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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01613586
Other study ID # 3652-CL-0018
Secondary ID 2011-004555-39
Status Completed
Phase Phase 2
First received
Last updated
Start date May 31, 2012
Est. completion date March 18, 2014

Study information

Verified date January 2019
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study several dose levels of ASP3652, given orally for 12 weeks, will be compared with placebo in the treatment of female patients with Bladder Pain Syndrome / Interstitial Cystitis.


Description:

This study consists of a screening phase, an initial 3 weeks Run-in period,

a 12 weeks Treatment period and a 2 weeks Follow-up (FU) period.

This study will investigate the efficacy and safety of a 12 week treatment with ASP3652 in female patients with Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC). Different dose levels of ASP3652 will be compared with placebo. ASP3652 is administered as oral tablets. The objectives of the study are to investigate efficacy of ASP3652 in patients with BPS/IC, to assess the optimal dose of ASP3652, to investigate safety and tolerability and to investigate pharmacokinetics and pharmacodynamics of ASP3652 in patients with BPS/IC in an out-patient setting.


Recruitment information / eligibility

Status Completed
Enrollment 287
Est. completion date March 18, 2014
Est. primary completion date March 18, 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
ASP3652
Oral
Placebo
Oral

Locations

Country Name City State
Belgium Site: 5101 Antwerp
Belgium Site: 5103 Brussels
Czechia Site: 5202 Kralove
Czechia Site: 5203 Kromeriz
Czechia Site: 5206 Olomouc
Czechia Site: 5209 Plzen
Czechia Site: 5210 Sternberk
Czechia Site: 5201 Uherske Hradiste
Denmark Site: 5303 Aarhus
Denmark Site: 5301 Herlev
Denmark Site: 5302 Naestved
Germany Site: 5406 Duisburg
Germany Site: 5403 Emmendingen
Germany Site: 5409 Frankfurt am Main
Germany Site: 5402 Holzminden
Germany Site 5410 Kirchheim
Germany Site: 5405 Mainz
Germany Site: 5404 Nurtingen
Germany Site: 5414 Offenburg
Latvia Site: 5602 Liepaja
Latvia Site: 5601 Riga
Latvia Site: 5603 Riga
Lithuania Site: 6304 Kaunas
Lithuania Site: 6301 Vilnius
Lithuania Site: 6302 Vilnius
Lithuania Site: 6303 Vilnius
Netherlands Site: 5706 Amsterdam
Netherlands Site: 5703 Maastricht
Netherlands Site: 5701 Nijmegen
Netherlands Site: 5702 Winterswijk
Netherlands Site: 5704 Zwijndrecht
Poland Site: 5807 Bialystok
Poland Site 5806 Bydgoszcz
Poland Site: 5811 Chorzow
Poland Site: 5801 Lodz
Poland Site: 5805 Piaseczno
Poland Site: 5812 Poznan
Poland Site: 5802 Warsaw
Poland Site: 5803 Warsaw
Poland Site: 5804 Warsaw
Portugal Site 5902 Coimbra
Portugal Site 5901 Porto
Portugal Site 5903 Porto
Romania Site 6006 Brasov
Romania Site 6002 Bucharest
Romania Site 6003 Bucharest
Romania Site 6004 Bucharest
Romania Site 6007 Bucharest
Romania Site 6005 Iasi
Romania Site 6001 Targu Mures
Russian Federation Site 6101 Moscow
Russian Federation Site 6103 Moscow
Russian Federation Site 6106 Moscow
Russian Federation Site 6108 Moscow
Russian Federation Site: 6111 Moscow
Russian Federation Site 6102 St.-Petersburg
Spain Site 6201 Barcelona
Spain Site 6203 Barcelona
Spain Site 6202 Laguna Tenerife
Spain Site 6204 Malaga

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in Mean Daily Pain (MDP) at 12 weeks Pain is assessed on an 11 point (0-10) Numerical Rating Scale (NRS), which is item 4 of the Female GenitoUrinary Pain Index (24 hours recall) (F-GUPI-24h) Baseline and 12 weeks
Secondary Change from baseline in Mean Daily Pain (MDP) at 4, 8 weeks treatment and at 2 weeks follow-up post treatment Pain is assessed on an 11 point (0-10) Numerical Rating Scale (NRS), which is item 4 of the F-GUPI-24h Baseline, 4 and 8 weeks treatment and 2 weeks follow-up post treatment
Secondary 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 Baseline, 4, 8, 12 weeks treatment and 2 weeks follow-up post treatment
Secondary 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 Baseline, 4, 8, 12 weeks treatment and at 2 weeks follow-up post treatment
Secondary Daily pain, assessed with item 4 of the F-GUPI-24h during Run-in, Treatment period and Follow-up post treatment Every day during the Run-in, Treatment and Follow-up post treatment periods
Secondary Change from baseline in questionnaires at 12 weeks treatment Bladder Pain/IC Symptom Score; O'Leary-Sant IC Symptom & Problem Index; Short form McGill pain questionnaire; Female Sexual Function Index; European Quality of Life questionnaire in 5 Dimensions Baseline and 12 weeks treatment
Secondary Global Response Assessment (GRA) at 0, 4, 8 and 12 weeks treatment and at 2 weeks follow-up post treatment GRA is assessed as change from baseline which is here start of Run-in period Baseline, 4, 8, 12 weeks treatment and 2 weeks follow-up post treatment
Secondary 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 Baseline, 4, 8, 12 weeks treatment and 2 weeks follow-up post treatment
Secondary Proportion of responders: at least 7-point decrease in F-GUPI Total score at 0, 4, 8 and 12 weeks treatment compared to baseline Baseline, 4, 8 and 12 weeks treatment
Secondary Assessment of pharmacokinetics at week 4, 8 and 12 Plasma levels of ASP3652 4, 8 and 12 weeks treatment
Secondary Assessment of pharmacodynamics at week 4, 8 and 12 Plasma levels of anandamides 4, 8 and 12 weeks treatment
Secondary Safety as assessed by recording Adverse Events, Laboratory tests, electrocardiograms (ECGs) and vital signs Baseline and 12 weeks treatment
Secondary Safety as assessed by SteatoTest, adiponectin and PVR Baseline and 12 weeks
Secondary Change from baseline in questionnaires (Center for Epidemiologic Studies Depression Scale and Profile of Mood States questionnaire) at 12 weeks treatment Baseline and 12 weeks treatment
Secondary Physician Withdrawal Checklist at 12 weeks treatment and at 2 weeks follow-up post treatment 12 weeks treatment and 2 weeks follow-up post treatment
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