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

NCT ID: NCT01524796

Last Updated: 2021-01-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Peripheral Neuropathic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with peripheral neuropathic pain treated with Lyrica

No intervention. Non-interventional study

Intervention Type OTHER

No intervention. Non-interventional study

Interventions

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No intervention. Non-interventional study

No intervention. Non-interventional study

Intervention Type OTHER

Other Intervention Names

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pregabalin (Lyrica)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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Other Identifiers

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NEP-TUNE

Identifier Type: OTHER

Identifier Source: secondary_id

A0081292

Identifier Type: -

Identifier Source: org_study_id

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