Study Details

A study to compare QUTENZA with pregabalin for the treatment of peripheral neuropathic pain (PNP) after 8 weeks of treatment

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.
NCT01713426

Astellas Study ID

The unique identification code given by the study sponsor.

QTZ-EC-0004

EudraCT ID

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

2011-005872-41

Condition

Peripheral Pain, Shingles, Peripheral Nerve Injury

Phase

These clinical trials happen after a drug or treatment has been approved for patients to take. Clinical trials in phase 4 usually take place over many years because researchers want to learn about long term use and safety of a drug or treatment.

Phase 4

Age

18 years - 80 years

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

Jul 2012 - Sep 2013

Masking

None (Open Label)

Enrollment number

568

Qutenza versus pregabalin in subjects with peripheral neuropathic pain: an open-label, randomized, multicenter, non-inferiority efficacy and tolerability study

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 191 Med Zentr Städreg Aachen GmbH

Würselen, Germany, 52146

Site 332 Gartnavel General Hospital

Glasgow, United Kingdom, G12 0YN

Site 196 Neuro Centrum Odenwald

Erbach, Germany, 64711

Site 175 CHU Caremeau

Nîmes, France, 30029

Site 283 SANERA, s.r.o.

Presov, Slovakia, 8001

Site 334 Seacroft Hospital

Leeds, United Kingdom, LS14 6UH

Site 243 NZOZ Poradnia Leczenia Bólu

Gdynia, Poland, 81-049

Site 113 AKH Linz

Linz, Austria, 4020

Site 131 UZ Brussels

Brussels, Belgium, 1090

Site 204 Athens Naval Hospital

Athens, Greece, 115 21

Site 222 A.O.U Ospedali Riuniti

Foggia, Italy, 71100

Site 143 UMHAT - Stara Zagora

Stara Zagora, Bulgaria, 6000

Site 145 Military Medical Academy

Sofia, Bulgaria, 1606

Site 211 Jahn Ferenc Dél-Pesti Kórház és Rendelőintézet Fájdalom Ambulancia

Budapest, Hungary, H-1204

Site 135 ZNA Middelheim

Antwerpen, Belgium, 2020

Site 171 Hospital Ambroise Pare

Boulogne Billancourt, France, 92100

Site 226 Presidio Ospedale G.Mazzini

Teramo, Italy, 64100

Site 261 Quantum Medical Center SRL

Bucuresti, Romania, 011422

Site 183 D. Metreveli Medical Center

Tbilisi, Georgia

Site 133 Heilig Hart Ziekenhuis

Roeselare, Belgium, 8800

Site 114 Klinikum Klagenfurt Worthersee

Klagenfurt, Austria, 9020

Site 335 The Christies NHS Foundation

Manchester, United Kingdom, M20 4BX

Site 274 Saint-Petersburg State Medical University

Saint-Petersburg, Russian Federation

Site 182 S. Khechinashvili University Clinic

Tbilisi, Georgia

Site 176 CH Regional de Valence

Valence, France, 26953

Site 326 Maramara University, Pendik Training and Research Hospital

Istanbul, Turkey, 34890

Site 322 Ufuk University Dr Rıdvan Ege Training and Research Hospital

Ankara, Turkey, 06520

Site 331 The Walton Centre

Liverpool, United Kingdom, L9 7LJ

Site 146 MHAT Alexandrovska Hospital

Sofia, Bulgaria, 1431

Site 161 Finnmedi OY

Tampere, Finland, 33520

Site 281 AB-BA ambulancia

Bratislava, Slovakia, 85107

Site 141 Centre for Mental Health

Ruse, Bulgaria, 7000

Site 302 Hospital Plató

Barcelona, Spain, 08006

Site 213 Semmelweis Egyetem Molekuláris Neurológiai Klinikai és Kutatási Központ

Budapest, Hungary, H-1083

Site 271 First Moscow State Medical University named after I.M. Sechenov

Moscow, Russian Federation

Site 195 Universitätsklinikum Bonn

Bonn, Germany, 53105

Site 212 Pécsi Tudományegyetem Klinikai Központ Neurológiai Klinika

Pécs, Hungary, H-7623

Site 201 Aretaieio University Hospital

Athens, Greece, 115 28

Site 162 Vassa Central Hospital

Vaasa, Finland, 65130

Site 303 Hospital Universitario Virgen

Granada, Spain, 18014

Site 102 Medical Center Erebuni

Yerevan, Armenia

Site 311 Karolinska University Hospital

Stockholm, Sweden, 14186

Site 101 Medical Union 2

Yerevan, Armenia

Site 225 Policlinico San Donato

Milano, Italy, 20097

Site 272 City Clinical Hospital # 12

Moscow, Russian Federation

Site 245 Poradnia Leczenia Bólu, Uniwer

Gdańsk, Poland, 80-952

Site 203 Aretaieio/Maginio Hospital

Athens, Greece, 115 28

Site 229 Azienda Ospedaliero di Perugia

Perugia, Italy, 06156

Site 199 Bergmannstrost

Halle/Saale, Germany, 06112

Site 252 Instituto Portuges de Oncologic

Lisboa, Portugal, 1099-023

Site 223 AOU San Giovanni Battista

Torino, Italy, 10126

Site 142 UMHAT – Pleven

Pleven, Bulgaria, 5800

Site 323 Ege University Medical Faculty Hospital

Izmir, Turkey, 35100

Site 273 Military Medical Academy

Saint-Petersburg, Russian Federation

Site 178 Centre Alexis Vautrin

Nancy, France, 54511

Site 137 Univ. Ziekenhuis Antwerpen

Edegem, Belgium, 2650

Site 246 NZOZ Poradnia Leczenia Bolu Pr

Tychy, Poland, 43-100

Site 194 Schmerz Palliativznt Wiesbaden

Wiesbaden, Germany, 65189

Site 251 Hospital Beatriz Angelo

Loures, Portugal, 2674-514

Site 147 MHAT Sv. Ivan Rilski

Sofia, Bulgaria, 1431

Site 115 Medical University Innsbruck

Innsbruck, Austria, 6020

Site 325 Pamukkale University Medical Faculty Hospital

Denizli, Turkey, 20070

Site 174 Hopital Neurologique Pierre W

Bron, France, 69677

Site 313 SU/Östra

Göteborg, Sweden, 41685

Site 136 UZ Pellenberg

Pellenberg, Belgium, 3212

Site 192 Universitätsklinikum Giessen

Gießen, Germany, 35385

Site 121 Vitebsk Regional Clinical Hospital # 1

Vitebsk, Belarus

Site 264 Spitalul Clinic Colentina

Bucuresti, Romania, 020125

Site 151 Fakultni nemocnice Plzen

Plzen, Czech Republic, 305 99

Site 173 CHU Hopital Nord

Saint-Etienne, France, 42055

Site 132 Ziekenhuis Oost-Limburg

Genk, Belgium, 3600

Site 134 Grand Hospital de Charleroi

Charleroi, Belgium, 6000

Site 263 Spitalul Clinic Judetean de Ur

Timisoara, Romania, 300736

Site 144 Tokuda Hospital Sofia

Sofia, Bulgaria, 1407

Site 312 Karolinska University Hospital

Stockholm, Sweden, 17176

Site 244 Niepubliczny Zakład Opieki Zdr

Gdańsk, Poland, 80-286

Site 104 Medical Center "Surb Nerses Mets"

Yerevan, Armenia

Site 193 Universitätsklinikum Münster

Münster, Germany, 48149

Site 111 AKH Universitatsklinik

Vienna, Austria, 1090

Site 138 Cliniques Universitaires Saint

Bruxelles, Belgium, 1200

Site 278 Semashko Regional Clinical Hospital

Nizhniy Novgorod, Russian Federation

Site 202 Hippokration General Hospital of Athens

Athens, Greece, 115 27

Site 197 Universitätsklinikum Würzburg

Würzburg, Germany, 97080

Site 123 Grodno Regional Clinical Hospital

Grodno, Belarus

Site 301 Hospital General Universitario de Alicante

Alicante, Spain, 03010

Site 292 University Medical Centre Mari

Maribor, Slovenia, 2000

Site 122 Republican Clinical Medical Center

Minsk, Belarus

Site 324 Dokuz Eylul University Medical Faculty Hospital

Izmir, Turkey, 35340

Site 277 Hospital №40 of Kurortniy

Saint-Petersburg, Russian Federation

Site 321 Hacettepe University Medical Faculty Hospital

Ankara, Turkey, 06100

Site 228 Azienda Ospedaliero di Perugia

Perugia, Italy, 06156

Site 336 Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Site 275 Russian State Medical University named after N.I. Pirogov

Moscow, Russian Federation

Site 232 Ospedale Niguarda Ca' Granda

Milan, Italy, 20146

Site 227 Azienda Ospedaliera Universita

Firenze, Italy, 50134

Site 172 Hospital Saint Antoine

Paris, France, 75012

Site 103 Scientific research Institute of physiotherapy

Yerevan, Armenia

Site 112 Wilhelminenspital

Vienna, Austria, 1160

Site 282 Neurological surgery

Bratislava, Slovakia, 811 01

Site 221 FONDAZIONE S.MAUGERI I.R.C.C.S

Pavia, Italy, 27100

Site 333 St Thomas’ Hospital

London, United Kingdom, SE1 7EH

Site 230 Azienda Ospedaliera SantaMaria

Terni, Italy, 05100

Site 242 NZOZ Centrum Medyczne

Warszawa, Poland, 02-793

Site 200 Prax S.Wolf u.B.Schütz Pal.med

Cottbus, Germany, 03050

Site 266 Spitalul Clinic de Urgenta "Pr

Iasi, Romania, 700309

Site 291 University Clinical Center Lju

Ljubljana, Slovenia, 1525

Site 116 Krankenhaus der Barmherzigen B

Graz, Austria, 8020

Site 181 Scientific Research Institute of Clinical Medicine

Tbilisi, Georgia

Site 265 Spit Clin Judetean de Urgenta

Targu Mures, Romania, 540136

Site 254 Hospital Fernando Fonseca

Amadora, Portugal, 2700

Site 163 ORTON Invalidisaatio

Helsinki, Finland, 00280

Site 214 Josa Andras Training Hospital

Nyiregyhaza, Hungary

Site 231 Ospedale S. Chiara

Pisa, Italy, 56126

Site 153 Klinika anesteziologie

Praha, Czech Republic, 128 08

Site 241 Tomasz Dąbrowski Śląskie Centr

Katowice, Poland, 40-084

Site 177 Hospital Roger Salengro CHRU

Lille, France, 59037

Site 276 OOO Clinical Neurology Center

Novosibirsk, Russian Federation

Site 262 Spitalul Clinic Judetean de Ur

Constanta, Romania, 900591

Site 152 Univ. Hospital U. Sv. Anny

Brno, Czech Republic, 656 91

Site 305 Hospital Universitario Politécnico La Fe

Valencia, Spain, 46026

Site 253 CHS - Hosp. S. Bernardo

Setúbal, Portugal, 2910-446