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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
568
Cutaneous patch
Oral capsule
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 114 Klinikum Klagenfurt Worthersee
Klagenfurt, Carynthia, Austria
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
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
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"
NPRS score from baseline to the mean of all scores recorded between Week 1 (Day 8) and Week 8 (Day 57)
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"
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)
Time frame: 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
Time frame: 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
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
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
Time frame: Baseline to Weeks 4 and 8
Treatment satisfaction - continuance of treatment
As assessed by willingness to continue treatment at Week 8
Time frame: Week 8
Time to reach optimal maintenance dose for pregabalin
Time frame: Baseline to Week 8
Healthcare Resource use
Number of contacts with health professionals
Time frame: 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
Time frame: Baseline to Week 8
Change in intensity and area of allodynia
Time frame: Baseline to Week 8
Changes in sensory symptoms
Assessed using Neuropathic Pain Symptom Inventory (NPSI) scores
Time frame: Baseline to Week 8
Reduction in pain
By the pattern of sensory symptoms as defined using NPSI scores at baseline.
Time frame: Baseline to Week 8
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Site 115 Medical University Innsbruck
Innsbruck, Tyrol, Austria
Site 116 Krankenhaus der Barmherzigen B
Graz, Austria
Site 111 AKH Universitatsklinik
Vienna, Austria
Site 112 Wilhelminenspital
Vienna, Austria
Site 121 Vitebsk Regional Clinical Hospital # 1
Vitebsk, Belarus
...and 88 more locations