FibromyalgiaPhase 3NCT00346034

This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia

A Phase 3 study testing Pregabalin in people with Fibromyalgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 51 sites in 12 countries.

Completed

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

Official record

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Trial summary

The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive open-label pregabalin therapy. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Fibromyalgia
What is being tested?: Pregabalin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 357 participants
Where: 51 sitesin 12 countries
Study dates: Dec 2006to Feb 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081100, and must have received pregabalin/placebo under double-blind conditions.

Who cannot join

Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081100 which was determined to be related to the study medication by the investigator or the sponsor.

Trial locations and contacts

51 sites in 12 countries.

Country

City, postcode or hospital

51 sites in 12 countries

Canada12 sites

Pfizer Investigational Site
Bathurst, New Brunswick, E2A 4X7
Pfizer Investigational Site
Drummondville, Quebec, J2B 7T1
Pfizer Investigational Site
Hawkesbury, Ontario, K6A 1A1
Pfizer Investigational Site
Kelowna, British Columbia, V1Y 2H4
Pfizer Investigational Site
Montreal, Quebec, H3T 1E2
Pfizer Investigational Site
Pointe-Claire, Quebec, H9R 3J1
Pfizer Investigational Site
Québec, Quebec, G1V 3M7
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 1Z1
Pfizer Investigational Site
Sherbrooke, Quebec, J1H 5N4
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, A1B 3E1
Pfizer Investigational Site
Toronto, Ontario, M3K 2A7
Pfizer Investigational Site
Winnipeg, Manitoba, R3A 1R9

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France5 sites

Pfizer Investigational Site
Clermont-Ferrand, 63003
Pfizer Investigational Site
Lille, Cedex, 59037
Pfizer Investigational Site
Montpellier, Cedex 5, 34295
Pfizer Investigational Site
Paris, 75181
Pfizer Investigational Site
Saint-Priest-en-Jarez, 42270

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Italy5 sites

Pfizer Investigational Site
Bari, 79124
Pfizer Investigational Site
Benevento, 82100
Pfizer Investigational Site
Bologna, 40138
Pfizer Investigational Site
Chieti Scalo, 66013
Pfizer Investigational Site
Pisa

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United Kingdom5 sites

Pfizer Investigational Site
Greenock, Renfrewshire, PA16 0XN
Pfizer Investigational Site
London, WC1X 8LD
Pfizer Investigational Site
Manchester, Greater Manchester, M6 8HD
Pfizer Investigational Site
North Shields, Tyne and Wear, NE29 8NH
Pfizer Investigational Site
Poole, BH12 2JB

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Germany4 sites

Pfizer Investigational Site
Berlin, 10117
Pfizer Investigational Site
Berlin, 14109
Pfizer Investigational Site
Mannheim, 68161
Pfizer Investigational Site
München, 80336

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India4 sites

Pfizer Investigational Site
Indore, Madhya Pradesh, 452001
Pfizer Investigational Site
Lucknow, Uttar Pradesh, 226 014
Pfizer Investigational Site
Ludhiana, Punjab, 141 001
Pfizer Investigational Site
Ludhiana, Punjab, 141 008

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Netherlands4 sites

Pfizer Investigational Site
Alkmaar, 1815 JD
Pfizer Investigational Site
Den Helder, 1782 GZ
Pfizer Investigational Site
Leeuwarden, 8934 AD
Pfizer Investigational Site
Zwolle, 8011 JW

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Sweden4 sites

Pfizer Investigational Site
Linköping, 581 85
Pfizer Investigational Site
Mölndal, 431 37
Pfizer Investigational Site
Örebro, 701 85
Pfizer Investigational Site
Stockholm, SE-112 81

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South Korea3 sites

Pfizer Investigational Site
Seoul, 133-792
Pfizer Investigational Site
Seoul, 143-914
Pfizer Investigational Site
Suwon, Kyeongki-do, 442-712

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Denmark2 sites

Pfizer Investigational Site
Frederiksberg, 2000
Pfizer Investigational Site
Svendborg, 5700

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Switzerland2 sites

Pfizer Investigational Site
Zurich, 8063
Pfizer Investigational Site
Zurich, 8091

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Portugal1 site

Pfizer Investigational Site
Lisbon, 1700-360

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About this study

Official title: A 12 Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia

Conditions: Fibromyalgia
Being tested: Pregabalin
Medical subject headings: Fibromyalgia

What participants receive

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

PregabalinDrug
150 to 600mg/day

Study groups in NCT00346034
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Pregabalin

What is being measured

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

Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score
Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 "no pain" to 100 "worst possible pain". Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind.
Measured: Week 4
Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score
Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 "no pain" to 100 "worst possible pain". Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind.
Measured: Week 12 (end of treatment)

Timeline

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

Dec 2006Feb 2008

First posted29 Jun 2006 (estimated)
Study startDec 2006
Primary completionFeb 2008
Study completionFeb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
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: 357 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00346034
Sponsor's protocol ID: A0081101
Status last verified: Nov 2018
First submitted: 28 Jun 2006
Last updated: 22 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Arnold LM, Emir B, Murphy TK, Zeiher BG, Pauer L, Scott G, Petersel D. Safety profile and tolerability of up to 1 year of pregabalin treatment in 3 open-label extension studies in patients with fibromyalgia. Clin Ther. 2012 May;34(5):1092-102. doi: 10.1016/j.clinthera.2012.03.003. Epub 2012 Apr 14.
PubMed 22503162

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

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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 12 Week, Open-Label, Safety Trial Of Pregabalin In Patients With Fibromyalgia
ClinicalTrials.gov ID: NCT00346034
Acronym / sponsor ID: A0081101
Conditions: Fibromyalgia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 357 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Dec 2006
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 29 Jun 2006 (estimated)
Results: Posted 13 Mar 2009

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: Pregabalin

Who may qualify

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

Key inclusion criteria (1 listed)

Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081100, and must have received pregabalin/placebo under double-blind conditions.

Key exclusion criteria (1 listed)

Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081100 which was determined to be related to the study medication by the investigator or the sponsor.

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
Pregabalin150 to 600mg/day	Drug	1

Primary outcome

Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score
Time frame: Week 4
Mean Change: Observation VAS score minus Baseline score. Pain VAS: 100 mm horizontal line to rate (score) pain from 0 "no pain" to 100 "worst possible pain". Baseline = value @ double-blind screening if randomized to pregabalin during double-blind or value @ last visit from double-blind if randomized to placebo during double-blind.
Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score
Time frame: Week 12 (end of treatment)
Mean Change: Observation VAS score minus Baseline score. Pain VAS is a 100mm horizontal line used to rate (score) pain by subject from 0 "no pain" to 100 "worst possible pain". Baseline=value @ double-blind screening if randomized to pregabalin during double-blind OR value @ last visit from double-blind if randomized to placebo during double-blind.

Results and safety

Results posted to the registry on 13 Mar 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregabalin	357	300

Primary outcome: Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score

Time frame: Week 4. Mean (Standard Deviation). Unit: mm

Measure	Pregabalin n = 306
Value	-18.1 (24.1)

Population analysed: This will include all patients who have received at least one dose of study medication and had observations at both baseline and week 4.

Primary outcome: Change From Baseline to Week 12 in Pain Visual Analog Scale (VAS) Score

Time frame: Week 12 (end of treatment). Mean (Standard Deviation). Unit: mm

Measure	Pregabalin n = 335
Value	-20.1 (26.8)

Population analysed: This will include all patients who have received at least one dose of study medication and observations at both baseline and week 12.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	6 of ?	173 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22503162Arnold LM, Emir B, Murphy TK, Zeiher BG, Pauer L, Scott G, Petersel D. Safety profile and tolerability of up to 1 year of pregabalin treatment in 3 open-label extension studies in patients with fibromyalgia. Clin Ther. 2012 May;34(5):1092-102. doi: 10.1016/j.clinthera.2012.03.003. Epub 2012 Apr 14.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Fibromyalgia

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
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Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
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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

51 sites in 12 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 Fibromyalgia, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 51 sites in 12 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 1 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 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Canada, France, Italy, United Kingdom, Germany and 7 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?

Yes. Results are posted in the registry (first posted 13 Mar 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline to Week 4 in Pain Visual Analog Scale (VAS) Score (time frame: Week 4). The study lists 2 primary outcomes in all. 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 NCT00346034, 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 22 Jan 2021.