No intervention. Non-interventional study
OtherNo intervention. Non-interventional study
Other names: pregabalin (Lyrica)
NCT Number: NCT01524796
Observational study to assess the effectiveness and use of pregabalin (Lyrica) in the treatment of patients with peripheral neuropathic pain in real-life daily clinical practice.
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Notify Me18 year and older
All sexes
Observational
General practitioners and specialists participate in the study. When a subject, independently of the study and before consideration for observation in the study has been prescribed pregabalin for treatment of peripheral NeP, the subject can (before first dose of pregabalin is taken) be included in the observational program.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention. Non-interventional study
Other names: pregabalin (Lyrica)
Time frame: Baseline, Month 3 Telephonic Interview
Pain was assessed on an 11-point numeric rating scale (NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Time frame: Baseline, Month 3 Telephonic Interview
Pain was assessed on an 11-point NRS where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Time frame: Baseline, Month 3 Telephonic Interview
Pain was assessed on an 11-point NRS where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Time frame: Baseline, Month 1, 2, 3, Month 3 telephonic interview
Sleep Interference was assessed on an 11-point Sleep Numeric Rating Scale (NRS-11) where a score of 0 indicated "pain did not interfere with sleep" and a score of 10 indicated "pain completely interfered with sleep". Here, "n" signifies "Number of participants" for Baseline and Month 3 telephone interview whereas "n" signifies "number of observations" for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Time frame: Month 3 telephonic interview
PGIC: participant rated instrument to measure participant's change in overall status on a 7-point scale; range from 1 (very much improved) to 7 (very much worse). Number of participants in each category are reported.
Time frame: Baseline, Month 1, 2, 3
Health-related Quality of Life was measured using Euro Quality of Life-5 dimensions (EQ-5D) scale. EQ-5D is a standardized generic instrument to assess health-related quality of life on 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). The scale rates current participant's health state on a scale from 0 (worst imaginable health state) to 1 (best imaginable health state); higher scores indicate a better health state. Here, "n" signifies "Number of participants" for Baseline whereas "n" signifies "number of observations" for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Time frame: Baseline, Month 1, 2, 3
WPAI questionnaire assess work productivity and impairment. It is a patient-rated, six-item questionnaire regarding current employment, hours missed and actually worked, and degree to which a specified health problem affected work productivity and regular activities over the past seven days. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, "n" signifies "Number of participants" for Baseline whereas "n" signifies "number of observations" for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Time frame: After Baseline Visit; Prior to Month 1, 2, 3, Month 3 Telephonic Interview; After Month 1, 2, 3, Month 3 Telephonic Interview
Here, "n" signifies "Number of participants" for Baseline and Month 3 telephone interview whereas "n" signifies "number of observations" for Month 1, 2 and 3 because a participant could have had multiple visits during Month 1, 2 and 3 as this was a non-interventional study with no scheduled study visits, except Baseline visit and the Month 3 telephone interview.
Time frame: Before Baseline, Month 1, 2, 3 Visit
Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.
Time frame: After Baseline, Month 1, 2, 3 visit
Pharmacological treatments included tricyclic antidepressants (TCA), gabapentin, non-steroidal anti-inflammatory drugs (NSAIDs), weak opioids, strong opioids, serotonin-norepinephrine reuptake inhibitors (SNRIs), lidocaine or capsaicin patch (L/C) and other (parcetamol containing drugs, xylocain gel or kinin). Participants may have used more than one pharmacological pain treatments and may be presented in more than 1 category.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Industry
Acronym: NEP-TUNE
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