Anxiety NeurosesPhase 3NCT00150449

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

A Phase 3 study testing Pregabalin in people with Anxiety Neuroses, run by Pfizer at 138 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Determine long-term safety and tolerability of pregabalin in patients with anxiety disorders. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Anxiety Neuroses
What is being tested?: Pregabalin
How many people: 511 participants
Where: 138 sitesin 15 countries
Study dates: Jan 2001to Mar 2006
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

138 sites in 15 countries.

Country

City, postcode or hospital

138 sites in 15 countries

United Kingdom45 sites

Pfizer Investigational Site
Bangor, Northern Ireland, BT19 1PP
Pfizer Investigational Site
Bexhill-on-Sea, EAST SUSSEX, TN40 1HE
Pfizer Investigational Site
Bexhill-on-Sea, East Sussex, TN40 1JJ
Pfizer Investigational Site
Birmingham, B37 7TR
Pfizer Investigational Site
Bolton, Lancashire, BL1 6AF
Pfizer Investigational Site
Bolton, BL4 9QZ
Pfizer Investigational Site
Bolton, BL6 7AN
Pfizer Investigational Site
Cathcart, Glasgow, G44 3DH
Pfizer Investigational Site
Chelsea, London, SW3 4BP
Pfizer Investigational Site
Chesterfield, Derbyshire, S40 4TF
Pfizer Investigational Site
Chesterfield, S40 1LE
Pfizer Investigational Site
Clarckston, Glasgow, G76 7BX
Pfizer Investigational Site
Cookstown, BT80 8BN
Pfizer Investigational Site
Coventry, CV12 OHU
Pfizer Investigational Site
Coventry, CV2 1SG
Pfizer Investigational Site
Coventry, CV6 4DD
Pfizer Investigational Site
Coventry, CV7 8LA
Pfizer Investigational Site
Downpatrick, County Down, BT30 6HY
Pfizer Investigational Site
Dundee, DD1 5LA
Pfizer Investigational Site
Earlsdon, Coventry, CV5 6EU
Pfizer Investigational Site
Epworth, Doncaster, South Yorkshire, DN9 1EP
Pfizer Investigational Site
Falmouth, Cornwall, TR11 2LH
Pfizer Investigational Site
Fowey, Cornwall, PL23 1DT
Pfizer Investigational Site
Glasgow, G3 8YJ
Pfizer Investigational Site
Glasgow, G41 3YE
Pfizer Investigational Site
Glasgow, G69 7AD
Pfizer Investigational Site
Greenisland, Carrickfergus, Northern Ireland, BT38 8TP
Pfizer Investigational Site
Houston, Renfrewshire, PA6 7AR
Pfizer Investigational Site
Inkberrow, Worcestershire, WR7 4ED
Pfizer Investigational Site
Leeds, LS12 ITZ
Pfizer Investigational Site
Leigh-on-Sea, Essex, SS3 2SQ
Pfizer Investigational Site
Leslie, Fife, KY6 3LQ
Pfizer Investigational Site
Limekilns, Fife, KY11 3HS
Pfizer Investigational Site
London, SE13 6LH
Pfizer Investigational Site
Maidenhead, Berkshire, SL6 2LH
Pfizer Investigational Site
Penzance, CORNWALL, TR18 4JH
Pfizer Investigational Site
Plymouth, Devon, PL6 7TH
Pfizer Investigational Site
Port Glasgow, PA14 6HW
Pfizer Investigational Site
Rugby, CV21 3SP
Pfizer Investigational Site
Rutherglen, Glasgow, G73 2PQ
Pfizer Investigational Site
Saint John's, Woking, Surrey, GU21 ITD
Pfizer Investigational Site
Saltash, Cornwall, PL12 6DL
Pfizer Investigational Site
Slough, Berks, SL2 1HD
Pfizer Investigational Site
St Austell, CORNWALL, PL26 7RL
Pfizer Investigational Site
Trowbridge, WILTSHIRE, BA14 8QA

Other trials in United Kingdom

South Africa18 sites

Pfizer Investigational Site
Bellville, 7530
Pfizer Investigational Site
Bloemfontein, 9301
Pfizer Investigational Site
Bloemfontein, 9330
Pfizer Investigational Site
East London, 5201
Pfizer Investigational Site
George, 6529
Pfizer Investigational Site
Goodwood, Cape Town, 7460
Pfizer Investigational Site
Hatfield, Pretoria, 0083
Pfizer Investigational Site
Hurlingham, Johannesburg, 2070
Pfizer Investigational Site
Kempton Park, Johannesburg, 1619
Pfizer Investigational Site
Paarl, Cape Town, 7646
Pfizer Investigational Site
Pinetown Natal, 3610
Pfizer Investigational Site
Polokwane, 0699
Pfizer Investigational Site
Pretoria, 0002
Pfizer Investigational Site
Pretoria, 0181
Pfizer Investigational Site
Rosebank, Johannesburg, 2196
Pfizer Investigational Site
Sandton, 2196
Pfizer Investigational Site
Somerset West, 7130
Pfizer Investigational Site
Westville, 3630

Other trials in South Africa

Netherlands12 sites

Pfizer Investigational Site
BV Losser, 7581
Pfizer Investigational Site
GC Nijmegen, 6525
Pfizer Investigational Site
Hoogvliet, 3192 JN
Pfizer Investigational Site
Huizen, 1271 BB
Pfizer Investigational Site
Losser, 7581 BV
Pfizer Investigational Site
RC Dordrecht, 3317
Pfizer Investigational Site
Vlaardinger-Ambacht, 3341 CS HI
Pfizer Investigational Site
Zwigndrecht, 3333 EP
Pfizer Investigational Site
Zwijndreacht, 3334 XA
Pfizer Investigational Site
Zwijndrecht, 3331 AE
Pfizer Investigational Site
Zwijndrecht, 3332 AJ
Pfizer Investigational Site
Zwijndrecht, 3335 EJ

Other trials in Netherlands

Germany11 sites

Pfizer Investigational Site
Bad-Deurrheim, 78073
Pfizer Investigational Site
Bremerhaven, 27568
Pfizer Investigational Site
Göttingen, D-37073
Pfizer Investigational Site
Göttingen, D-37085
Pfizer Investigational Site
Hamburg, D-22767
Pfizer Investigational Site
Köthen, D-06366
Pfizer Investigational Site
Lauf, 77886
Pfizer Investigational Site
Oldenburg, 26121
Pfizer Investigational Site
Osnabrück, 49078
Pfizer Investigational Site
Siegen, 57072
Pfizer Investigational Site
Spaichingen, 78549

Other trials in Germany

Spain11 sites

Pfizer Investigational Site
Barcelona, 08036
Pfizer Investigational Site
Barcelona, 08100
Pfizer Investigational Site
Granollers, Barcelona, 08400
Pfizer Investigational Site
Madrid, 28006
Pfizer Investigational Site
Madrid, 28009
Pfizer Investigational Site
Madrid, 28037
Pfizer Investigational Site
Madrid, 28041
Pfizer Investigational Site
Oviedo, Principality of Asturias, 33011
Pfizer Investigational Site
Pamplona, 31014
Pfizer Investigational Site
Seville, 41700
Pfizer Investigational Site
Zaragoza, 50007

Other trials in Spain

Belgium9 sites

Pfizer Investigational Site
Brussels, 1020
Pfizer Investigational Site
De Pinte, 9840
Pfizer Investigational Site
Ghent, 9000
Pfizer Investigational Site
Kortrijk, 8500
Pfizer Investigational Site
Lede, 9340
Pfizer Investigational Site
Liège, B-4000
Pfizer Investigational Site
Sint-Denijs-Westrem, 9051
Pfizer Investigational Site
Tielt, 8700
Pfizer Investigational Site
Tournai, 7500

Other trials in Belgium

Poland9 sites

Pfizer Investigational Site
Bialystok, 15-420
Pfizer Investigational Site
Bydgoszcz, 85-096
Pfizer Investigational Site
Katowice, 40-635
Pfizer Investigational Site
Olsztyn, 10-511
Pfizer Investigational Site
Torun, 87-100
Pfizer Investigational Site
Tuszyn, 95-080
Pfizer Investigational Site
Warsaw, 02-957
Pfizer Investigational Site
Wroclaw, 50-229
Pfizer Investigational Site
Zabrze, 41-800

Other trials in Poland

France8 sites

Pfizer Investigational Site
Denguin, 64230
Pfizer Investigational Site
Élancourt, 78990
Pfizer Investigational Site
Metz, F-57000
Pfizer Investigational Site
Montesson, 78360
Pfizer Investigational Site
Montigny-lès-Metz, 57950
Pfizer Investigational Site
Reims, Cedex, 51092
Pfizer Investigational Site
Saint-Étienne-du-Grès, 13103
Pfizer Investigational Site
Wasquehal, 59290

Other trials in France

Italy4 sites

Pfizer Investigational Site
Bassano Del Grappa (Vicenza), 36061
Pfizer Investigational Site
Bologna, 40123
Pfizer Investigational Site
Milan
Pfizer Investigational Site
Roma, 00122

Other trials in Italy

Austria3 sites

Pfizer Investigational Site
A-1040 Wien
Pfizer Investigational Site
Vienna, A-1050
Pfizer Investigational Site
Wein, A-1020

Other trials in Austria

Ukraine3 sites

Pfizer Investigational Site
Kharkiv, 61068
Pfizer Investigational Site
Lviv, 79021
Pfizer Investigational Site
Odesa, 65006

Other trials in Ukraine

Estonia2 sites

Pfizer Investigational Site
Tallinn, 10614
Pfizer Investigational Site
Tartu, 50417

Other trials in Estonia

Israel1 site

Pfizer Investigational Site
Ness Ziona, 70450

Other trials in Israel

Latvia1 site

Pfizer Investigational Site
Riga

Other trials in Latvia

Location not given1 site

Pfizer Investigational Site

About this study

Official title: 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.

Conditions: Anxiety Neuroses
Being tested: Pregabalin
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PregabalinDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety Tolerability

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2001Mar 2006

First posted8 Sep 2005 (estimated)
Study startJan 2001
Study completionMar 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Anxiety NeurosesStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 511 participants

IDs, dates and publications

ClinicalTrials.gov ID: NCT00150449
Sponsor's protocol ID: 1008-100
Status last verified: Jul 2006
First submitted: 6 Sep 2005
Last updated: 14 Jul 2006
Results posted: No

Publications

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.
PubMed 23808960

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Digital Interventions for Relapse Prevention in Adolescence
Major Depression Disorder, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
Not yet recruiting
The Effect of Skin-to-Skin Contact on Pain and Anxiety During Episiotomy Repair
Episiotomy, Pain
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Not yet recruiting
Virtual Reality for Anxiety and Birth Satisfaction During Elective Cesarean Section
Anxiety, Cesarean Section
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

All Anxiety Neuroses trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 1-Year Open-Label Safety Extension Study of Pregabalin in Patients With Anxiety Disorders
ClinicalTrials.gov ID: NCT00150449
Acronym / sponsor ID: 1008-100
Conditions: Anxiety Neuroses
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 511 participants
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jan 2001
Study completion: Mar 2006
First posted: 8 Sep 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pregabalin	Drug	–

Primary outcome

Safety Tolerability

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2006.
Derived from this study: PubMed 23808960Montgomery 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.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Anxiety Neuroses

Recruiting
Digital Interventions for Relapse Prevention in Adolescence
Major Depression Disorder, ANXIETY DISORDERS (or Anxiety and Phobic Neuroses)
Not yet recruiting
The Effect of Skin-to-Skin Contact on Pain and Anxiety During Episiotomy Repair
Episiotomy, Pain
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Not yet recruiting
Virtual Reality for Anxiety and Birth Satisfaction During Elective Cesarean Section
Anxiety, Cesarean Section
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

138 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pregabalin in people with Anxiety Neuroses, run by Pfizer at 138 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United Kingdom, South Africa, Netherlands, Germany, Spain and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Tolerability. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00150449, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2006.