NCT01524796

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2011

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 31, 2015

Completed
Last Updated

January 28, 2021

Status Verified

March 1, 2015

Enrollment Period

2.2 years

First QC Date

December 12, 2011

Results QC Date

March 11, 2015

Last Update Submit

January 26, 2021

Conditions

Peripheral Neuropathic Pain

Keywords

Real-lifenon-interventionalobservationalperipheral neuropathic painLyricapregabalin

Outcome Measures

Primary Outcomes (3)

  • Change From Baseline In Average Pain Level At 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".

    Baseline, Month 3 Telephonic Interview

  • Change From Baseline In Worst Pain Level At 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".

    Baseline, Month 3 Telephonic Interview

  • Change From Baseline In Least Pain Level At 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".

    Baseline, Month 3 Telephonic Interview

Secondary Outcomes (7)

  • Sleep Interference Scale Score

    Baseline, Month 1, 2, 3, Month 3 telephonic interview

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

    Month 3 telephonic interview

  • Health-related Quality of Life Scale Score

    Baseline, Month 1, 2, 3

  • Work Productivity and Activity Impairment (WPAI) Questionnaire

    Baseline, Month 1, 2, 3

  • Pregabalin Dose

    After Baseline Visit; Prior to Month 1, 2, 3, Month 3 Telephonic Interview; After Month 1, 2, 3, Month 3 Telephonic Interview

  • +2 more secondary outcomes

Study Arms (1)

Patients with peripheral neuropathic pain treated with Lyrica

Other: No intervention. Non-interventional study

Interventions

No intervention. Non-interventional studyOTHER

No intervention. Non-interventional study

Also known as: pregabalin (Lyrica)
Patients with peripheral neuropathic pain treated with Lyrica

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects not consenting to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

Pregabalin

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
18007181021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2011

First Posted

February 2, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

January 28, 2021

Results First Posted

March 31, 2015

Record last verified: 2015-03