Non-diabetic Painful Peripheral PolyneuropathyPhase 4ELEVATENCT01713426

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

A Phase 4 study testing Qutenza and Pregabalin in people with Non-diabetic Painful Peripheral Polyneuropathy and Postherpetic Neuralgia (PHN), run by Astellas Pharma Europe Ltd. at 98 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Non-diabetic Painful Peripheral Polyneuropathy, Postherpetic Neuralgia (PHN), Peripheral Nerve Injury (PNI)
What is being tested?: Qutenza and Pregabalin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 568 participants
Where: 98 sitesin 22 countries
Study dates: 11 Jul 2012to 26 Sep 2013
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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

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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

Trial locations and contacts

98 sites in 22 countries.

Country

City, postcode or hospital

98 sites in 22 countries

Italy11 sites

Site 227 Azienda Ospedaliera Universita
Florence, 50134
Site 222 A.O.U Ospedali Riuniti
Foggia, 71100
Site 232 Ospedale Niguarda Ca' Granda
Milan, 20146
Site 225 Policlinico San Donato
Milan, 20097
Site 221 FONDAZIONE S.MAUGERI I.R.C.C.S
Pavia, 27100
Site 228 Azienda Ospedaliero di Perugia
Perugia, 06156
Site 229 Azienda Ospedaliero di Perugia
Perugia, 06156
Site 231 Ospedale S. Chiara
Pisa, 56126
Site 226 Presidio Ospedale G.Mazzini
Teramo, 64100
Site 230 Azienda Ospedaliera SantaMaria
Terni, 05100
Site 223 AOU San Giovanni Battista
Torino, 10126

Other trials in Italy

Belgium7 sites

Site 131 UZ Brussels
Brussels, 1090
Site 138 Cliniques Universitaires Saint
Brussels, 1200
Site 134 Grand Hospital de Charleroi
Charleroi, 6000
Site 137 Univ. Ziekenhuis Antwerpen
Edegem, 2650
Site 132 Ziekenhuis Oost-Limburg
Genk, 3600
Site 136 UZ Pellenberg
Pellenberg, 3212
Site 133 Heilig Hart Ziekenhuis
Roeselare, 8800

Other trials in Belgium

France7 sites

Site 171 Hospital Ambroise Pare
Boulogne-Billancourt, 92100
Site 174 Hopital Neurologique Pierre W
Bron, 69677
Site 177 Hospital Roger Salengro CHRU
Lille, 59037
Site 175 CHU Caremeau
Nîmes, 30029
Site 172 Hospital Saint Antoine
Paris, 75012
Site 173 CHU Hopital Nord
Saint-Etienne, 42055
Site 176 CH Regional de Valence
Valence, 26953

Other trials in France

Russia7 sites

Site 271 First Moscow State Medical University named after I.M. Sechenov
Moscow
Site 272 City Clinical Hospital # 12
Moscow
Site 278 Semashko Regional Clinical Hospital
Nizhny Novgorod
Site 276 OOO Clinical Neurology Center
Novosibirsk
Site 273 Military Medical Academy
Saint Petersburg
Site 274 Saint-Petersburg State Medical University
Saint Petersburg
Site 277 Hospital №40 of Kurortniy
Saint Petersburg

Other trials in Russia

Bulgaria6 sites

Site 142 UMHAT - Pleven
Pleven, 5800
Site 141 Centre for Mental Health
Rousse, 7000
Site 144 Tokuda Hospital Sofia
Sofia, 1407
Site 146 MHAT Alexandrovska Hospital
Sofia, 1431
Site 147 MHAT Sv. Ivan Rilski
Sofia, 1431
Site 145 Military Medical Academy
Sofia, 1606

Other trials in Bulgaria

Poland6 sites

Site 244 Niepubliczny Zakład Opieki Zdr
Gdansk, 80-286
Site 245 Poradnia Leczenia Bólu, Uniwer
Gdansk, 80-952
Site 243 NZOZ Poradnia Leczenia Bólu
Gdynia, 81-049
Site 241 Tomasz Dąbrowski Śląskie Centr
Katowice, 40-084
Site 246 NZOZ Poradnia Leczenia Bolu Pr
Tychy, 43-100
Site 242 NZOZ Centrum Medyczne
Warsaw, 02-793

Other trials in Poland

Romania6 sites

Site 261 Quantum Medical Center SRL
Bucharest, 011422
Site 264 Spitalul Clinic Colentina
Bucharest, 020125
Site 262 Spitalul Clinic Judetean de Ur
Constanța, 900591
Site 266 Spitalul Clinic de Urgenta "Pr
Iași, 700309
Site 265 Spit Clin Judetean de Urgenta
Târgu Mureş, 540136
Site 263 Spitalul Clinic Judetean de Ur
Timișoara, 300736

Other trials in Romania

United Kingdom6 sites

Site 332 Gartnavel General Hospital
Glasgow, G12 0YN
Site 334 Seacroft Hospital
Leeds, LS14 6UH
Site 336 Leicester Royal Infirmary
Leicester, LE1 5WW
Site 331 The Walton Centre
Liverpool, L9 7LJ
Site 333 St Thomas' Hospital
London, SE1 7EH
Site 335 The Christies NHS Foundation
Manchester, M20 4BX

Other trials in United Kingdom

Austria5 sites

Site 116 Krankenhaus der Barmherzigen B
Graz, 8020
Site 115 Medical University Innsbruck
Innsbruck, Tyrol, 6020
Site 114 Klinikum Klagenfurt Worthersee
Klagenfurt, Carynthia, 9020
Site 111 AKH Universitatsklinik
Vienna, 1090
Site 112 Wilhelminenspital
Vienna, 1160

Other trials in Austria

Germany5 sites

Site 200 Prax S.Wolf u.B.Schütz Pal.med
Cottbus, 03050
Site 192 Universitätsklinikum Giessen
Giessen, 35385
Site 193 Universitätsklinikum Münster
Münster, 48149
Site 194 Schmerz Palliativznt Wiesbaden
Wiesbaden, 65189
Site 197 Universitätsklinikum Würzburg
Würzburg, 97080

Other trials in Germany

Turkey (Türkiye)5 sites

Site 321 Hacettepe University Medical Faculty Hospital
Ankara, 06100
Site 325 Pamukkale University Medical Faculty Hospital
Denizli, 20070
Site 326 Maramara University, Pendik Training and Research Hospital
Istanbul, 34890
Site 323 Ege University Medical Faculty Hospital
Izmir, 35100
Site 324 Dokuz Eylul University Medical Faculty Hospital
Izmir, 35340

Other trials in Turkey (Türkiye)

Armenia4 sites

Site 101 Medical Union 2
Yerevan
Site 102 Medical Center Erebuni
Yerevan
Site 103 Scientific research Institute of physiotherapy
Yerevan
Site 104 Medical Center "Surb Nerses Mets"
Yerevan

Other trials in Armenia

Greece4 sites

Site 204 Athens Naval Hospital
Athens, 115 21
Site 202 Hippokration General Hospital of Athens
Athens, 115 27
Site 201 Aretaieio University Hospital
Athens, 115 28
Site 203 Aretaieio/Maginio Hospital
Athens, 115 28

Other trials in Greece

Finland3 sites

Site 163 ORTON Invalidisaatio
Helsinki, 00280
Site 161 Finnmedi OY
Tampere, 33520
Site 162 Vassa Central Hospital
Vaasa, 65130

Other trials in Finland

Portugal3 sites

Site 254 Hospital Fernando Fonseca
Amadora, 2700
Site 252 Instituto Portuges de Oncologic
Lisbon, 1099-023
Site 253 CHS - Hosp. S. Bernardo
Setúbal, 2910-446

Other trials in Portugal

Slovakia3 sites

Site 282 Neurological surgery
Bratislava, 811 01
Site 281 AB-BA ambulancia
Bratislava, 85107
Site 283 SANERA, s.r.o.
Prešov, 8001

Other trials in Slovakia

Sweden3 sites

Site 313 SU/Östra
Gothenburg, 41685
Site 311 Karolinska University Hospital
Stockholm, 14186
Site 312 Karolinska University Hospital
Stockholm, 17176

Other trials in Sweden

Czechia2 sites

Site 151 Fakultni nemocnice Plzen
Pilsen, 305 99
Site 153 Klinika anesteziologie
Prague, 128 08

Other trials in Czechia

Spain2 sites

Site 301 Hospital General Universitario de Alicante
Alicante, 03010
Site 303 Hospital Universitario Virgen
Granada, 18014

Other trials in Spain

Belarus1 site

Site 121 Vitebsk Regional Clinical Hospital # 1
Vitebsk

Other trials in Belarus

Hungary1 site

Site 213 Semmelweis Egyetem Molekuláris Neurológiai Klinikai és Kutatási Központ
Budapest, H-1083

Other trials in Hungary

Slovenia1 site

Site 292 University Medical Centre Mari
Maribor, 2000

Other trials in Slovenia

About this study

Official title: Qutenza Versus Pregabalin in Subjects With Peripheral Neuropathic Pain: an Open-label, Randomized, Multicenter, Non-inferiority Efficacy and Tolerability 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)
Being tested: Qutenza, Pregabalin
Keywords: Post herpetic neuralgia, Qutenza, NGX-4010, Peripheral Neuropathic Pain, Pregabalin
Medical subject headings: Neuralgia, Postherpetic, Peripheral Nerve Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

QutenzaDrug
Also called Capsaicin
Cutaneous patch
PregabalinDrug
Oral capsule

Study groups in NCT01713426
Study group	Role	What they receive
Qutenza	Experimental	Cutaneous patch Receives: Drug: Qutenza
Pregabalin	Active comparator	Oral capsule Receives: Drug: Pregabalin

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline and week 8

Secondary outcomes (17)

Proportion of subjects in each arm who achieve "optimal Therapeutic effect"
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
Measured: Baseline and week 8
Proportion of subjects who achieve at least a 30% decrease in the "average pain for the past 24 hours"
NPRS score from baseline to the mean of all scores recorded between Week 1 (Day 8) and Week 8 (Day 57)
Measured: Baseline to Week 8
Proportion of subjects who achieve at least a 50% decrease in the "average pain for the past 24 hours"
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)
Measured: Baseline to Week 8
Absolute and percent change in "average pain for the past 24 hours"
NPRS score from baseline to Week 8, and from baseline to the mean of all scores recorded between Weeks 1 to 8
Measured: Baseline to Week 8
Time to onset of pain relief (in days)
Assessed by at least a 30% reduction in "average pain for the past 24 hours" NPRS score
Measured: Up to 8 weeks
Overall subject status using Patient Global Impression of Change (PGIC) questionnaire
Measured: At Weeks 4 and 8
Change in the Medical Outcomes Study (MOS) 6-Item Cognitive Functioning Scale
Measured: Baseline to Week 8
MOS - Sleep Scale
Measured: Baseline to Weeks 4 and 8
Change in the EQ-5D-5L (Euroqol-5 dimensions-5 levels) total score
Measured: Baseline to Week 8
Treatment satisfaction
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
Measured: Baseline to Weeks 4 and 8
Treatment satisfaction - continuance of treatment
As assessed by willingness to continue treatment at Week 8
Measured: Week 8
Time to reach optimal maintenance dose for pregabalin
Measured: Baseline to Week 8
Healthcare Resource use
Number of contacts with health professionals
Measured: Baseline to Week 8
Tolerability (Assessed by the number, severity and duration of ADRs)
Collected as self-rated health-related complaints by the subject and then medically confirmed and causality assigned by the investigator
Measured: Baseline to Week 8
Change in intensity and area of allodynia
Measured: Baseline to Week 8
Changes in sensory symptoms
Assessed using Neuropathic Pain Symptom Inventory (NPSI) scores
Measured: Baseline to Week 8
Reduction in pain
By the pattern of sensory symptoms as defined using NPSI scores at baseline.
Measured: Baseline to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jul 201226 Sep 2013

First posted24 Oct 2012 (estimated)
Study start11 Jul 2012
Primary completion26 Sep 2013
Study completion26 Sep 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non-diabetic Painful Peripheral PolyneuropathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 568 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01713426
Sponsor's protocol ID: QTZ-EC-0004
Other IDs: 2011-005872-41
Acronym: ELEVATE
Status last verified: Apr 2018
First submitted: 22 Oct 2012
Last updated: 23 Apr 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Publications

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.
PubMed 34554688

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Qutenza Versus Pregabalin in Subjects With Peripheral Neuropathic Pain: an Open-label, Randomized, Multicenter, Non-inferiority Efficacy and Tolerability Study
ClinicalTrials.gov ID: NCT01713426
Acronym / sponsor ID: ELEVATE / QTZ-EC-0004
Conditions: Non-diabetic Painful Peripheral Polyneuropathy, Postherpetic Neuralgia (PHN), Peripheral Nerve Injury (PNI)
Keywords: Post herpetic neuralgia, Qutenza, NGX-4010, Peripheral Neuropathic Pain, Pregabalin
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 568 participants (actual)
Lead sponsor: Astellas Pharma Europe Ltd.Industry (pharma, biotech, devices)
Study start: 11 Jul 2012 (actual)
Primary completion: 26 Sep 2013 (actual)
Study completion: 26 Sep 2013 (actual)
First posted: 24 Oct 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will include subjects suffering from Postherpetic Neuralgia, Peripheral Nerve Injury or Non Diabetic peripheral polyneuropathy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Qutenza	Experimental	Drug: QutenzaCutaneous patch
Pregabalin	Active comparator	Drug: PregabalinOral capsule

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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:
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

Key exclusion criteria (24 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
QutenzaAlso: CapsaicinCutaneous patch	Drug	Qutenza
PregabalinOral capsule	Drug	Pregabalin

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
Time frame: Baseline and week 8

17 secondary outcomes

Proportion of subjects in each arm who achieve "optimal Therapeutic effect"
Time frame: Baseline and week 8
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
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
Absolute and percent change in "average pain for the past 24 hours"
Time frame: Baseline to Week 8
Time to onset of pain relief (in days)
Time frame: Up to 8 weeks
Overall subject status using Patient Global Impression of Change (PGIC) questionnaire
Time frame: At Weeks 4 and 8
Change in the Medical Outcomes Study (MOS) 6-Item Cognitive Functioning Scale
Time frame: Baseline to Week 8
MOS - Sleep Scale
Time frame: Baseline to Weeks 4 and 8
Change in the EQ-5D-5L (Euroqol-5 dimensions-5 levels) total score
Time frame: Baseline to Week 8
Treatment satisfaction
Time frame: Baseline to Weeks 4 and 8
Treatment satisfaction - continuance of treatment
Time frame: Week 8
Time to reach optimal maintenance dose for pregabalin
Time frame: Baseline to Week 8
Healthcare Resource use
Time frame: Baseline to Week 8
Tolerability (Assessed by the number, severity and duration of ADRs)
Time frame: Baseline to Week 8
Change in intensity and area of allodynia
Time frame: Baseline to Week 8
Changes in sensory symptoms
Time frame: Baseline to Week 8
Reduction in pain
Time frame: Baseline to Week 8

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
Derived from this study: PubMed 34554688Viel 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.
Link to results on EudraCTLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Study Manager study chair

Astellas Pharma Europe Ltd.

98 sites in 22 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in Italy, Belgium, France, Russia, Bulgaria and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Baseline and week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01713426, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.