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

NCT ID: NCT00150449

Last Updated: 2006-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

511 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2006-03-31

Brief Summary

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

Detailed Description

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Conditions

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Anxiety Neuroses

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pregabalin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Bangor, Northern Ireland, United Kingdom

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Greenisland, Carrickfergus, Northern Ireland, United Kingdom

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Houston, Renfrewshire, United Kingdom

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A-1040 Wien, , Austria

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Vienna, , Austria

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Wein, , Austria

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Brussels, , Belgium

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De Pinte, , Belgium

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Ghent, , Belgium

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Kortrijk, , Belgium

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Lede, , Belgium

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Liège, , Belgium

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Sint-Denijs-Westrem, , Belgium

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Tielt, , Belgium

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Tournai, , Belgium

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Tallinn, , Estonia

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Tartu, , Estonia

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Reims, Cedex, France

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Denguin, , France

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Élancourt, , France

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Metz, , France

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Montesson, , France

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Montigny-lès-Metz, , France

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Saint-Étienne-du-Grès, , France

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Wasquehal, , France

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Bad-Deurrheim, , Germany

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Bremerhaven, , Germany

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Göttingen, , Germany

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Göttingen, , Germany

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Hamburg, , Germany

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Köthen, , Germany

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Lauf, , Germany

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Oldenburg, , Germany

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Osnabrück, , Germany

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Siegen, , Germany

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Spaichingen, , Germany

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Ness Ziona, , Israel

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Bassano Del Grappa (Vicenza), , Italy

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Bologna, , Italy

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Milan, , Italy

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Roma, , Italy

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Riga, , Latvia

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BV Losser, , Netherlands

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GC Nijmegen, , Netherlands

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Hoogvliet, , Netherlands

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Huizen, , Netherlands

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Losser, , Netherlands

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RC Dordrecht, , Netherlands

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Vlaardinger-Ambacht, , Netherlands

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Zwigndrecht, , Netherlands

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Zwijndreacht, , Netherlands

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Zwijndrecht, , Netherlands

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Zwijndrecht, , Netherlands

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Zwijndrecht, , Netherlands

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Bialystok, , Poland

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Bydgoszcz, , Poland

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Katowice, , Poland

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Olsztyn, , Poland

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Torun, , Poland

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Tuszyn, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Zabrze, , Poland

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Goodwood, Cape Town, South Africa

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Paarl, Cape Town, South Africa

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Kempton Park, Johannesburg, South Africa

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Rosebank, Johannesburg, South Africa

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Hatfield, Pretoria, South Africa

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Bellville, , South Africa

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Bloemfontein, , South Africa

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Bloemfontein, , South Africa

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East London, , South Africa

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George, , South Africa

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Hurlingham, Johannesburg, , South Africa

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Pinetown Natal, , South Africa

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Polokwane, , South Africa

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Pretoria, , South Africa

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Pretoria, , South Africa

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Sandton, , South Africa

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Somerset West, , South Africa

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Westville, , South Africa

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Granollers, Barcelona, Spain

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Oviedo, Principality of Asturias, Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Pamplona, , Spain

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Seville, , Spain

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Zaragoza, , Spain

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Kharkiv, , Ukraine

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Lviv, , Ukraine

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Odesa, , Ukraine

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Maidenhead, Berkshire, United Kingdom

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Slough, Berks, United Kingdom

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Falmouth, Cornwall, United Kingdom

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Fowey, Cornwall, United Kingdom

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Penzance, CORNWALL, United Kingdom

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Saltash, Cornwall, United Kingdom

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St Austell, CORNWALL, United Kingdom

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Downpatrick, County Down, United Kingdom

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Chesterfield, Derbyshire, United Kingdom

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Plymouth, Devon, United Kingdom

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Bexhill-on-Sea, EAST SUSSEX, United Kingdom

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Bexhill-on-Sea, East Sussex, United Kingdom

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Leigh-on-Sea, Essex, United Kingdom

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Leslie, Fife, United Kingdom

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Limekilns, Fife, United Kingdom

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Cathcart, Glasgow, United Kingdom

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Clarckston, Glasgow, United Kingdom

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Rutherglen, Glasgow, United Kingdom

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Bolton, Lancashire, United Kingdom

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Chelsea, London, United Kingdom

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Epworth, Doncaster, South Yorkshire, United Kingdom

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Saint John's, Woking, Surrey, United Kingdom

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Trowbridge, WILTSHIRE, United Kingdom

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Inkberrow, Worcestershire, United Kingdom

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Birmingham, , United Kingdom

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Bolton, , United Kingdom

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Bolton, , United Kingdom

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Chesterfield, , United Kingdom

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Cookstown, , United Kingdom

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Coventry, , United Kingdom

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Coventry, , United Kingdom

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Coventry, , United Kingdom

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Coventry, , United Kingdom

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Dundee, , United Kingdom

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Earlsdon, Coventry, , United Kingdom

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Glasgow, , United Kingdom

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Glasgow, , United Kingdom

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Glasgow, , United Kingdom

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Leeds, , United Kingdom

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London, , United Kingdom

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Port Glasgow, , United Kingdom

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Rugby, , United Kingdom

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Countries

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Austria Belgium Estonia France Germany Israel Italy Latvia Netherlands Poland South Africa Spain Ukraine United Kingdom

References

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Montgomery S, Emir B, Haswell H, Prieto R. Long-term treatment of anxiety disorders with pregabalin: a 1 year open-label study of safety and tolerability. Curr Med Res Opin. 2013 Oct;29(10):1223-30. doi: 10.1185/03007995.2013.820694. Epub 2013 Aug 19.

Reference Type DERIVED
PMID: 23808960 (View on PubMed)

Related Links

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Other Identifiers

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1008-100

Identifier Type: -

Identifier Source: org_study_id