Study Details

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A Randomized Study comparing Placebo and ASP3652 in the treatment of women with Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC)

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01613586

Astellas Study ID

The unique identification code given by the study sponsor.

3652-CL-0018

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

2011-004555-39

Follow Trial

Condition

Bladder Disease, Pain

Phase

These clinical trials are done to learn if an experimental treatment helps participants who have a specific condition or disease. Phase 2 trials usually include a larger group of participants than Phase 1 trials.

Phase 2

Age

18 years - N/A

Sex

Female

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

May 2012 - Mar 2014

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number

287

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 summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site: 6301

Vilnius, Lithuania, 09108

Site: 5302

Naestved, Denmark, 4700

Site 6202

Laguna, Spain, 38330

Site 5901

Porto, Portugal, 4200-319

Site 6002

Bucharest, Romania, 042122

Site 6203

Barcelona, Spain, 08024

Site: 5805

Piaseczno, Poland, 05-500

Site: 6302

Vilnius, Lithuania, 08661

Site: 5803

Warsaw, Poland, 02-784

Site: 5402

Holzminden, Germany, 37603

Site: 5601

Riga, Latvia, 1002

Site 6101

Moscow, Russian Federation, 127473

Site: 5603

Riga, Latvia, 1038

Site 6005

Iasi, Romania, 700503

Site: 5602

Liepaja, Latvia, 3401

Site 6006

Brasov, Romania, 500152

Site: 5802

Warsaw, Poland, 00-865

Site 5806

Bydgoszcz, Poland, 85-094

Site: 5203

Kromeriz, Czech Republic, 767 55

Site 6103

Moscow, Russian Federation, 105425

Site: 6303

Vilnius, Lithuania, 10207

Site: 5702

Winterswijk, Netherlands, 7101 BN

Site: 5409

Frankfurt am Main, Germany, 60590

Site 6204

Malaga, Spain, 29009

Site 6108

Moscow, Russian Federation, 101000

Site 6109

Moscow, Russian Federation, 123995

Site: 5301

Herlev, Denmark, 2730

Site: 5303

Aarhus, Denmark, 8200

Site 5903

Porto, Portugal, 4099-001

Site: 5801

Lodz, Poland, 90-447

Site 5902

Coimbra, Portugal, 3000-075

Site 6004

Bucharest, Romania, 021392

Site 6107

Tomsk, Russian Federation, 634063

Site: 5405

Mainz, Germany, 55131

Site 6104

Moscow, Russian Federation, 105425

Site 6003

Bucharest, Romania, 0100-000

Site: 6111

Moscow, Russian Federation, 115682

Site: 5206

Olomouc, Czech Republic, 775 20

Site: 5407

Moenchengladbach, Germany, 41063

Site: 5812

Poznan, Poland, 61-397

Site: 5406

Duisburg, Germany, 47179

Site: 5414

Offenburg, Germany, 77654

Site 6105

Omsk, Russian Federation, 644013

Site: 5408

Reutlingen, Germany, 72764

Site: 5202

Kralove, Czech Republic, 500 05

Site: 5403

Emmendingen, Germany, 79312

Site: 5811

Chorzow, Poland, 41-500

Site: 5705

Gouda, Netherlands, 2803 HH

Site: 5210

Sternberk, Czech Republic, 785 01

Site: 5209

Plzen, Czech Republic, 301 00

Site: 5807

Bialystok, Poland, 15-224

Site 5105

Brussels, Belgium, 1000

Site: 5104

Kortrijk, Belgium, 8500

Site: 5703

Maastricht, Netherlands, 6229 HX

Site: 5704

Zwijndrecht, Netherlands, 3331 LZ

Site: 5401

Herne, Germany, 44627

Site 6201

Barcelona, Spain, 08850

Site: 5103

Brussels, Belgium, 1070

Site 6007

Bucharest, Romania, 022328

Site 6001

Targu Mures, Romania, 540103

Site: 5804

Warsaw, Poland, 01-432

Site: 5101

Antwerp, Belgium, 2650

Site: 5207

Usti nad Labem, Czech Republic, 401 13

Site: 5706

Amsterdam, Netherlands, 1081HV

Site: 5201

Uherske Hradiste, Czech Republic, 686 68

Site: 5208

Jablonec nad Nisou, Czech Republic, 466 60

Site: 5701

Nijmegen, Netherlands, 6525 GA

Site 6102

St.-Petersburg, Russian Federation, 197022

Site: 5102

Gent, Belgium, 9000

Site 6110

Rostov-on-Don, Russian Federation, 344022

Site 6106

Moscow, Russian Federation, 117997

Site 5410

Kirchheim, Germany, 73270

Site: 6304

Kaunas, Lithuania, 50154

Site: 5404

Nurtingen, Germany, 72622

Site: 5205

Praha, Czech Republic, 121 08

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