Clinical trial NCT01524796: NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions in Denmark
Official title: NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions In Denmark
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Neuropathic Pain
Keywords: Real-life
non-interventional
observational
peripheral neuropathic pain
Lyrica
pregabalin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-02-02
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed description: 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.

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.

  1. for the first time ('first prescription patients') or
  2. 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.

Primary outcomes:
measure: Change From Baseline In Average Pain Level At Month 3 Telephonic Interview
timeFrame: Baseline, Month 3 Telephonic Interview
measure: Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview
timeFrame: Baseline, Month 3 Telephonic Interview
measure: Change From Baseline In Least Pain Level At Month 3 Telephonic Interview
timeFrame: Baseline, Month 3 Telephonic Interview
Secondary outcomes:
measure: Sleep Interference Scale Score
timeFrame: Baseline, Month 1, 2, 3, Month 3 telephonic interview
measure: Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)
timeFrame: Month 3 telephonic interview
measure: Health-related Quality of Life Scale Score
timeFrame: Baseline, Month 1, 2, 3
measure: Work Productivity and Activity Impairment (WPAI) Questionnaire
timeFrame: Baseline, Month 1, 2, 3
measure: Pregabalin Dose
timeFrame: After Baseline Visit; Prior to Month 1, 2, 3, Month 3 Telephonic Interview; After Month 1, 2, 3, Month 3 Telephonic Interview
measure: Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit
timeFrame: Before Baseline, Month 1, 2, 3 Visit
measure: Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)
timeFrame: After Baseline, Month 1, 2, 3 visit
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: