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

Primary Purpose

Cystitis, Interstitial, Urinary Bladder Disease, Pain

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ASP3652
Placebo
Sponsored by
Astellas Pharma Europe B.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystitis, Interstitial focused on measuring ASP3652, Painful Bladder Syndrome, Interstitial Cystitis, Bladder Pain Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Site: 5101
  • Site: 5103
  • Site: 5202
  • Site: 5203
  • Site: 5206
  • Site: 5209
  • Site: 5210
  • Site: 5201
  • Site: 5303
  • Site: 5301
  • Site: 5302
  • Site: 5406
  • Site: 5403
  • Site: 5409
  • Site: 5402
  • Site 5410
  • Site: 5405
  • Site: 5404
  • Site: 5414
  • Site: 5602
  • Site: 5601
  • Site: 5603
  • Site: 6304
  • Site: 6302
  • Site: 6301
  • Site: 6303
  • Site: 5706
  • Site: 5703
  • Site: 5701
  • Site: 5702
  • Site: 5704
  • Site: 5807
  • Site 5806
  • Site: 5811
  • Site: 5801
  • Site: 5805
  • Site: 5812
  • Site: 5802
  • Site: 5804
  • Site: 5803
  • Site 5902
  • Site 5903
  • Site 5901
  • Site 6006
  • Site 6003
  • Site 6004
  • Site 6007
  • Site 6002
  • Site 6005
  • Site 6001
  • Site 6108
  • Site 6103
  • Site: 6111
  • Site 6106
  • Site 6101
  • Site 6102
  • Site 6202
  • Site 6203
  • Site 6201
  • Site 6204

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Low dose ASP3652 twice daily

Medium dose ASP3652 twice daily

High dose ASP3652 twice daily

Placebo

Arm Description

50 mg twice daily for 12 weeks

150 mg twice daily for 12 weeks

300 mg twice daily for 12 weeks

Matching placebo twice daily for 12 weeks

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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
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
Daily pain, assessed with item 4 of the F-GUPI-24h during Run-in, Treatment period and Follow-up post treatment
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
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
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
Proportion of responders: at least 7-point decrease in F-GUPI Total score at 0, 4, 8 and 12 weeks treatment compared to baseline
Assessment of pharmacokinetics at week 4, 8 and 12
Plasma levels of ASP3652
Assessment of pharmacodynamics at week 4, 8 and 12
Plasma levels of anandamides
Safety as assessed by recording Adverse Events, Laboratory tests, electrocardiograms (ECGs) and vital signs
Safety as assessed by SteatoTest, adiponectin and PVR
Change from baseline in questionnaires (Center for Epidemiologic Studies Depression Scale and Profile of Mood States questionnaire) at 12 weeks treatment
Physician Withdrawal Checklist at 12 weeks treatment and at 2 weeks follow-up post treatment

Full Information

First Posted
June 5, 2012
Last Updated
January 15, 2019
Sponsor
Astellas Pharma Europe B.V.
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1. Study Identification

Unique Protocol Identification Number
NCT01613586
Brief Title
A Randomized Study Comparing Placebo and ASP3652 in the Treatment of Women With Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC)
Acronym
AMARANTH
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 31, 2012 (Actual)
Primary Completion Date
March 18, 2014 (Actual)
Study Completion Date
March 18, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Europe B.V.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystitis, Interstitial, Urinary Bladder Disease, Pain, Urologic Diseases
Keywords
ASP3652, Painful Bladder Syndrome, Interstitial Cystitis, Bladder Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
287 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose ASP3652 twice daily
Arm Type
Experimental
Arm Description
50 mg twice daily for 12 weeks
Arm Title
Medium dose ASP3652 twice daily
Arm Type
Experimental
Arm Description
150 mg twice daily for 12 weeks
Arm Title
High dose ASP3652 twice daily
Arm Type
Experimental
Arm Description
300 mg twice daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ASP3652
Intervention Description
Oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Change from baseline in Mean Daily Pain (MDP) at 12 weeks
Description
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)
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in Mean Daily Pain (MDP) at 4, 8 weeks treatment and at 2 weeks follow-up post treatment
Description
Pain is assessed on an 11 point (0-10) Numerical Rating Scale (NRS), which is item 4 of the F-GUPI-24h
Time Frame
Baseline, 4 and 8 weeks treatment and 2 weeks follow-up post treatment
Title
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
Title
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
Title
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
Title
Change from baseline in questionnaires at 12 weeks treatment
Description
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
Time Frame
Baseline and 12 weeks treatment
Title
Global Response Assessment (GRA) at 0, 4, 8 and 12 weeks treatment and at 2 weeks follow-up post treatment
Description
GRA is assessed as change from baseline which is here start of Run-in period
Time Frame
Baseline, 4, 8, 12 weeks treatment and 2 weeks follow-up post treatment
Title
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
Title
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
Title
Assessment of pharmacokinetics at week 4, 8 and 12
Description
Plasma levels of ASP3652
Time Frame
4, 8 and 12 weeks treatment
Title
Assessment of pharmacodynamics at week 4, 8 and 12
Description
Plasma levels of anandamides
Time Frame
4, 8 and 12 weeks treatment
Title
Safety as assessed by recording Adverse Events, Laboratory tests, electrocardiograms (ECGs) and vital signs
Time Frame
Baseline and 12 weeks treatment
Title
Safety as assessed by SteatoTest, adiponectin and PVR
Time Frame
Baseline and 12 weeks
Title
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
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Study Manager
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Director
Facility Information:
Facility Name
Site: 5101
City
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Site: 5103
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Site: 5202
City
Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Site: 5203
City
Kromeriz
ZIP/Postal Code
767 55
Country
Czechia
Facility Name
Site: 5206
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Site: 5209
City
Plzen
ZIP/Postal Code
301 00
Country
Czechia
Facility Name
Site: 5210
City
Sternberk
ZIP/Postal Code
785 01
Country
Czechia
Facility Name
Site: 5201
City
Uherske Hradiste
ZIP/Postal Code
686 68
Country
Czechia
Facility Name
Site: 5303
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Site: 5301
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Site: 5302
City
Naestved
ZIP/Postal Code
4700
Country
Denmark
Facility Name
Site: 5406
City
Duisburg
ZIP/Postal Code
47179
Country
Germany
Facility Name
Site: 5403
City
Emmendingen
ZIP/Postal Code
79312
Country
Germany
Facility Name
Site: 5409
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
Site: 5402
City
Holzminden
ZIP/Postal Code
37603
Country
Germany
Facility Name
Site 5410
City
Kirchheim
ZIP/Postal Code
73270
Country
Germany
Facility Name
Site: 5405
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Site: 5404
City
Nurtingen
ZIP/Postal Code
72622
Country
Germany
Facility Name
Site: 5414
City
Offenburg
ZIP/Postal Code
77654
Country
Germany
Facility Name
Site: 5602
City
Liepaja
ZIP/Postal Code
3401
Country
Latvia
Facility Name
Site: 5601
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Site: 5603
City
Riga
ZIP/Postal Code
1038
Country
Latvia
Facility Name
Site: 6304
City
Kaunas
ZIP/Postal Code
50154
Country
Lithuania
Facility Name
Site: 6302
City
Vilnius
ZIP/Postal Code
08661
Country
Lithuania
Facility Name
Site: 6301
City
Vilnius
ZIP/Postal Code
09108
Country
Lithuania
Facility Name
Site: 6303
City
Vilnius
ZIP/Postal Code
10207
Country
Lithuania
Facility Name
Site: 5706
City
Amsterdam
ZIP/Postal Code
1081HV
Country
Netherlands
Facility Name
Site: 5703
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Site: 5701
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Site: 5702
City
Winterswijk
ZIP/Postal Code
7101 BN
Country
Netherlands
Facility Name
Site: 5704
City
Zwijndrecht
ZIP/Postal Code
3331 LZ
Country
Netherlands
Facility Name
Site: 5807
City
Bialystok
ZIP/Postal Code
15-224
Country
Poland
Facility Name
Site 5806
City
Bydgoszcz
ZIP/Postal Code
85-094
Country
Poland
Facility Name
Site: 5811
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Site: 5801
City
Lodz
ZIP/Postal Code
90-447
Country
Poland
Facility Name
Site: 5805
City
Piaseczno
ZIP/Postal Code
05-500
Country
Poland
Facility Name
Site: 5812
City
Poznan
ZIP/Postal Code
61-397
Country
Poland
Facility Name
Site: 5802
City
Warsaw
ZIP/Postal Code
00-865
Country
Poland
Facility Name
Site: 5804
City
Warsaw
ZIP/Postal Code
01-432
Country
Poland
Facility Name
Site: 5803
City
Warsaw
ZIP/Postal Code
02-784
Country
Poland
Facility Name
Site 5902
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Site 5903
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Site 5901
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Site 6006
City
Brasov
ZIP/Postal Code
500152
Country
Romania
Facility Name
Site 6003
City
Bucharest
ZIP/Postal Code
0100-000
Country
Romania
Facility Name
Site 6004
City
Bucharest
ZIP/Postal Code
021392
Country
Romania
Facility Name
Site 6007
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Site 6002
City
Bucharest
ZIP/Postal Code
042122
Country
Romania
Facility Name
Site 6005
City
Iasi
ZIP/Postal Code
700503
Country
Romania
Facility Name
Site 6001
City
Targu Mures
ZIP/Postal Code
540103
Country
Romania
Facility Name
Site 6108
City
Moscow
ZIP/Postal Code
101000
Country
Russian Federation
Facility Name
Site 6103
City
Moscow
ZIP/Postal Code
105425
Country
Russian Federation
Facility Name
Site: 6111
City
Moscow
ZIP/Postal Code
115682
Country
Russian Federation
Facility Name
Site 6106
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
Site 6101
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
Site 6102
City
St.-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Site 6202
City
Laguna
State/Province
Tenerife
ZIP/Postal Code
38330
Country
Spain
Facility Name
Site 6203
City
Barcelona
ZIP/Postal Code
08024
Country
Spain
Facility Name
Site 6201
City
Barcelona
ZIP/Postal Code
08850
Country
Spain
Facility Name
Site 6204
City
Malaga
ZIP/Postal Code
29009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
IPD Sharing Time Frame
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
IPD Sharing Access Criteria
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
IPD Sharing URL
https://www.clinicalstudydatarequest.com/
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=287
Description
Link to results on the Astellas Clinical Study Results website

Learn more about this trial

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

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