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

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NCT01524796

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Peripheral Neuropathic Pain
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Subjects not consenting to participate.


- Subjects that at study inclusion (baseline) are on treatment with pregabalin for
generalized anxiety or epilepsy.

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Advanced Information
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 CenterPfizer
PRS Account Pfizer
Verification Date March 2015