Study Details

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A study to evaluate the Long-term Safety of Repeated QUTENZA Administration for Treatment of Pain Caused by Nerve Damage in Diabetic Patients

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.
NCT01478607

Astellas Study ID

The unique identification code given by the study sponsor.

E05-CL-3002

EudraCT ID

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

2009-016458-42

Follow Trial

Condition

Neuropathic Pain

Phase

These clinical trials are done to confirm that an experimental treatment helps participants who have a specific condition. These clinical trials often compare the experimental treatment to another treatment or, if appropriate, a placebo.

Phase 3

Age

18 Years - N/A

Sex

Female & Male

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

Nov 2011 - Feb 2014

Masking

Single (Outcomes Assessor)

Enrollment number

468

A Randomized, Controlled, Long-term Safety Study Evaluating the Effect of Repeated Applications of QUTENZATM plus Standard of Care versus Standard of Care alone in Subjects with Painful Diabetic Peripheral Neuropathy

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: 601

Bonheiden, Belgium, 2820

Site: 603

Reet, Belgium, 2840

Site: 903

Beroun, Czech Republic, 26601

Site: 910

Brno, Czech Republic, 60200

Site: 908

Chocen, Czech Republic, 56501

Site: 907

Hodonin, Czech Republic, 69501

Site: 911

Litomerice, Czech Republic, 41201

Site: 905

Ostrava, Czech Republic, 70200

Site: 906

Ostrava, Czech Republic, 71000

Site: 904

Policka, Czech Republic, 57201

Site: 901

Praha 4, Czech Republic, 14000

Site: 902

Prerov, Czech Republic, 75003

Site: 909

Rychnov nad Kneznou, Czech Republic, 51601

Site: 207

Bron, France, 69677

Site: 202

Paris, France, 75004

Site: 201

Pierre Benite, France, 69495

Site: 206

Toulouse, France, 31059

Site: 511

Bad Lauterberg, Germany, 37431

Site: 508

Chiemsee, Germany, 83209

Site: 502

Dresden, Germany, 1307

Site: 501

Falkensee, Germany, 14612

Site: 514

Frankfurt, Germany, 60311

Site: 507

Hamburg, Germany, 22177

Site: 509

Koln, Germany, 50937

Site: 505

Leipzig, Germany, 04109

Site: 506

Muenster, Germany, 48145

Site: 504

Regensburg, Germany, 93053

Site: 512

Wangen, Germany, 88239

Site: 404

Milano, Italy, 20162

Site: 407

Milano, Italy, 20159

Site: 401

Roma, Italy, 00133

Site: 403

Roma, Italy, 00133

Site: 651

Utrecht, Netherlands, 3584 CX

Site: 652

Utrecht, Netherlands, 2333 ZA

Site: 965

Bialystok, Poland, 15435

Site: 961

Bydgoszcz, Poland, 85822

Site: 957

Elblag, Poland, 82300

Site: 958

Gdynia, Poland, 81049

Site: 954

Katowice, Poland, 40954

Site: 964

Krakow, Poland, 31530

Site: 951

Lodz, Poland, 90153

Site: 966

Lubin, Poland, 59300

Site: 953

Poznan, Poland, 61655

Site: 959

Torun, Poland, 87100

Site: 960

Warszawa, Poland, 1868

Site: 963

Warszawa, Poland, 02256

Site: 714

Kemerovo, Russian Federation, 150062

Site: 707

Moscow, Russian Federation, 79117778999

Site: 712

Nizhny Novgorod, Russian Federation, 79117778999

Site: 708

Samara, Russian Federation, 79117778999

Site: 709

Saratov, Russian Federation, 79117120826

Site: 701

St. Petersburg, Russian Federation, 79117120826

Site: 702

St. Petersburg, Russian Federation, 791177120826

Site: 703

St. Petersburg, Russian Federation, 191015

Site: 704

St. Petersburg, Russian Federation, 79117120826

Site: 706

St. Petersburg, Russian Federation, 79117778999

Site: 710

St. Petersburg, Russian Federation, 79117778999

Site: 716

St. Petersburg, Russian Federation, 194358

Site: 713

Tomsk, Russian Federation, 79117778999

Site: 711

Yaroslavl, Russian Federation, 79117778999

Site: 302

Cadiz, Spain, 11009

Site: 301

Toledo, Spain, 45004

Site: 303

Valencia, Spain, 46010

Site: 304

Valencia, Spain, 46014

Site: 305

Valladolid, Spain, 47012

Site: 808

Chernihiv, Ukraine, 14034

Site: 809

Dnipropetrovs'k, Ukraine, 49023

Site: 803

Kharkiv, Ukraine, 61037

Site: 812

Kvuv, Ukraine, 79010

Site: 805

Kyiv, Ukraine, 2091

Site: 806

Kyiv, Ukraine, 4114

Site: 807

Kyiv, Ukraine, 4053

Site: 810

Lviv, Ukraine, 79010

Site: 802

Mykolayiv, Ukraine, 54003

Site: 801

Odesa, Ukraine, 65009

Site: 804

Poltava, Ukraine, 36024

Site: 813

Vinnitsa, Ukraine, 21010

Site: 815

Zaporizhzhya, Ukraine, 69001

Site: 102

Chorley, United Kingdom, PR7 1PP

Site: 103

Liverpool, United Kingdom, L7 8XP

Site: 104

Poole, United Kingdom, BH15 2JB

Site: 101

Rugby, United Kingdom, CV22 5PX

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