N/A
N=128
NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions in Denmark
Peripheral Neuropathic Pain
Bottom Line
View on ClinicalTrials.gov: NCT01524796 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcome: Primary: Change From Baseline In Average Pain Level At Month 3 Telephonic Interview — 6.7; -2.2 Units on a scale — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention. Non-interventional study (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline In Average Pain Level At Month 3 Telephonic Interview |
6.7; -2.2 | <0.001 sig |
| PRIMARY Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview |
8.4; -2.1 | <0.001 sig |
| PRIMARY Change From Baseline In Least Pain Level At Month 3 Telephonic Interview |
4.1; -1.5 | <0.001 sig |
| SECONDARY Sleep Interference Scale Score |
5.3; 4.2; 4.0; 4.3; 2.3 | — |
| SECONDARY Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C) |
18; 35; 26; 4; 3; 0 | — |
| SECONDARY Health-related Quality of Life Scale Score |
0.47; 0.58; 0.58; 0.63 | — |
| SECONDARY Work Productivity and Activity Impairment (WPAI) Questionnaire |
28.4; 28.7; 17.8; 29.9; 70.0; 58.2 | — |
| SECONDARY Pregabalin Dose |
107.4; 123.4; 164.6; 240.7; 81.5; 148.4 | — |
| SECONDARY Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit |
5; 14; 33; 25; 35; 18 | — |
| SECONDARY Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication) |
25; 12; 6; 16; 24; 17 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Subjects aged 18 years or over.
- Subjects diagnosed with peripheral neuropathic pain.
- Subjects that independently of the study and before consideration for observation in the study have been prescribed pregabalin for treatment of peripheral neuropathic pain either.
- for the first time ('first prescription patients') or
- that have not used pregabalin within the previous 6 months but are prescribed pregabalin again ('re-treatment patients')
- Subjects that haven't taken the first dose of the prescribed pregabalin yet.
Exclusion Criteria
- Subjects not consenting to participate.
- Subjects that at study inclusion (baseline) are on treatment with pregabalin for generalized anxiety or epilepsy.
Data sourced from ClinicalTrials.gov (NCT01524796). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.