NCT00141375

Brief Summary

To evaluate long-term safety and efficacy of pregabalin in the treatment of neuropathic pain after spinal cord injury.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2002

Typical duration for phase_3

Geographic Reach
1 country

7 active sites

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

Study Start

First participant enrolled

August 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

January 15, 2008

Status Verified

January 1, 2008

First QC Date

August 30, 2005

Last Update Submit

January 9, 2008

Conditions

Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

  • Safety and Efficacy

Interventions

PregabalinDRUG

Eligibility Criteria

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

You may qualify if:

  • Must have received study medication under double-blind conditions.

You may not qualify if:

  • Patients cannot participate if they experienced a serious adverse event during the previous double-blind BID study which was determined to be related to the study medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Pfizer Investigational Site

Little Bay, New South Wales, 2036, Australia

Location

Pfizer Investigational Site

St Leonards, New South Wales, 2065, Australia

Location

Pfizer Investigational Site

Warrawong, New South Wales, 2502, Australia

Location

Pfizer Investigational Site

Woolloongabba, Queensland, 4102, Australia

Location

Pfizer Investigational Site

Heidelberg, Victoria, 3084, Australia

Location

Pfizer Investigational Site

Shenton Park, Western Australia, 6008, Australia

Location

Pfizer Investigational Site

NSW, Australia

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2005

First Posted

September 1, 2005

Study Start

August 1, 2002

Study Completion

January 1, 2006

Last Updated

January 15, 2008

Record last verified: 2008-01

Locations

AU(7)