A Study to Compare QUTENZA With Pregabalin for the Treatment of Peripheral Neuropathic Pain (PNP) After 8 Weeks of Treatment

Condition(s) targeted: Postherpetic Neuralgia (PHN); Peripheral Nerve Injury (PNI); Non-diabetic Painful Peripheral Polyneuropathy

Intervention: Qutenza (Drug); Pregabalin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Astellas Pharma Europe Ltd.

Official(s) and/or principal investigator(s):
Clinical Study Manager, Study Chair, Affiliation: Astellas Pharma Europe Ltd.

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.

Official title: Qutenza Versus Pregabalin in Subjects With Peripheral Neuropathic Pain: an Open-label, Randomized, Multicenter, Non-inferiority Efficacy and Tolerability Study

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportion of subjects in each arm who achieve at least 30% decrease in the "average pain for the past 24 hours" Numeric Pain Rating Scale (NPRS) score from baseline to week 8

Secondary outcome:

Proportion of subjects in each arm who achieve "optimal Therapeutic effect"

Proportion of subjects who achieve at least a 30% decrease in the "average pain for the past 24 hours"

Proportion of subjects who achieve at least a 50% decrease in the "average pain for the past 24 hours"

Absolute and percent change in "average pain for the past 24 hours"

Time to onset of pain relief (in days)

Overall subject status using Patient Global Impression of Change (PGIC) questionnaire

Change in the Medical Outcomes Study (MOS) 6-Item Cognitive Functioning Scale

MOS - Sleep Scale

Change in the EQ-5D-5L (Euroqol-5 dimensions-5 levels) total score

Treatment satisfaction

Treatment satisfaction - continuance of treatment

Time to reach optimal maintenance dose for pregabalin

Healthcare Resource use

Tolerability (Assessed by the number, severity and duration of ADRs)

Change in intensity and area of allodynia

Changes in sensory symptoms

Reduction in pain

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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

Link to Results on JAPIC - enter 140559 in the JapicCTI-RNo. field

Link to results on EudraCT

Starting date: July 2012
Last updated: June 12, 2015