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

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ClinicalTrials.gov Identifier: NCT01713426
Recruitment Status : Completed
First Posted : October 24, 2012
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )

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.


Condition or disease Intervention/treatment Phase
Non-diabetic Painful Peripheral Polyneuropathy Postherpetic Neuralgia (PHN) Peripheral Nerve Injury (PNI) Drug: Qutenza Drug: Pregabalin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 568 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Qutenza Versus Pregabalin in Subjects With Peripheral Neuropathic Pain: an Open-label, Randomized, Multicenter, Non-inferiority Efficacy and Tolerability Study
Actual Study Start Date : July 11, 2012
Actual Primary Completion Date : September 26, 2013
Actual Study Completion Date : September 26, 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Qutenza
Cutaneous patch
Drug: Qutenza
Cutaneous patch
Other Name: Capsaicin

Active Comparator: Pregabalin
Oral capsule
Drug: Pregabalin
Oral capsule




Primary Outcome Measures :
  1. 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 [ Time Frame: Baseline and week 8 ]

Secondary Outcome Measures :
  1. Proportion of subjects in each arm who achieve "optimal Therapeutic effect" [ Time Frame: Baseline and week 8 ]

    Optimal therapeutic effect is defined as:

    • No change in background chronic pain medication and no discontinuation of study drug due to lack of efficacy or tolerability prior to Week 8
    • At least a 30% reduction in the "average pain for the past 24 hours" NPRS score, from baseline to Week 8, and
    • No moderate or severe adverse drug reactions (ADRs) during the stable Treatment Period

  2. Proportion of subjects who achieve at least a 30% decrease in the "average pain for the past 24 hours" [ Time Frame: Baseline to Week 8 ]
    NPRS score from baseline to the mean of all scores recorded between Week 1 (Day 8) and Week 8 (Day 57)

  3. Proportion of subjects who achieve at least a 50% decrease in the "average pain for the past 24 hours" [ Time Frame: Baseline to Week 8 ]
    NPRS score from baseline to week 8, and from baseline to the mean of all scores recorded between Week 1 (Day 8) and Week 8 (Day 57)

  4. Absolute and percent change in "average pain for the past 24 hours" [ Time Frame: Baseline to Week 8 ]
    NPRS score from baseline to Week 8, and from baseline to the mean of all scores recorded between Weeks 1 to 8

  5. Time to onset of pain relief (in days) [ Time Frame: Up to 8 weeks ]
    Assessed by at least a 30% reduction in "average pain for the past 24 hours" NPRS score

  6. Overall subject status using Patient Global Impression of Change (PGIC) questionnaire [ Time Frame: At Weeks 4 and 8 ]
  7. Change in the Medical Outcomes Study (MOS) 6-Item Cognitive Functioning Scale [ Time Frame: Baseline to Week 8 ]
  8. MOS - Sleep Scale [ Time Frame: Baseline to Weeks 4 and 8 ]
  9. Change in the EQ-5D-5L (Euroqol-5 dimensions-5 levels) total score [ Time Frame: Baseline to Week 8 ]
  10. Treatment satisfaction [ Time Frame: Baseline to Weeks 4 and 8 ]

    As assessed by:

    • Proportion of subjects who discontinue study drug or withdraw from the study due to either a lack of efficacy or tolerability
    • Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire at Week 4 and Week 8

  11. Treatment satisfaction - continuance of treatment [ Time Frame: Week 8 ]
    As assessed by willingness to continue treatment at Week 8

  12. Time to reach optimal maintenance dose for pregabalin [ Time Frame: Baseline to Week 8 ]
  13. Healthcare Resource use [ Time Frame: Baseline to Week 8 ]
    Number of contacts with health professionals

  14. Tolerability (Assessed by the number, severity and duration of ADRs) [ Time Frame: Baseline to Week 8 ]
    Collected as self-rated health-related complaints by the subject and then medically confirmed and causality assigned by the investigator

  15. Change in intensity and area of allodynia [ Time Frame: Baseline to Week 8 ]
  16. Changes in sensory symptoms [ Time Frame: Baseline to Week 8 ]
    Assessed using Neuropathic Pain Symptom Inventory (NPSI) scores

  17. Reduction in pain [ Time Frame: Baseline to Week 8 ]
    By the pattern of sensory symptoms as defined using NPSI scores at baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01713426


  Hide Study Locations
Locations
Armenia
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
Austria
Site 114 Klinikum Klagenfurt Worthersee
Klagenfurt, Carynthia, Austria, 9020
Site 115 Medical University Innsbruck
Innsbruck, Tyrol, Austria, 6020
Site 116 Krankenhaus der Barmherzigen B
Graz, Austria, 8020
Site 111 AKH Universitatsklinik
Vienna, Austria, 1090
Site 112 Wilhelminenspital
Vienna, Austria, 1160
Belarus
Site 121 Vitebsk Regional Clinical Hospital # 1
Vitebsk, Belarus
Belgium
Site 131 UZ Brussels
Brussels, Belgium, 1090
Site 138 Cliniques Universitaires Saint
Bruxelles, Belgium, 1200
Site 134 Grand Hospital de Charleroi
Charleroi, Belgium, 6000
Site 137 Univ. Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Site 132 Ziekenhuis Oost-Limburg
Genk, Belgium, 3600
Site 136 UZ Pellenberg
Pellenberg, Belgium, 3212
Site 133 Heilig Hart Ziekenhuis
Roeselare, Belgium, 8800
Bulgaria
Site 142 UMHAT - Pleven
Pleven, Bulgaria, 5800
Site 141 Centre for Mental Health
Ruse, Bulgaria, 7000
Site 144 Tokuda Hospital Sofia
Sofia, Bulgaria, 1407
Site 146 MHAT Alexandrovska Hospital
Sofia, Bulgaria, 1431
Site 147 MHAT Sv. Ivan Rilski
Sofia, Bulgaria, 1431
Site 145 Military Medical Academy
Sofia, Bulgaria, 1606
Czechia
Site 151 Fakultni nemocnice Plzen
Plzen, Czechia, 305 99
Site 153 Klinika anesteziologie
Praha, Czechia, 128 08
Finland
Site 163 ORTON Invalidisaatio
Helsinki, Finland, 00280
Site 161 Finnmedi OY
Tampere, Finland, 33520
Site 162 Vassa Central Hospital
Vaasa, Finland, 65130
France
Site 171 Hospital Ambroise Pare
Boulogne Billancourt, France, 92100
Site 174 Hopital Neurologique Pierre W
Bron, France, 69677
Site 177 Hospital Roger Salengro CHRU
Lille, France, 59037
Site 175 CHU Caremeau
Nîmes, France, 30029
Site 172 Hospital Saint Antoine
Paris, France, 75012
Site 173 CHU Hopital Nord
Saint-Etienne, France, 42055
Site 176 CH Regional de Valence
Valence, France, 26953
Germany
Site 200 Prax S.Wolf u.B.Schütz Pal.med
Cottbus, Germany, 03050
Site 192 Universitätsklinikum Giessen
Gießen, Germany, 35385
Site 193 Universitätsklinikum Münster
Münster, Germany, 48149
Site 194 Schmerz Palliativznt Wiesbaden
Wiesbaden, Germany, 65189
Site 197 Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Greece
Site 204 Athens Naval Hospital
Athens, Greece, 115 21
Site 202 Hippokration General Hospital of Athens
Athens, Greece, 115 27
Site 201 Aretaieio University Hospital
Athens, Greece, 115 28
Site 203 Aretaieio/Maginio Hospital
Athens, Greece, 115 28
Hungary
Site 213 Semmelweis Egyetem Molekuláris Neurológiai Klinikai és Kutatási Központ
Budapest, Hungary, H-1083
Italy
Site 227 Azienda Ospedaliera Universita
Firenze, Italy, 50134
Site 222 A.O.U Ospedali Riuniti
Foggia, Italy, 71100
Site 225 Policlinico San Donato
Milano, Italy, 20097
Site 232 Ospedale Niguarda Ca' Granda
Milan, Italy, 20146
Site 221 FONDAZIONE S.MAUGERI I.R.C.C.S
Pavia, Italy, 27100
Site 228 Azienda Ospedaliero di Perugia
Perugia, Italy, 06156
Site 229 Azienda Ospedaliero di Perugia
Perugia, Italy, 06156
Site 231 Ospedale S. Chiara
Pisa, Italy, 56126
Site 226 Presidio Ospedale G.Mazzini
Teramo, Italy, 64100
Site 230 Azienda Ospedaliera SantaMaria
Terni, Italy, 05100
Site 223 AOU San Giovanni Battista
Torino, Italy, 10126
Poland
Site 244 Niepubliczny Zakład Opieki Zdr
Gdańsk, Poland, 80-286
Site 245 Poradnia Leczenia Bólu, Uniwer
Gdańsk, Poland, 80-952
Site 243 NZOZ Poradnia Leczenia Bólu
Gdynia, Poland, 81-049
Site 241 Tomasz Dąbrowski Śląskie Centr
Katowice, Poland, 40-084
Site 246 NZOZ Poradnia Leczenia Bolu Pr
Tychy, Poland, 43-100
Site 242 NZOZ Centrum Medyczne
Warszawa, Poland, 02-793
Portugal
Site 254 Hospital Fernando Fonseca
Amadora, Portugal, 2700
Site 252 Instituto Portuges de Oncologic
Lisboa, Portugal, 1099-023
Site 253 CHS - Hosp. S. Bernardo
Setúbal, Portugal, 2910-446
Romania
Site 261 Quantum Medical Center SRL
Bucuresti, Romania, 011422
Site 264 Spitalul Clinic Colentina
Bucuresti, Romania, 020125
Site 262 Spitalul Clinic Judetean de Ur
Constanta, Romania, 900591
Site 266 Spitalul Clinic de Urgenta "Pr
Iasi, Romania, 700309
Site 265 Spit Clin Judetean de Urgenta
Targu Mures, Romania, 540136
Site 263 Spitalul Clinic Judetean de Ur
Timisoara, Romania, 300736
Russian Federation
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
Slovakia
Site 282 Neurological surgery
Bratislava, Slovakia, 811 01
Site 281 AB-BA ambulancia
Bratislava, Slovakia, 85107
Site 283 SANERA, s.r.o.
Presov, Slovakia, 8001
Slovenia
Site 292 University Medical Centre Mari
Maribor, Slovenia, 2000
Spain
Site 301 Hospital General Universitario de Alicante
Alicante, Spain, 03010
Site 303 Hospital Universitario Virgen
Granada, Spain, 18014
Sweden
Site 313 SU/Östra
Göteborg, Sweden, 41685
Site 311 Karolinska University Hospital
Stockholm, Sweden, 14186
Site 312 Karolinska University Hospital
Stockholm, Sweden, 17176
Turkey
Site 321 Hacettepe University Medical Faculty Hospital
Ankara, Turkey, 06100
Site 325 Pamukkale University Medical Faculty Hospital
Denizli, Turkey, 20070
Site 326 Maramara University, Pendik Training and Research Hospital
Istanbul, Turkey, 34890
Site 323 Ege University Medical Faculty Hospital
Izmir, Turkey, 35100
Site 324 Dokuz Eylul University Medical Faculty Hospital
Izmir, Turkey, 35340
United Kingdom
Site 332 Gartnavel General Hospital
Glasgow, United Kingdom, G12 0YN
Site 334 Seacroft Hospital
Leeds, United Kingdom, LS14 6UH
Site 336 Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Site 331 The Walton Centre
Liverpool, United Kingdom, L9 7LJ
Site 333 St Thomas' Hospital
London, United Kingdom, SE1 7EH
Site 335 The Christies NHS Foundation
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Astellas Pharma Europe Ltd.
Investigators
Study Chair: Clinical Study Manager Astellas Pharma Europe Ltd.

Additional Information:
Responsible Party: Astellas Pharma Europe Ltd.
ClinicalTrials.gov Identifier: NCT01713426     History of Changes
Other Study ID Numbers: QTZ-EC-0004
2011-005872-41 ( EudraCT Number )
First Posted: October 24, 2012    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe Ltd. ):
Post herpetic neuralgia
Qutenza
NGX-4010
Peripheral Neuropathic Pain
Pregabalin

Additional relevant MeSH terms:
Neuralgia
Polyneuropathies
Neuralgia, Postherpetic
Peripheral Nerve Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Trauma, Nervous System
Wounds and Injuries
Pregabalin
Capsaicin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antipruritics
Dermatologic Agents