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Trial record 1 of 1 for:    NCT01524796
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NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions in Denmark (NEP-TUNE)

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ClinicalTrials.gov Identifier: NCT01524796
Recruitment Status : Completed
First Posted : February 2, 2012
Results First Posted : March 31, 2015
Last Update Posted : March 31, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date December 12, 2011
First Posted Date February 2, 2012
Results First Submitted Date March 11, 2015
Results First Posted Date March 31, 2015
Last Update Posted Date March 31, 2015
Study Start Date January 2012
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 25, 2015)
  • 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".
  • 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".
  • 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".
Original Primary Outcome Measures
 (submitted: January 30, 2012)
  • Change from baseline in average pain level during the past week. [ Time Frame: Baseline up to month 3 ]
  • Change from baseline in worst pain level during the past week. [ Time Frame: Baseline up to month 3 ]
  • Change from baseline in least pain level during the past week. [ Time Frame: Baseline up to month 3 ]
Change History
Current Secondary Outcome Measures
 (submitted: March 25, 2015)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: January 30, 2012)
  • Change from baseline in pain-related sleep interference during the past week. [ Time Frame: Baseline up to month 3 ]
  • Patient's Global Impression of Change (PGIC). [ Time Frame: Baseline up to month 3 ]
  • Health-related Quality of Life (EQ-5D). [ Time Frame: Baseline up to month 3 ]
  • Work Productivity and Activity Impairment (WPAI) questionnaire. [ Time Frame: Baseline up to month 3 ]
  • Pregabalin dose. [ Time Frame: Baseline up to month 3 ]
  • Use of other pharmacological pain treatment for peripheral neuropathy (NeP). [ Time Frame: Baseline up to month 3 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Peripheral Neuropathic Pain
Intervention Other: No intervention. Non-interventional study
No intervention. Non-interventional study
Other Name: pregabalin (Lyrica)
Study Groups/Cohorts Patients with peripheral neuropathic pain treated with Lyrica
Intervention: Other: No intervention. Non-interventional study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 15, 2014)
128
Original Estimated Enrollment
 (submitted: January 30, 2012)
600
Actual Study Completion Date March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01524796
Other Study ID Numbers A0081292
NEP-TUNE ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2015