Determine Long-Term Safety and Tolerability of Pregabalin in Patients With Anxiety Disorders.

July 13, 2006 updated by: Pfizer

A 1-Year Open-Label Safety Extension Study of Pregabalin in Patients With Anxiety Disorders

Determine long-term safety and tolerability of pregabalin in patients with anxiety disorders.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

511

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

        • Pfizer Investigational Site
  • Austria
      • A-1040 Wien, Austria
        • Pfizer Investigational Site
      • Wein, Austria, A-1020
        • Pfizer Investigational Site
      • Wien, Austria, A-1050
        • Pfizer Investigational Site
  • Belgium
      • Brussels, Belgium, 1020
        • Pfizer Investigational Site
      • De Pinte, Belgium, 9840
        • Pfizer Investigational Site
      • Gent, Belgium, 9000
        • Pfizer Investigational Site
      • Kortrijk, Belgium, 8500
        • Pfizer Investigational Site
      • Lede, Belgium, 9340
        • Pfizer Investigational Site
      • Liege, Belgium, B-4000
        • Pfizer Investigational Site
      • Sint-Denijs-Westrem, Belgium, 9051
        • Pfizer Investigational Site
      • Tielt, Belgium, 8700
        • Pfizer Investigational Site
      • Tournai, Belgium, 7500
        • Pfizer Investigational Site
  • Estonia
      • Tallinn, Estonia, 10614
        • Pfizer Investigational Site
      • Tartu, Estonia, 50417
        • Pfizer Investigational Site
  • France
      • Denguin, France, 64230
        • Pfizer Investigational Site
      • Elancourt, France, 78990
        • Pfizer Investigational Site
      • Metz, France, F-57000
        • Pfizer Investigational Site
      • Montesson, France, 78360
        • Pfizer Investigational Site
      • Montigny les Metz, France, 57950
        • Pfizer Investigational Site
      • Saint Etienne du Gres, France, 13103
        • Pfizer Investigational Site
      • Wasquehal, France, 59290
        • Pfizer Investigational Site
    • Cedex
      • Reims, Cedex, France, 51092
        • Pfizer Investigational Site
  • Germany
      • Bad-Deurrheim, Germany, 78073
        • Pfizer Investigational Site
      • Bremerhaven, Germany, 27568
        • Pfizer Investigational Site
      • Gottingen, Germany, D-37073
        • Pfizer Investigational Site
      • Gottingen, Germany, D-37085
        • Pfizer Investigational Site
      • Hamburg, Germany, D-22767
        • Pfizer Investigational Site
      • Kothen, Germany, D-06366
        • Pfizer Investigational Site
      • Lauf, Germany, 77886
        • Pfizer Investigational Site
      • Oldenburg, Germany, 26121
        • Pfizer Investigational Site
      • Osnabrueck, Germany, 49078
        • Pfizer Investigational Site
      • Siegen, Germany, 57072
        • Pfizer Investigational Site
      • Spaichingen, Germany, 78549
        • Pfizer Investigational Site
  • Israel
      • Ness Ziona, Israel, 70450
        • Pfizer Investigational Site
  • Italy
      • Bassano del Grappa (Vicenza), Italy, 36061
        • Pfizer Investigational Site
      • Bologna, Italy, 40123
        • Pfizer Investigational Site
      • Milano, Italy
        • Pfizer Investigational Site
      • Roma, Italy, 00122
        • Pfizer Investigational Site
  • Latvia
      • Riga, Latvia
        • Pfizer Investigational Site
  • Netherlands
      • Ambacht, Netherlands, 3341 CS HI
        • Pfizer Investigational Site
      • BV Losser, Netherlands, 7581
        • Pfizer Investigational Site
      • GC Nijmegen, Netherlands, 6525
        • Pfizer Investigational Site
      • Hoogvliet, Netherlands, 3192 JN
        • Pfizer Investigational Site
      • Huizen, Netherlands, 1271 BB
        • Pfizer Investigational Site
      • Losser, Netherlands, 7581 BV
        • Pfizer Investigational Site
      • RC Dordrecht, Netherlands, 3317
        • Pfizer Investigational Site
      • Zwigndrecht, Netherlands, 3333 EP
        • Pfizer Investigational Site
      • Zwijndreacht, Netherlands, 3334 XA
        • Pfizer Investigational Site
      • Zwijndrecht, Netherlands, 3331 AE
        • Pfizer Investigational Site
      • Zwijndrecht, Netherlands, 3332 AJ
        • Pfizer Investigational Site
      • Zwijndrecht, Netherlands, 3335 EJ
        • Pfizer Investigational Site
  • Poland
      • Bialystok, Poland, 15-420
        • Pfizer Investigational Site
      • Bydgoszcz, Poland, 85-096
        • Pfizer Investigational Site
      • Katowice, Poland, 40-635
        • Pfizer Investigational Site
      • Olsztyn, Poland, 10-511
        • Pfizer Investigational Site
      • Torun, Poland, 87-100
        • Pfizer Investigational Site
      • Tuszyn, Poland, 95-080
        • Pfizer Investigational Site
      • Warszawa, Poland, 02-957
        • Pfizer Investigational Site
      • Wroclaw, Poland, 50-229
        • Pfizer Investigational Site
      • Zabrze, Poland, 41-800
        • Pfizer Investigational Site
  • South Africa
      • Bellville, South Africa, 7530
        • Pfizer Investigational Site
      • Bloemfontein, South Africa, 9301
        • Pfizer Investigational Site
      • Bloemfontein, South Africa, 9330
        • Pfizer Investigational Site
      • East London, South Africa, 5201
        • Pfizer Investigational Site
      • George, South Africa, 6529
        • Pfizer Investigational Site
      • Hurlingham, Johannesburg, South Africa, 2070
        • Pfizer Investigational Site
      • Pietersburg, South Africa, 0699
        • Pfizer Investigational Site
      • Pinetown Natal, South Africa, 3610
        • Pfizer Investigational Site
      • Pretoria, South Africa, 0002
        • Pfizer Investigational Site
      • Pretoria, South Africa, 0181
        • Pfizer Investigational Site
      • Sandton, South Africa, 2196
        • Pfizer Investigational Site
      • Somerset West, South Africa, 7130
        • Pfizer Investigational Site
      • Westville, South Africa, 3630
        • Pfizer Investigational Site
    • Cape Town
      • Goodwood, Cape Town, South Africa, 7460
        • Pfizer Investigational Site
      • Paarl, Cape Town, South Africa, 7646
        • Pfizer Investigational Site
    • Johannesburg
      • Kempton Park, Johannesburg, South Africa, 1619
        • Pfizer Investigational Site
      • Rosebank, Johannesburg, South Africa, 2196
        • Pfizer Investigational Site
    • Pretoria
      • Hatfield, Pretoria, South Africa, 0083
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
      • Barcelona, Spain, 08100
        • Pfizer Investigational Site
      • Madrid, Spain, 28006
        • Pfizer Investigational Site
      • Madrid, Spain, 28041
        • Pfizer Investigational Site
      • Madrid, Spain, 28009
        • Pfizer Investigational Site
      • Madrid, Spain, 28037
        • Pfizer Investigational Site
      • Pamplona, Spain, 31014
        • Pfizer Investigational Site
      • Sevilla, Spain, 41700
        • Pfizer Investigational Site
      • Zaragoza, Spain, 50007
        • Pfizer Investigational Site
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Pfizer Investigational Site
    • Barcelona
      • Granollers, Barcelona, Spain, 08400
        • Pfizer Investigational Site
  • Ukraine
      • Kharkov, Ukraine, 61068
        • Pfizer Investigational Site
      • Lviv, Ukraine, 79021
        • Pfizer Investigational Site
      • Odessa, Ukraine, 65006
        • Pfizer Investigational Site
  • United Kingdom
      • Birmingham, United Kingdom, B37 7TR
        • Pfizer Investigational Site
      • Bolton, United Kingdom, BL4 9QZ
        • Pfizer Investigational Site
      • Bolton, United Kingdom, BL6 7AN
        • Pfizer Investigational Site
      • Chesterfield, United Kingdom, S40 1LE
        • Pfizer Investigational Site
      • Cookstown, United Kingdom, BT80 8BN
        • Pfizer Investigational Site
      • Coventry, United Kingdom, CV12 OHU
        • Pfizer Investigational Site
      • Coventry, United Kingdom, CV2 1SG
        • Pfizer Investigational Site
      • Coventry, United Kingdom, CV6 4DD
        • Pfizer Investigational Site
      • Coventry, United Kingdom, CV7 8LA
        • Pfizer Investigational Site
      • Dundee, United Kingdom, DD1 5LA
        • Pfizer Investigational Site
      • Earlsdon, Coventry, United Kingdom, CV5 6EU
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G3 8YJ
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G41 3YE
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G69 7AD
        • Pfizer Investigational Site
      • Leeds, United Kingdom, LS12 ITZ
        • Pfizer Investigational Site
      • London, United Kingdom, SE13 6LH
        • Pfizer Investigational Site
      • Port Glasgow, United Kingdom, PA14 6HW
        • Pfizer Investigational Site
      • Rugby, United Kingdom, CV21 3SP
        • Pfizer Investigational Site
    • Berks
      • Slough, Berks, United Kingdom, SL2 1HD
        • Pfizer Investigational Site
    • Berkshire
      • Maidenhead, Berkshire, United Kingdom, SL6 2LH
        • Pfizer Investigational Site
    • Cornwall
      • Falmouth, Cornwall, United Kingdom, TR11 2LH
        • Pfizer Investigational Site
      • Fowey, Cornwall, United Kingdom, PL23 1DT
        • Pfizer Investigational Site
      • Penzance, Cornwall, United Kingdom, TR18 4JH
        • Pfizer Investigational Site
      • Saltash, Cornwall, United Kingdom, PL12 6DL
        • Pfizer Investigational Site
      • St. Austell, Cornwall, United Kingdom, PL26 7RL
        • Pfizer Investigational Site
    • County Down
      • Downpatrick, County Down, United Kingdom, BT30 6HY
        • Pfizer Investigational Site
    • Derbyshire
      • Chesterfield, Derbyshire, United Kingdom, S40 4TF
        • Pfizer Investigational Site
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 7TH
        • Pfizer Investigational Site
    • East Sussex
      • Bexhill on Sea, East Sussex, United Kingdom, TN40 1JJ
        • Pfizer Investigational Site
      • Bexhill-on-sea, East Sussex, United Kingdom, TN40 1HE
        • Pfizer Investigational Site
    • Essex
      • Leigh-On-Sea, Essex, United Kingdom, SS3 2SQ
        • Pfizer Investigational Site
    • Fife
      • Leslie, Fife, United Kingdom, KY6 3LQ
        • Pfizer Investigational Site
      • Limekilns, Fife, United Kingdom, KY11 3HS
        • Pfizer Investigational Site
    • Glasgow
      • Cathcart, Glasgow, United Kingdom, G44 3DH
        • Pfizer Investigational Site
      • Clarckston, Glasgow, United Kingdom, G76 7BX
        • Pfizer Investigational Site
      • Rutherglen, Glasgow, United Kingdom, G73 2PQ
        • Pfizer Investigational Site
    • Lancashire
      • Bolton, Lancashire, United Kingdom, BL1 6AF
        • Pfizer Investigational Site
    • London
      • Chelsea, London, United Kingdom, SW3 4BP
        • Pfizer Investigational Site
    • Northern Ireland
      • Bangor, Northern Ireland, United Kingdom, BT19 1PP
        • Pfizer Investigational Site
      • Greenisland, Carrickfergus, Northern Ireland, United Kingdom, BT38 8TP
        • Pfizer Investigational Site
    • Renfrewshire
      • Houston, Renfrewshire, United Kingdom, PA6 7AR
        • Pfizer Investigational Site
    • South Yorkshire
      • Epworth, Doncaster, South Yorkshire, United Kingdom, DN9 1EP
        • Pfizer Investigational Site
    • Surrey
      • St. John's, Woking, Surrey, United Kingdom, GU21 ITD
        • Pfizer Investigational Site
    • Wiltshire
      • Trowbridge, Wiltshire, United Kingdom, BA14 8QA
        • Pfizer Investigational Site
    • Worcestershire
      • Inkberrow, Worcestershire, United Kingdom, WR7 4ED
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have completed the double-blind portion of the preceding trial
  • Completed any protocol specified withdrawal phase and follow-up visits.

Exclusion Criteria:

  • Patient cannot participate if they experienced a serious adverse event or a nonserious, but medically significant adverse event during the preceding efficacy study that was judged to be related to the study medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety Tolerability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 8, 2005

Study Record Updates

Last Update Posted (Estimate)

July 14, 2006

Last Update Submitted That Met QC Criteria

July 13, 2006

Last Verified

July 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1008-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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