A Study to Compare QUTENZA With Pregabalin for the Treatment of Peripheral Neuropathic Pain (PNP) After 8 Weeks of Treatment
NCT ID: NCT01713426
Last Updated: 2018-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
568 participants
INTERVENTIONAL
2012-07-11
2013-09-26
Brief Summary
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This study will include subjects suffering from Postherpetic Neuralgia, Peripheral Nerve Injury or Non Diabetic peripheral polyneuropathy.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Qutenza
Cutaneous patch
Qutenza
Cutaneous patch
Pregabalin
Oral capsule
Pregabalin
Oral capsule
Interventions
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Qutenza
Cutaneous patch
Pregabalin
Oral capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 2\. Localized and well-defined area of PNP, suitable for treatment with QUTENZA
* 3\. Documented diagnosis at the Baseline Visit of either:
* Postherpetic neuralgia (PHN) with pain persisting at least 6 months since shingles vesicle crusting
* Peripheral nerve injury (PNI) including post-surgical or post-traumatic neuropathic pain, persisting for a minimum of 3 months
* Non-diabetic painful peripheral polyneuropathy with pain which has persisted for a minimum of 3 months, including (i) small-fiber neuropathy, as confirmed by quantitative sensory testing (QST), laser evoked potentials (LEP) or skin biopsy, (ii) chemotherapy induced neuropathy in subjects with stable neoplastic disease, (iii) other, adequately characterized painful peripheral polyneuropathy, based on clinical history and examination
* 4\. Average pain score ≥4 during Screening Period, over a minimum of at least 4 consecutive days (using the "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score
* 5\. Intact, non-irritated, dry skin over the painful area(s) to be treated
* 6\. Is either:
* Naïve to treatment with pregabalin and gabapentin, OR
* In the opinion of the investigator, has not received an adequate trial of treatment with pregabalin or gabapentin
* 7\. Subject is willing to receive pregabalin or QUTENZA as part of the trial
* 8\. Females of child bearing potential must be willing to use highly effective methods of birth control during the study and for 30 days following study termination
Exclusion Criteria
* 2\. Complex Regional Pain Syndrome (CRPS, Type I or II)
* 3\. Neuropathic pain related to previously administered radiotherapy, diabetes mellitus or HIV-AN
* 4\. Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes
* 5\. Severe loss of heat sensation in the painful area, indicative of C-fiber denervation
* 6\. Reported daily pain score of 10 on the NPRS for at least 4 days during the Screening Period
* 7\. Past or current history of diabetes mellitus
* 8\. Unstable or poorly controlled hypertension or a recent history of a cardiovascular event which, in the opinion of the investigator, would put the subject at risk of adverse cardiovascular reactions related to the patch application procedure
* 9\. Creatinine clearance (CLcr) \< 60mL/min according to the Cockcroft-Gault formula
* 10\. Untreated ongoing generalized anxiety disorder according to DSM-IV or ICD-10 criteria
* 11\. Severe ongoing depression according to DSM-IV or ICD-10 criteria
* 12\. Evidence of cognitive impairment including dementia that may interfere with subject's ability to complete study evaluations and recall pain levels in the past 24 hours
* 13\. Planned elective surgery during the trial
* 14\. Changes to stable neuropathic pain background medication in the 4 weeks prior to the Baseline Visit
* 15\. Any prior receipt of QUTENZA patches, including blinded patches administered as part of a clinical trial
* 16\. Hypersensitivity to capsaicin (i.e., chilli peppers or Over-the-counter \[OTC\] capsaicin products), any QUTENZA excipients, local anesthetics, or adhesives
* 17\. Treatment with pregabalin or gabapentin within 2 months prior to the Baseline Visit
* 18\. Hypersensitivity to pregabalin or any of the excipients
* 19\. Use of opioids exceeding a total daily dose of morphine of 200 mg/day, or equivalent; or any intravenous opioids or tapentadol, regardless of dose, within 7 days preceding the Baseline Visit
* 20\. Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including patch containing lidocaine), steroids or capsaicin products on the painful areas to be treated within 7 days preceding the Baseline Visit
* 21\. Chemotherapy within 3 months of the Baseline Visit, except maintenance hormone treatment
* 22\. Use of any investigational agent within 30 days prior to Baseline Visit
* 23\. Active substance abuse or history of chronic substance abuse within 1 year prior to screening; or any prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator
* 24\. Female subjects of child-bearing potential with a positive serum or urine pregnancy test prior to treatment
18 Years
80 Years
ALL
No
Sponsors
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Astellas Pharma Europe Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Study Manager
Role: STUDY_CHAIR
Astellas Pharma Europe Ltd.
Locations
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Site 101 Medical Union 2
Yerevan, , Armenia
Site 102 Medical Center Erebuni
Yerevan, , Armenia
Site 103 Scientific research Institute of physiotherapy
Yerevan, , Armenia
Site 104 Medical Center "Surb Nerses Mets"
Yerevan, , Armenia
Site 114 Klinikum Klagenfurt Worthersee
Klagenfurt, Carynthia, Austria
Site 115 Medical University Innsbruck
Innsbruck, Tyrol, Austria
Site 116 Krankenhaus der Barmherzigen B
Graz, , Austria
Site 111 AKH Universitatsklinik
Vienna, , Austria
Site 112 Wilhelminenspital
Vienna, , Austria
Site 121 Vitebsk Regional Clinical Hospital # 1
Vitebsk, , Belarus
Site 131 UZ Brussels
Brussels, , Belgium
Site 138 Cliniques Universitaires Saint
Brussels, , Belgium
Site 134 Grand Hospital de Charleroi
Charleroi, , Belgium
Site 137 Univ. Ziekenhuis Antwerpen
Edegem, , Belgium
Site 132 Ziekenhuis Oost-Limburg
Genk, , Belgium
Site 136 UZ Pellenberg
Pellenberg, , Belgium
Site 133 Heilig Hart Ziekenhuis
Roeselare, , Belgium
Site 142 UMHAT - Pleven
Pleven, , Bulgaria
Site 141 Centre for Mental Health
Rousse, , Bulgaria
Site 144 Tokuda Hospital Sofia
Sofia, , Bulgaria
Site 146 MHAT Alexandrovska Hospital
Sofia, , Bulgaria
Site 147 MHAT Sv. Ivan Rilski
Sofia, , Bulgaria
Site 145 Military Medical Academy
Sofia, , Bulgaria
Site 151 Fakultni nemocnice Plzen
Pilsen, , Czechia
Site 153 Klinika anesteziologie
Prague, , Czechia
Site 163 ORTON Invalidisaatio
Helsinki, , Finland
Site 161 Finnmedi OY
Tampere, , Finland
Site 162 Vassa Central Hospital
Vaasa, , Finland
Site 171 Hospital Ambroise Pare
Boulogne-Billancourt, , France
Site 174 Hopital Neurologique Pierre W
Bron, , France
Site 177 Hospital Roger Salengro CHRU
Lille, , France
Site 175 CHU Caremeau
Nîmes, , France
Site 172 Hospital Saint Antoine
Paris, , France
Site 173 CHU Hopital Nord
Saint-Etienne, , France
Site 176 CH Regional de Valence
Valence, , France
Site 200 Prax S.Wolf u.B.Schütz Pal.med
Cottbus, , Germany
Site 192 Universitätsklinikum Giessen
Giessen, , Germany
Site 193 Universitätsklinikum Münster
Münster, , Germany
Site 194 Schmerz Palliativznt Wiesbaden
Wiesbaden, , Germany
Site 197 Universitätsklinikum Würzburg
Würzburg, , Germany
Site 204 Athens Naval Hospital
Athens, , Greece
Site 202 Hippokration General Hospital of Athens
Athens, , Greece
Site 201 Aretaieio University Hospital
Athens, , Greece
Site 203 Aretaieio/Maginio Hospital
Athens, , Greece
Site 213 Semmelweis Egyetem Molekuláris Neurológiai Klinikai és Kutatási Központ
Budapest, , Hungary
Site 227 Azienda Ospedaliera Universita
Florence, , Italy
Site 222 A.O.U Ospedali Riuniti
Foggia, , Italy
Site 232 Ospedale Niguarda Ca' Granda
Milan, , Italy
Site 225 Policlinico San Donato
Milan, , Italy
Site 221 FONDAZIONE S.MAUGERI I.R.C.C.S
Pavia, , Italy
Site 228 Azienda Ospedaliero di Perugia
Perugia, , Italy
Site 229 Azienda Ospedaliero di Perugia
Perugia, , Italy
Site 231 Ospedale S. Chiara
Pisa, , Italy
Site 226 Presidio Ospedale G.Mazzini
Teramo, , Italy
Site 230 Azienda Ospedaliera SantaMaria
Terni, , Italy
Site 223 AOU San Giovanni Battista
Torino, , Italy
Site 244 Niepubliczny Zakład Opieki Zdr
Gdansk, , Poland
Site 245 Poradnia Leczenia Bólu, Uniwer
Gdansk, , Poland
Site 243 NZOZ Poradnia Leczenia Bólu
Gdynia, , Poland
Site 241 Tomasz Dąbrowski Śląskie Centr
Katowice, , Poland
Site 246 NZOZ Poradnia Leczenia Bolu Pr
Tychy, , Poland
Site 242 NZOZ Centrum Medyczne
Warsaw, , Poland
Site 254 Hospital Fernando Fonseca
Amadora, , Portugal
Site 252 Instituto Portuges de Oncologic
Lisbon, , Portugal
Site 253 CHS - Hosp. S. Bernardo
Setúbal, , Portugal
Site 261 Quantum Medical Center SRL
Bucharest, , Romania
Site 264 Spitalul Clinic Colentina
Bucharest, , Romania
Site 262 Spitalul Clinic Judetean de Ur
Constanța, , Romania
Site 266 Spitalul Clinic de Urgenta "Pr
Iași, , Romania
Site 265 Spit Clin Judetean de Urgenta
Târgu Mureş, , Romania
Site 263 Spitalul Clinic Judetean de Ur
Timișoara, , Romania
Site 271 First Moscow State Medical University named after I.M. Sechenov
Moscow, , Russia
Site 272 City Clinical Hospital # 12
Moscow, , Russia
Site 278 Semashko Regional Clinical Hospital
Nizhny Novgorod, , Russia
Site 276 OOO Clinical Neurology Center
Novosibirsk, , Russia
Site 273 Military Medical Academy
Saint Petersburg, , Russia
Site 274 Saint-Petersburg State Medical University
Saint Petersburg, , Russia
Site 277 Hospital №40 of Kurortniy
Saint Petersburg, , Russia
Site 282 Neurological surgery
Bratislava, , Slovakia
Site 281 AB-BA ambulancia
Bratislava, , Slovakia
Site 283 SANERA, s.r.o.
Prešov, , Slovakia
Site 292 University Medical Centre Mari
Maribor, , Slovenia
Site 301 Hospital General Universitario de Alicante
Alicante, , Spain
Site 303 Hospital Universitario Virgen
Granada, , Spain
Site 313 SU/Östra
Gothenburg, , Sweden
Site 311 Karolinska University Hospital
Stockholm, , Sweden
Site 312 Karolinska University Hospital
Stockholm, , Sweden
Site 321 Hacettepe University Medical Faculty Hospital
Ankara, , Turkey (Türkiye)
Site 325 Pamukkale University Medical Faculty Hospital
Denizli, , Turkey (Türkiye)
Site 326 Maramara University, Pendik Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Site 323 Ege University Medical Faculty Hospital
Izmir, , Turkey (Türkiye)
Site 324 Dokuz Eylul University Medical Faculty Hospital
Izmir, , Turkey (Türkiye)
Site 332 Gartnavel General Hospital
Glasgow, , United Kingdom
Site 334 Seacroft Hospital
Leeds, , United Kingdom
Site 336 Leicester Royal Infirmary
Leicester, , United Kingdom
Site 331 The Walton Centre
Liverpool, , United Kingdom
Site 333 St Thomas' Hospital
London, , United Kingdom
Site 335 The Christies NHS Foundation
Manchester, , United Kingdom
Countries
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References
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Viel E, Eerdekens M, Kandaswamy P. Treatment Impact on Patient-Reported Outcomes in Peripheral Neuropathic Pain: Comparing Single Intervention With Topical High-Concentration Capsaicin to Daily Oral Pregabalin. Pain Physician. 2021 Sep;24(6):453-463.
Related Links
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Link to results on EudraCT
Link to results on Astellas Clinical Study Results website
Other Identifiers
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2011-005872-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
QTZ-EC-0004
Identifier Type: -
Identifier Source: org_study_id
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