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

NCT01713426 | Completed Phase 4

• 2 other identifiers: QTZ-EC-00042011-005872-41
• Study Type: interventional
• Target: 568
• Locations: 20 countries
• Sites: 94

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.

Conditions

Non-diabetic Painful Peripheral Polyneuropathy; Postherpetic Neuralgia (PHN); Peripheral Nerve Injury (PNI)

Keywords

Post herpetic neuralgia; Qutenza; NGX-4010; Peripheral Neuropathic Pain; Pregabalin

Outcome Measures

Primary Outcomes (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

  Baseline and week 8

Secondary Outcomes (17)

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

  Baseline and week 8

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

  Baseline to Week 8

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

  Baseline to Week 8

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

  Baseline to Week 8

• Time to onset of pain relief (in days)

  Up to 8 weeks

Study Arms (2)

Qutenza

EXPERIMENTAL

Cutaneous patch

Drug: Qutenza

Pregabalin

ACTIVE COMPARATOR

Oral capsule

Drug: Pregabalin

Interventions

Qutenza DRUG

Cutaneous patch

Also known as: Capsaicin

Qutenza

Pregabalin DRUG

Oral capsule

Pregabalin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Documented diagnosis of probable or definite PNP
• \. Localized and well-defined area of PNP, suitable for treatment with QUTENZA
• \. 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
• \. 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
• \. Intact, non-irritated, dry skin over the painful area(s) to be treated
• \. 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
• \. Subject is willing to receive pregabalin or QUTENZA as part of the trial
• \. 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

You may not qualify if:

• \. 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
• \. Complex Regional Pain Syndrome (CRPS, Type I or II)
• \. Neuropathic pain related to previously administered radiotherapy, diabetes mellitus or HIV-AN
• \. Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes
• \. Severe loss of heat sensation in the painful area, indicative of C-fiber denervation
• \. Reported daily pain score of 10 on the NPRS for at least 4 days during the Screening Period
• \. Past or current history of diabetes mellitus
• \. 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
• \. Creatinine clearance (CLcr) \< 60mL/min according to the Cockcroft-Gault formula
• \. Untreated ongoing generalized anxiety disorder according to DSM-IV or ICD-10 criteria
• \. Severe ongoing depression according to DSM-IV or ICD-10 criteria
• \. 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
• \. Planned elective surgery during the trial
• \. Changes to stable neuropathic pain background medication in the 4 weeks prior to the Baseline Visit
• \. Any prior receipt of QUTENZA patches, including blinded patches administered as part of a clinical trial

Sponsors & Collaborators

• Astellas Pharma Europe Ltd.: lead

Study Sites (98)

Site 101 Medical Union 2

Yerevan, Armenia

Location

Site 102 Medical Center Erebuni

Yerevan, Armenia

Location

Site 103 Scientific research Institute of physiotherapy

Yerevan, Armenia

Location

Site 104 Medical Center "Surb Nerses Mets"

Yerevan, Armenia

Location

Site 114 Klinikum Klagenfurt Worthersee

Klagenfurt, Carynthia, 9020, Austria

Location

Site 115 Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Site 116 Krankenhaus der Barmherzigen B

Graz, 8020, Austria

Location

Site 111 AKH Universitatsklinik

Vienna, 1090, Austria

Location

Site 112 Wilhelminenspital

Vienna, 1160, Austria

Location

Site 121 Vitebsk Regional Clinical Hospital # 1

Vitebsk, Belarus

Location

Site 131 UZ Brussels

Brussels, 1090, Belgium

Location

Site 138 Cliniques Universitaires Saint

Brussels, 1200, Belgium

Location

Site 134 Grand Hospital de Charleroi

Charleroi, 6000, Belgium

Location

Site 137 Univ. Ziekenhuis Antwerpen

Edegem, 2650, Belgium

Location

Site 132 Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

Site 136 UZ Pellenberg

Pellenberg, 3212, Belgium

Location

Site 133 Heilig Hart Ziekenhuis

Roeselare, 8800, Belgium

Location

Site 142 UMHAT - Pleven

Pleven, 5800, Bulgaria

Location

Site 141 Centre for Mental Health

Rousse, 7000, Bulgaria

Location

Site 144 Tokuda Hospital Sofia

Sofia, 1407, Bulgaria

Location

Site 146 MHAT Alexandrovska Hospital

Sofia, 1431, Bulgaria

Location

Site 147 MHAT Sv. Ivan Rilski

Sofia, 1431, Bulgaria

Location

Site 145 Military Medical Academy

Sofia, 1606, Bulgaria

Location

Site 151 Fakultni nemocnice Plzen

Pilsen, 305 99, Czechia

Location

Site 153 Klinika anesteziologie

Prague, 128 08, Czechia

Location

Site 163 ORTON Invalidisaatio

Helsinki, 00280, Finland

Location

Site 161 Finnmedi OY

Tampere, 33520, Finland

Location

Site 162 Vassa Central Hospital

Vaasa, 65130, Finland

Location

Site 171 Hospital Ambroise Pare

Boulogne-Billancourt, 92100, France

Location

Site 174 Hopital Neurologique Pierre W

Bron, 69677, France

Location

Site 177 Hospital Roger Salengro CHRU

Lille, 59037, France

Location

Site 175 CHU Caremeau

Nîmes, 30029, France

Location

Site 172 Hospital Saint Antoine

Paris, 75012, France

Location

Site 173 CHU Hopital Nord

Saint-Etienne, 42055, France

Location

Site 176 CH Regional de Valence

Valence, 26953, France

Location

Site 200 Prax S.Wolf u.B.Schütz Pal.med

Cottbus, 03050, Germany

Location

Site 192 Universitätsklinikum Giessen

Giessen, 35385, Germany

Location

Site 193 Universitätsklinikum Münster

Münster, 48149, Germany

Location

Site 194 Schmerz Palliativznt Wiesbaden

Wiesbaden, 65189, Germany

Location

Site 197 Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Site 204 Athens Naval Hospital

Athens, 115 21, Greece

Location

Site 202 Hippokration General Hospital of Athens

Athens, 115 27, Greece

Location

Site 201 Aretaieio University Hospital

Athens, 115 28, Greece

Location

Site 203 Aretaieio/Maginio Hospital

Athens, 115 28, Greece

Location

Site 213 Semmelweis Egyetem Molekuláris Neurológiai Klinikai és Kutatási Központ

Budapest, H-1083, Hungary

Location

Site 227 Azienda Ospedaliera Universita

Florence, 50134, Italy

Location

Site 222 A.O.U Ospedali Riuniti

Foggia, 71100, Italy

Location

Site 232 Ospedale Niguarda Ca' Granda

Milan, 20146, Italy

Location

Site 225 Policlinico San Donato

Milan, 20097, Italy

Location

Site 221 FONDAZIONE S.MAUGERI I.R.C.C.S

Pavia, 27100, Italy

Location

Site 228 Azienda Ospedaliero di Perugia

Perugia, 06156, Italy

Location

Site 229 Azienda Ospedaliero di Perugia

Perugia, 06156, Italy

Location

Site 231 Ospedale S. Chiara

Pisa, 56126, Italy

Location

Site 226 Presidio Ospedale G.Mazzini

Teramo, 64100, Italy

Location

Site 230 Azienda Ospedaliera SantaMaria

Terni, 05100, Italy

Location

Site 223 AOU San Giovanni Battista

Torino, 10126, Italy

Location

Site 244 Niepubliczny Zakład Opieki Zdr

Gdansk, 80-286, Poland

Location

Site 245 Poradnia Leczenia Bólu, Uniwer

Gdansk, 80-952, Poland

Location

Site 243 NZOZ Poradnia Leczenia Bólu

Gdynia, 81-049, Poland

Location

Site 241 Tomasz Dąbrowski Śląskie Centr

Katowice, 40-084, Poland

Location

Site 246 NZOZ Poradnia Leczenia Bolu Pr

Tychy, 43-100, Poland

Location

Site 242 NZOZ Centrum Medyczne

Warsaw, 02-793, Poland

Location

Site 254 Hospital Fernando Fonseca

Amadora, 2700, Portugal

Location

Site 252 Instituto Portuges de Oncologic

Lisbon, 1099-023, Portugal

Location

Site 253 CHS - Hosp. S. Bernardo

Setúbal, 2910-446, Portugal

Location

Site 261 Quantum Medical Center SRL

Bucharest, 011422, Romania

Location

Site 264 Spitalul Clinic Colentina

Bucharest, 020125, Romania

Location

Site 262 Spitalul Clinic Judetean de Ur

Constanța, 900591, Romania

Location

Site 266 Spitalul Clinic de Urgenta "Pr

Iași, 700309, Romania

Location

Site 265 Spit Clin Judetean de Urgenta

Târgu Mureş, 540136, Romania

Location

Site 263 Spitalul Clinic Judetean de Ur

Timișoara, 300736, Romania

Location

Site 271 First Moscow State Medical University named after I.M. Sechenov

Moscow, Russia

Location

Site 272 City Clinical Hospital # 12

Moscow, Russia

Location

Site 278 Semashko Regional Clinical Hospital

Nizhny Novgorod, Russia

Location

Site 276 OOO Clinical Neurology Center

Novosibirsk, Russia

Location

Site 273 Military Medical Academy

Saint Petersburg, Russia

Location

Site 274 Saint-Petersburg State Medical University

Saint Petersburg, Russia

Location

Site 277 Hospital №40 of Kurortniy

Saint Petersburg, Russia

Location

Site 282 Neurological surgery

Bratislava, 811 01, Slovakia

Location

Site 281 AB-BA ambulancia

Bratislava, 85107, Slovakia

Location

Site 283 SANERA, s.r.o.

Prešov, 8001, Slovakia

Location

Site 292 University Medical Centre Mari

Maribor, 2000, Slovenia

Location

Site 301 Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Site 303 Hospital Universitario Virgen

Granada, 18014, Spain

Location

Site 313 SU/Östra

Gothenburg, 41685, Sweden

Location

Site 311 Karolinska University Hospital

Stockholm, 14186, Sweden

Location

Site 312 Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Site 321 Hacettepe University Medical Faculty Hospital

Ankara, 06100, Turkey (Türkiye)

Location

Site 325 Pamukkale University Medical Faculty Hospital

Denizli, 20070, Turkey (Türkiye)

Location

Site 326 Maramara University, Pendik Training and Research Hospital

Istanbul, 34890, Turkey (Türkiye)

Location

Site 323 Ege University Medical Faculty Hospital

Izmir, 35100, Turkey (Türkiye)

Location

Site 324 Dokuz Eylul University Medical Faculty Hospital

Izmir, 35340, Turkey (Türkiye)

Location

Site 332 Gartnavel General Hospital

Glasgow, G12 0YN, United Kingdom

Location

Site 334 Seacroft Hospital

Leeds, LS14 6UH, United Kingdom

Location

Site 336 Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Site 331 The Walton Centre

Liverpool, L9 7LJ, United Kingdom

Location

Site 333 St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

Site 335 The Christies NHS Foundation

Manchester, M20 4BX, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34554688 DERIVED

Related Links

• Link to results on EudraCT
• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Neuralgia, Postherpetic; Peripheral Nerve Injuries

Interventions

Capsaicin; Pregabalin

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Clinical Study Manager

  Astellas Pharma Europe Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2012
• First Posted: October 24, 2012
• Study Start: July 11, 2012
• Primary Completion: September 26, 2013
• Study Completion: September 26, 2013
• Last Updated: April 23, 2018

Record last verified: 2018-04

Locations

CZ (2); PT (3); RU (7); SL (1); RO (6); HU (1); PL (6); GR (4); FI (3); FR (7); AR (4); ES (2); AU (5); SE (3); TU (5); BE (7); DE (5); BU (6); IT (11); GB (6)