search
Back to results

To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Postherpetic Neuralgia.

Primary Purpose

Neuralgia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pregabalin
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Must have met the inclusion criteria for preceding double-blind BID study in postherpetic neuralgia Must have received pregabalin/placebo under double-blind conditions for a minimum of 3 weeks. Exclusion Criteria: Patients cannot participate if they experienced a serious adverse event during preceding double-blind BID study which was determined to be related to the study medication.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Safety Efficacy

    Secondary Outcome Measures

    Full Information

    First Posted
    September 6, 2005
    Last Updated
    December 20, 2006
    Sponsor
    Pfizer
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00150436
    Brief Title
    To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Postherpetic Neuralgia.
    Official Title
    An Open-Label Extension Safety and Efficacy Study of Pregabalin in Patients With Postherpetic Neuralgia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    July 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pfizer

    4. Oversight

    5. Study Description

    Brief Summary
    To evaluate long-term safety and efficacy of pregabalin in patients with postherpetic neuralgia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neuralgia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    276 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Pregabalin
    Primary Outcome Measure Information:
    Title
    Safety Efficacy

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Must have met the inclusion criteria for preceding double-blind BID study in postherpetic neuralgia Must have received pregabalin/placebo under double-blind conditions for a minimum of 3 weeks. Exclusion Criteria: Patients cannot participate if they experienced a serious adverse event during preceding double-blind BID study which was determined to be related to the study medication.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Pfizer CT.gov Call Center
    Organizational Affiliation
    Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    To Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Postherpetic Neuralgia.

    We'll reach out to this number within 24 hrs