NEP-TUNE: Neuropathic Pain - Treatment With Pregabalin Under Real-life Conditions in Denmark
NCT01524796
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- 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.
- 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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| 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 | 128 | |||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ) | |||
| Study Sponsor | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2015 | |||