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Completed

NCT Number: NCT01524796

NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions in Denmark

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention. Non-interventional study

Other

No intervention. Non-interventional study

Other names: pregabalin (Lyrica)

Primary outcomes

  1. Change From Baseline In Average Pain Level At Month 3 Telephonic Interview

    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".

  2. Change From Baseline In Worst Pain Level At Month 3 Telephonic Interview

    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".

  3. Change From Baseline In Least Pain Level At Month 3 Telephonic Interview

    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".

Secondary outcomes

  1. Sleep Interference Scale Score

    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.

  2. Number of Participants With Categorical Scores On Patient Global Impression of Change (PGI-C)

    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.

  3. Health-related Quality of Life Scale Score

    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.

  4. Work Productivity and Activity Impairment (WPAI) Questionnaire

    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.

  5. Pregabalin Dose

    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.

  6. Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain Before Baseline, Month 1, 2, 3 Visit

    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.

  7. Number of Participants Using Other Pharmacological Pain Treatments For Peripheral Neuropathic Pain After Baseline Visit (Concomitant Medication)

    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.

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Acronym: NEP-TUNE

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 2, 2012
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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