Clinical trial NCT01713426: A Study to Compare QUTENZA With Pregabalin for the Treatment of Peripheral Neuropathic Pain (PNP) After 8 Weeks of Treatment
Official title: Qutenza Versus Pregabalin in Subjects With Peripheral Neuropathic Pain: an Open-label, Randomized, Multicenter, Non-inferiority Efficacy and Tolerability Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-diabetic Painful Peripheral Polyneuropathy
Postherpetic Neuralgia (PHN)
Peripheral Nerve Injury (PNI)
Keywords: Post herpetic neuralgia
Qutenza
NGX-4010
Peripheral Neuropathic Pain
Pregabalin
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-10-24
Enrollment: 568
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Baseline and week 8
Secondary outcomes:
measure: Proportion of subjects in each arm who achieve "optimal Therapeutic effect"
timeFrame: Baseline and week 8
measure: Proportion of subjects who achieve at least a 30% decrease in the "average pain for the past 24 hours"
timeFrame: Baseline to Week 8
measure: Proportion of subjects who achieve at least a 50% decrease in the "average pain for the past 24 hours"
timeFrame: Baseline to Week 8
measure: Absolute and percent change in "average pain for the past 24 hours"
timeFrame: Baseline to Week 8
measure: Time to onset of pain relief (in days)
timeFrame: Up to 8 weeks
measure: Overall subject status using Patient Global Impression of Change (PGIC) questionnaire
timeFrame: At Weeks 4 and 8
measure: Change in the Medical Outcomes Study (MOS) 6-Item Cognitive Functioning Scale
timeFrame: Baseline to Week 8
measure: MOS - Sleep Scale
timeFrame: Baseline to Weeks 4 and 8
measure: Change in the EQ-5D-5L (Euroqol-5 dimensions-5 levels) total score
timeFrame: Baseline to Week 8
measure: Treatment satisfaction
timeFrame: Baseline to Weeks 4 and 8
measure: Treatment satisfaction - continuance of treatment
timeFrame: Week 8
measure: Time to reach optimal maintenance dose for pregabalin
timeFrame: Baseline to Week 8
measure: Healthcare Resource use
timeFrame: Baseline to Week 8
measure: Tolerability (Assessed by the number, severity and duration of ADRs)
timeFrame: Baseline to Week 8
measure: Change in intensity and area of allodynia
timeFrame: Baseline to Week 8
measure: Changes in sensory symptoms
timeFrame: Baseline to Week 8
measure: Reduction in pain
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: Site 101 Medical Union 2
city: Yerevan
country: Armenia
facility: Site 102 Medical Center Erebuni
city: Yerevan
country: Armenia
facility: Site 103 Scientific research Institute of physiotherapy
city: Yerevan
country: Armenia
facility: Site 104 Medical Center "Surb Nerses Mets"
city: Klagenfurt
country: Austria
facility: Site 114 Klinikum Klagenfurt Worthersee
state: Carynthia
city: Innsbruck
country: Austria
facility: Site 115 Medical University Innsbruck
state: Tyrol
city: Graz
country: Austria
facility: Site 116 Krankenhaus der Barmherzigen B
city: Vienna
country: Austria
facility: Site 111 AKH Universitatsklinik
city: Vienna
country: Austria
facility: Site 112 Wilhelminenspital
city: Vitebsk
country: Belarus
facility: Site 121 Vitebsk Regional Clinical Hospital # 1
city: Brussels
country: Belgium
facility: Site 131 UZ Brussels
city: Bruxelles
country: Belgium
facility: Site 138 Cliniques Universitaires Saint
city: Charleroi
country: Belgium
facility: Site 134 Grand Hospital de Charleroi
city: Edegem
country: Belgium
facility: Site 137 Univ. Ziekenhuis Antwerpen
city: Genk
country: Belgium
facility: Site 132 Ziekenhuis Oost-Limburg
city: Pellenberg
country: Belgium
facility: Site 136 UZ Pellenberg
city: Roeselare
country: Belgium
facility: Site 133 Heilig Hart Ziekenhuis
city: Pleven
country: Bulgaria
facility: Site 142 UMHAT - Pleven
city: Ruse
country: Bulgaria
facility: Site 141 Centre for Mental Health
city: Sofia
country: Bulgaria
facility: Site 144 Tokuda Hospital Sofia
city: Sofia
country: Bulgaria
facility: Site 146 MHAT Alexandrovska Hospital
city: Sofia
country: Bulgaria
facility: Site 147 MHAT Sv. Ivan Rilski
city: Sofia
country: Bulgaria
facility: Site 145 Military Medical Academy
city: Plzen
country: Czechia
facility: Site 151 Fakultni nemocnice Plzen
city: Praha
country: Czechia
facility: Site 153 Klinika anesteziologie
city: Helsinki
country: Finland
facility: Site 163 ORTON Invalidisaatio
city: Tampere
country: Finland
facility: Site 161 Finnmedi OY
city: Vaasa
country: Finland
facility: Site 162 Vassa Central Hospital
city: Boulogne Billancourt
country: France
facility: Site 171 Hospital Ambroise Pare
city: Bron
country: France
facility: Site 174 Hopital Neurologique Pierre W
city: Lille
country: France
facility: Site 177 Hospital Roger Salengro CHRU
city: Nîmes
country: France
facility: Site 175 CHU Caremeau
city: Paris
country: France
facility: Site 172 Hospital Saint Antoine
city: Saint-Etienne
country: France
facility: Site 173 CHU Hopital Nord
city: Valence
country: France
facility: Site 176 CH Regional de Valence
city: Cottbus
country: Germany
facility: Site 200 Prax S.Wolf u.B.Schütz Pal.med
city: Gießen
country: Germany
facility: Site 192 Universitätsklinikum Giessen
city: Münster
country: Germany
facility: Site 193 Universitätsklinikum Münster
city: Wiesbaden
country: Germany
facility: Site 194 Schmerz Palliativznt Wiesbaden
city: Würzburg
country: Germany
facility: Site 197 Universitätsklinikum Würzburg
city: Athens
country: Greece
facility: Site 204 Athens Naval Hospital
city: Athens
country: Greece
facility: Site 202 Hippokration General Hospital of Athens
city: Athens
country: Greece
facility: Site 201 Aretaieio University Hospital
city: Athens
country: Greece
facility: Site 203 Aretaieio/Maginio Hospital
city: Budapest
country: Hungary
facility: Site 213 Semmelweis Egyetem Molekuláris Neurológiai Klinikai és Kutatási Központ
city: Firenze
country: Italy
facility: Site 227 Azienda Ospedaliera Universita
city: Foggia
country: Italy
facility: Site 222 A.O.U Ospedali Riuniti
city: Milano
country: Italy
facility: Site 225 Policlinico San Donato
city: Milan
country: Italy
facility: Site 232 Ospedale Niguarda Ca' Granda
city: Pavia
country: Italy
facility: Site 221 FONDAZIONE S.MAUGERI I.R.C.C.S
city: Perugia
country: Italy
facility: Site 228 Azienda Ospedaliero di Perugia
city: Perugia
country: Italy
facility: Site 229 Azienda Ospedaliero di Perugia
city: Pisa
country: Italy
facility: Site 231 Ospedale S. Chiara
city: Teramo
country: Italy
facility: Site 226 Presidio Ospedale G.Mazzini
city: Terni
country: Italy
facility: Site 230 Azienda Ospedaliera SantaMaria
city: Torino
country: Italy
facility: Site 223 AOU San Giovanni Battista
city: Gdańsk
country: Poland
facility: Site 244 Niepubliczny Zakład Opieki Zdr
city: Gdańsk
country: Poland
facility: Site 245 Poradnia Leczenia Bólu, Uniwer
city: Gdynia
country: Poland
facility: Site 243 NZOZ Poradnia Leczenia Bólu
city: Katowice
country: Poland
facility: Site 241 Tomasz Dąbrowski Śląskie Centr
city: Tychy
country: Poland
facility: Site 246 NZOZ Poradnia Leczenia Bolu Pr
city: Warszawa
country: Poland
facility: Site 242 NZOZ Centrum Medyczne
city: Amadora
country: Portugal
facility: Site 254 Hospital Fernando Fonseca
city: Lisboa
country: Portugal
facility: Site 252 Instituto Portuges de Oncologic
city: Setúbal
country: Portugal
facility: Site 253 CHS - Hosp. S. Bernardo
city: Bucuresti
country: Romania
facility: Site 261 Quantum Medical Center SRL
city: Bucuresti
country: Romania
facility: Site 264 Spitalul Clinic Colentina
city: Constanta
country: Romania
facility: Site 262 Spitalul Clinic Judetean de Ur
city: Iasi
country: Romania
facility: Site 266 Spitalul Clinic de Urgenta "Pr
city: Targu Mures
country: Romania
facility: Site 265 Spit Clin Judetean de Urgenta
city: Timisoara
country: Romania
facility: Site 263 Spitalul Clinic Judetean de Ur
city: Moscow
country: Russian Federation
facility: Site 271 First Moscow State Medical University named after I.M. Sechenov
city: Moscow
country: Russian Federation
facility: Site 272 City Clinical Hospital # 12
city: Nizhniy Novgorod
country: Russian Federation
facility: Site 278 Semashko Regional Clinical Hospital
city: Novosibirsk
country: Russian Federation
facility: Site 276 OOO Clinical Neurology Center
city: Saint-Petersburg
country: Russian Federation
facility: Site 273 Military Medical Academy
city: Saint-Petersburg
country: Russian Federation
facility: Site 274 Saint-Petersburg State Medical University
city: Saint-Petersburg
country: Russian Federation
facility: Site 277 Hospital №40 of Kurortniy
city: Bratislava
country: Slovakia
facility: Site 282 Neurological surgery
city: Bratislava
country: Slovakia
facility: Site 281 AB-BA ambulancia
city: Presov
country: Slovakia
facility: Site 283 SANERA, s.r.o.
city: Maribor
country: Slovenia
facility: Site 292 University Medical Centre Mari
city: Alicante
country: Spain
facility: Site 301 Hospital General Universitario de Alicante
city: Granada
country: Spain
facility: Site 303 Hospital Universitario Virgen
city: Göteborg
country: Sweden
facility: Site 313 SU/Östra
city: Stockholm
country: Sweden
facility: Site 311 Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Site 312 Karolinska University Hospital
city: Ankara
country: Turkey
facility: Site 321 Hacettepe University Medical Faculty Hospital
city: Denizli
country: Turkey
facility: Site 325 Pamukkale University Medical Faculty Hospital
city: Istanbul
country: Turkey
facility: Site 326 Maramara University, Pendik Training and Research Hospital
city: Izmir
country: Turkey
facility: Site 323 Ege University Medical Faculty Hospital
city: Izmir
country: Turkey
facility: Site 324 Dokuz Eylul University Medical Faculty Hospital
city: Glasgow
country: United Kingdom
facility: Site 332 Gartnavel General Hospital
city: Leeds
country: United Kingdom
facility: Site 334 Seacroft Hospital
city: Leicester
country: United Kingdom
facility: Site 336 Leicester Royal Infirmary
city: Liverpool
country: United Kingdom
facility: Site 331 The Walton Centre
city: London
country: United Kingdom
facility: Site 333 St Thomas' Hospital
city: Manchester
country: United Kingdom
facility: Site 335 The Christies NHS Foundation
Study officials:
affiliation: Astellas Pharma Europe Ltd.
name: Clinical Study Manager
role: STUDY_CHAIR
References:
citation: 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.