This study is comparing the efficacy and tolerability of Qutenza with that of pregabalin in
patients suffering from peripheral neuropathic pain. Treatment allocation will be to one of
these treatments and the duration of the study will be about 10 weeks (assuming that from
screening to treatment allocation takes 2 weeks). Participants will be asked to complete
questionnaires about various aspects relating to their condition throughout the study.
This study will include subjects suffering from Postherpetic Neuralgia, Peripheral Nerve
Injury or Non Diabetic peripheral polyneuropathy.
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Inclusion Criteria:
- 1. Documented diagnosis of probable or definite PNP
- 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:
- 1. Significant ongoing or recurrent pain of etiology other than PHN, PNI or
non-diabetic painful peripheral polyneuropathy, for example: compression-related
neuropathies (e. g. spinal stenosis), radiculopathy, tumor-related pain, fibromyalgia
or arthritis
- 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
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 116 Krankenhaus der Barmherzigen B, Graz 8020, Austria
Site 111 AKH Universitatsklinik, Vienna 1090, Austria
Site 112 Wilhelminenspital, Vienna 1160, Austria
Site 121 Vitebsk Regional Clinical Hospital # 1, Vitebsk, Belarus
Site 131 UZ Brussels, Brussels 1090, Belgium
Site 138 Cliniques Universitaires Saint, Bruxelles 1200, Belgium
Site 134 Grand Hospital de Charleroi, Charleroi 6000, Belgium
Site 137 Univ. Ziekenhuis Antwerpen, Edegem 2650, Belgium
Site 132 Ziekenhuis Oost-Limburg, Genk 3600, Belgium
Site 136 UZ Pellenberg, Pellenberg 3212, Belgium
Site 133 Heilig Hart Ziekenhuis, Roeselare 8800, Belgium
Site 142 UMHAT - Pleven, Pleven 5800, Bulgaria
Site 141 Centre for Mental Health, Ruse 7000, Bulgaria
Site 144 Tokuda Hospital Sofia, Sofia 1407, Bulgaria
Site 145 Military Medical Academy, Sofia 1606, Bulgaria
Site 146 MHAT Alexandrovska Hospital, Sofia 1431, Bulgaria
Site 147 MHAT Sv. Ivan Rilski, Sofia 1431, Bulgaria
Site 151 Fakultni nemocnice Plzen, Plzen 305 99, Czech Republic
Site 153 Klinika anesteziologie, Praha 128 08, Czech Republic
Site 163 ORTON Invalidisaatio, Helsinki 00280, Finland
Site 161 Finnmedi OY, Tampere 33520, Finland
Site 162 Vassa Central Hospital, Vaasa 65130, Finland
Site 171 Hospital Ambroise Pare, Boulogne Billancourt 92100, France
Site 174 Hopital Neurologique Pierre W, Bron 69677, France
Site 177 Hospital Roger Salengro CHRU, Lille 59037, France
Site 175 CHU Caremeau, Nîmes 30029, France
Site 172 Hospital Saint Antoine, Paris 75012, France
Site 173 CHU Hopital Nord, Saint-Etienne 42055, France
Site 176 CH Regional de Valence, Valence 26953, France
Site 200 Prax S.Wolf u.B.Schütz Pal.med, Cottbus 03050, Germany
Site 192 Universitätsklinikum Giessen, Gießen 35385, Germany
Site 193 Universitätsklinikum Münster, Münster 48149, Germany
Site 194 Schmerz Palliativznt Wiesbaden, Wiesbaden 65189, Germany
Site 197 Universitätsklinikum Würzburg, Würzburg 97080, Germany
Site 201 Aretaieio University Hospital, Athens 115 28, Greece
Site 202 Hippokration General Hospital of Athens, Athens 115 27, Greece
Site 203 Aretaieio/Maginio Hospital, Athens 115 28, Greece
Site 204 Athens Naval Hospital, Athens 115 21, Greece
Site 213 Semmelweis Egyetem Molekuláris Neurológiai Klinikai és Kutatási Központ, Budapest H-1083, Hungary
Site 227 Azienda Ospedaliera Universita, Firenze 50134, Italy
Site 222 A.O.U Ospedali Riuniti, Foggia 71100, Italy
Site 225 Policlinico San Donato, Milano 20097, Italy
Site 232 Ospedale Niguarda Ca' Granda, Milan 20146, Italy
Site 221 FONDAZIONE S.MAUGERI I.R.C.C.S, Pavia 27100, Italy
Site 228 Azienda Ospedaliero di Perugia, Perugia 06156, Italy
Site 229 Azienda Ospedaliero di Perugia, Perugia 06156, Italy
Site 231 Ospedale S. Chiara, Pisa 56126, Italy
Site 226 Presidio Ospedale G.Mazzini, Teramo 64100, Italy
Site 230 Azienda Ospedaliera SantaMaria, Terni 05100, Italy
Site 223 AOU San Giovanni Battista, Torino 10126, Italy
Site 244 Niepubliczny Zakład Opieki Zdr, Gdańsk 80-286, Poland
Site 245 Poradnia Leczenia Bólu, Uniwer, Gdańsk 80-952, Poland
Site 243 NZOZ Poradnia Leczenia Bólu, Gdynia 81-049, Poland
Site 241 Tomasz Dąbrowski Śląskie Centr, Katowice 40-084, Poland
Site 246 NZOZ Poradnia Leczenia Bolu Pr, Tychy 43-100, Poland
Site 242 NZOZ Centrum Medyczne, Warszawa 02-793, Poland
Site 254 Hospital Fernando Fonseca, Amadora 2700, Portugal
Site 252 Instituto Portuges de Oncologic, Lisboa 1099-023, Portugal
Site 253 CHS - Hosp. S. Bernardo, Setúbal 2910-446, Portugal
Site 261 Quantum Medical Center SRL, Bucuresti 011422, Romania
Site 264 Spitalul Clinic Colentina, Bucuresti 020125, Romania
Site 262 Spitalul Clinic Judetean de Ur, Constanta 900591, Romania
Site 266 Spitalul Clinic de Urgenta "Pr, Iasi 700309, Romania
Site 265 Spit Clin Judetean de Urgenta, Targu Mures 540136, Romania
Site 263 Spitalul Clinic Judetean de Ur, Timisoara 300736, Romania
Site 271 First Moscow State Medical University named after I.M. Sechenov, Moscow, Russian Federation
Site 272 City Clinical Hospital # 12, Moscow, Russian Federation
Site 278 Semashko Regional Clinical Hospital, Nizhniy Novgorod, Russian Federation
Site 276 OOO Clinical Neurology Center, Novosibirsk, Russian Federation
Site 273 Military Medical Academy, Saint-Petersburg, Russian Federation
Site 274 Saint-Petersburg State Medical University, Saint-Petersburg, Russian Federation
Site 277 Hospital №40 of Kurortniy, Saint-Petersburg, Russian Federation
Site 281 AB-BA ambulancia, Bratislava 85107, Slovakia
Site 282 Neurological surgery, Bratislava 811 01, Slovakia
Site 283 SANERA, s.r.o., Presov 8001, Slovakia
Site 292 University Medical Centre Mari, Maribor 2000, Slovenia
Site 301 Hospital General Universitario de Alicante, Alicante 03010, Spain
Site 303 Hospital Universitario Virgen, Granada 18014, Spain
Site 313 SU/Östra, Göteborg 41685, Sweden
Site 311 Karolinska University Hospital, Stockholm 14186, Sweden
Site 312 Karolinska University Hospital, Stockholm 17176, Sweden
Site 321 Hacettepe University Medical Faculty Hospital, Ankara 06100, Turkey
Site 325 Pamukkale University Medical Faculty Hospital, Denizli 20070, Turkey
Site 326 Maramara University, Pendik Training and Research Hospital, Istanbul 34890, Turkey
Site 323 Ege University Medical Faculty Hospital, Izmir 35100, Turkey
Site 324 Dokuz Eylul University Medical Faculty Hospital, Izmir 35340, Turkey
Site 332 Gartnavel General Hospital, Glasgow G12 0YN, United Kingdom
Site 334 Seacroft Hospital, Leeds LS14 6UH, United Kingdom
Site 336 Leicester Royal Infirmary, Leicester LE1 5WW, United Kingdom
Site 331 The Walton Centre, Liverpool L9 7LJ, United Kingdom
Site 333 St Thomas' Hospital, London SE1 7EH, United Kingdom
Site 335 The Christies NHS Foundation, Manchester M20 4BX, United Kingdom
Site 114 Klinikum Klagenfurt Worthersee, Klagenfurt, Carynthia 9020, Austria
Site 115 Medical University Innsbruck, Innsbruck, Tyrol 6020, Austria