MedDataX Logo

A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin In Patients With Fibromyalgia

NCT ID: NCT00830128

Last Updated: 2021-01-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will assess the safety and efficacy of the long-term use of pregabalin at doses up to 450 mg/day in patients with fibromyalgia who have completed 16 weeks of dosing in Study A0081208 (NCT00830167).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Safety Study Of Pregabalin In Fibromyalgia

NCT00282997

Fibromyalgia
COMPLETED PHASE3

A Study of the Efficacy and Safety of Pregabalin for the Treatment of Fibromyalgia

NCT00645398

Fibromyalgia
COMPLETED PHASE3

An Open-Label Trial of Pregabalin in Patients With Fibromyalgia

NCT00151528

Fibromyalgia
COMPLETED PHASE3

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

NCT00346034

Fibromyalgia
COMPLETED PHASE3

Safety and Efficacy Study of Pregabalin in Fibromyalgia

NCT00151489

Fibromyalgia
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fibromyalgia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

pregabalin (Lyrica)

Group Type EXPERIMENTAL

pregabalin (Lyrica)

Intervention Type DRUG

Dosage: 300-450 mg/day (150-225 mg twice daily), oral administration, Treatment duration: 52 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pregabalin (Lyrica)

Dosage: 300-450 mg/day (150-225 mg twice daily), oral administration, Treatment duration: 52 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Exclusion Criteria

* Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081208; which was determined to be related to the study medication by the investigator or the sponsor.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Yotukaidou, Chiba, Japan

Site Status

Pfizer Investigational Site

Matuyama-si, Ehime, Japan

Site Status

Pfizer Investigational Site

Iiduka, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Kobe, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Mito, Ibaraki, Japan

Site Status

Pfizer Investigational Site

Morioka, Iwate, Japan

Site Status

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Tsu, Mie-ken, Japan

Site Status

Pfizer Investigational Site

Sendai, Miyagi, Japan

Site Status

Pfizer Investigational Site

Hiki-gun, Saitama, Japan

Site Status

Pfizer Investigational Site

Saitama-shi, Saitama, Japan

Site Status

Pfizer Investigational Site

Shimotsuga-gun, Tochigi, Japan

Site Status

Pfizer Investigational Site

Chiyoda-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Itabashi-Ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Shinagawa-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Nagano, , Japan

Site Status

Pfizer Investigational Site

Osaka, , Japan

Site Status

Pfizer Investigational Site

Ōita, , Japan

Site Status

Pfizer Investigational Site

Yokohama, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Related Links

Access external resources that provide additional context or updates about the study.

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081209&StudyName=A%20Long-Term%20Study%20To%20Evaluate%20Safety%20And%20Efficacy%20Of%20Pregabalin%20In%20Patients%20With%20Fibromyalgia

To obtain contact information for a study center near you, click here.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A0081209

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Controlled Pregabalin Trial In Fibromyalgia
NCT00230776 COMPLETED PHASE3
A Study For Pregabalin In Patients With Fibromyalgia
NCT01387607 COMPLETED PHASE3
Pregabalin In Adolescent Patients With Fibromyalgia
NCT01020526 COMPLETED PHASE4
Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia.
NCT00333866 COMPLETED PHASE3
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Postherpetic Neuralgia
NCT00424372 COMPLETED PHASE3
Adolescent Fibromyalgia Study
NCT01020474 COMPLETED PHASE4
A Long-Term Study To Evaluate Safety And Efficacy Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
NCT00553280 COMPLETED PHASE3
An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain
NCT01202227 COMPLETED PHASE3
A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic Pain
NCT00301223 COMPLETED PHASE3
Effects Of Pregabalin (Lyrica) On Sleep Maintenance In Subjects With Fibromyalgia
NCT00883740 COMPLETED PHASE3
Special Investigation of Pregabalin for Fibromyalgia (Regulatory Post Marketing Commitment Plan)
NCT01773993 COMPLETED
A Post Marketing Surveillance Study On Pregabalin (Lyrica) On Efficacy, Safety And Tolerability Of Pregabalin
NCT00892008 COMPLETED
A 13-Week, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Postherpetic Neuralgia
NCT00394901 COMPLETED PHASE3
PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin
NCT02273908 COMPLETED
Safety And Efficacy In Long Term Use Of Lyrica (Regulatory Post Marketing Commitment Plan)
NCT01279850 COMPLETED
Primary Care Identification Of Patients With Chronic Neuropathic Low Back Pain Study
NCT01298466 WITHDRAWN PHASE4
Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)
NCT01455428 COMPLETED PHASE4
The Efficacy and Safety of Pregabalin Release Tablets for the Treatment of Fibromyalgia
NCT02868814 UNKNOWN PHASE3
Efficacy of Pregabalin Versus Combined Pregabalin and Milnacipran in Fibromyalgia.
NCT03905486 COMPLETED NA
Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
NCT00553475 COMPLETED PHASE3
Evaluate Long-Term Safety and Efficacy of Pregabalin in Patients With Chronic Neuropathic Pain.
NCT00141362 COMPLETED PHASE3
Symptomatic Treatment Of Patients With Neuropathic Pain With LYRICA
NCT00843284 COMPLETED
Trial of Efficacy and Safety of Pregabalin in Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy
NCT00159705 COMPLETED PHASE3
Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia
NCT01603394 TERMINATED PHASE4
To Evaluate Long-Term Safety and Efficacy of Pregabalin in the Treatment of Neuropathic Pain After Spinal Cord Injury.
NCT00141375 COMPLETED PHASE3