Clinically relevant abnormal urine or blood safety laboratory values or active hepatic
and/or biliary disease (AST or ALT should not be >2 times the upper limit of normal,
total bilirubin should not be >1.5 times the upper limit of normal)

- Participated in any clinical study or has been treated with any investigational drug
or device within 84 days or the period stipulated by local regulations, whichever is
longer, prior to the screening



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Urinary Bladder Disease

Cystitis, Interstitial

Pain

Urologic Diseases

Intervention(s)

Drug: Placebo

Drug: ASP3652

Primary Outcome(s)

Change from baseline in Mean Daily Pain (MDP) at 12 weeks [Time Frame: Baseline and 12 weeks]

Secondary Outcome(s)

Change from baseline in F-GUPI Pain subscale score, Urinary subscale score, and Quality of Life Impact score at 4, 8, 12 weeks treatment and at 2 weeks follow-up post treatment [Time Frame: Baseline, 4, 8, 12 weeks treatment and at 2 weeks follow-up post treatment]

Change from baseline in Voiding parameters (urinary frequency, urinary urgency, nocturia and total urgency score ) at 4, 8, 12 weeks treatment and at 2 weeks Follow-up post treatment [Time Frame: Baseline, 4, 8, 12 weeks treatment and 2 weeks follow-up post treatment]

Change from baseline in questionnaires (Center for Epidemiologic Studies Depression Scale and Profile of Mood States questionnaire) at 12 weeks treatment [Time Frame: Baseline and 12 weeks treatment]

Assessment of pharmacokinetics at week 4, 8 and 12 [Time Frame: 4, 8 and 12 weeks treatment]

Proportion of responders: at least 7-point decrease in F-GUPI Total score at 0, 4, 8 and 12 weeks treatment compared to baseline [Time Frame: Baseline, 4, 8 and 12 weeks treatment]

Assessment of pharmacodynamics at week 4, 8 and 12 [Time Frame: 4, 8 and 12 weeks treatment]

Global Response Assessment (GRA) at 0, 4, 8 and 12 weeks treatment and at 2 weeks follow-up post treatment [Time Frame: Baseline, 4, 8, 12 weeks treatment and 2 weeks follow-up post treatment]

Safety as assessed by recording Adverse Events, Laboratory tests, electrocardiograms (ECGs) and vital signs [Time Frame: Baseline and 12 weeks treatment]

Change from baseline in questionnaires at 12 weeks treatment [Time Frame: Baseline and 12 weeks treatment]

Safety as assessed by SteatoTest, adiponectin and PVR [Time Frame: Baseline and 12 weeks]

Change from baseline in Mean Daily Pain (MDP) at 4, 8 weeks treatment and at 2 weeks follow-up post treatment [Time Frame: Baseline, 4 and 8 weeks treatment and 2 weeks follow-up post treatment]

Change from baseline in Female GenitoUrinary Pain Index (one week recall) (F-GUPI) Total score at 4, 8, 12 weeks treatment and at 2 weeks follow-up post treatment [Time Frame: Baseline, 4, 8, 12 weeks treatment and 2 weeks follow-up post treatment]

Daily pain, assessed with item 4 of the F-GUPI-24h during Run-in, Treatment period and Follow-up post treatment [Time Frame: Every day during the Run-in, Treatment and Follow-up post treatment periods]

Physician Withdrawal Checklist at 12 weeks treatment and at 2 weeks follow-up post treatment [Time Frame: 12 weeks treatment and 2 weeks follow-up post treatment]

Secondary ID(s)

2011-004555-39

3652-CL-0018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors