Trial of Efficacy and Safety of Pregabalin in Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy

NCT ID: NCT00159705

Last Updated: 2021-01-25

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

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-06-30

Brief Summary

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Trial will evaluate the efficacy and safety of pregabalin in the treatment of subjects with neuropathic pain associated with lumbo-sacral radiculopathy.

Detailed Description

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Conditions

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Radiculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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pregabalin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pain consistent with a diagnosis of chronic lumbo-sacral radiculopathy due to spinal stenosis or disk herniation.
* Radicular pain must be present for at least 3 months and pain stable for at least 4 weeks.

Exclusion Criteria

* Surgery for lumbo-sacral radiculopathy within previous 6 months and/or more than one previous spinal surgery for pain-radiculopathy.
* Epidural injection for lumbo-sacral radiculopathy within previous 6 weeks and/or anticipated need for treatment with opioid analgesics, anti-epileptic medications or tricyclic antidepressants to alleviate pain due to lumbo-sacral radiculopathy during the course of the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Phoenix, Arizona, United States

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Denver, Colorado, United States

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Plantation, Florida, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Boston, Massachusetts, United States

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Independence, Missouri, United States

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Rochester, New York, United States

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Valley Stream, New York, United States

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Portland, Oregon, United States

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Allentown, Pennsylvania, United States

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Allentown, Pennsylvania, United States

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Bethlehem, Pennsylvania, United States

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Edegem, , Belgium

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Eeklo, , Belgium

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Genk, , Belgium

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Pellenberg, , Belgium

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Vancouver, British Columbia, Canada

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Hawkesbury, Ontario, Canada

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Kingston, Ontario, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Fleurimont, Quebec, Canada

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Montreal, Quebec, Canada

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Bremen, , Germany

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Eichstätt, , Germany

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Göppingen, , Germany

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Kiel, , Germany

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München, , Germany

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Nuremberg, , Germany

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Wiesbaden, , Germany

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Localita' Cravino, Pavia, Italy

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Imperia, , Italy

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Milan, , Italy

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Napoli, , Italy

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Pavia, , Italy

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Roma, , Italy

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Badalona, Barcelona, Spain

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Granada, , Spain

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Madrid, , Spain

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Seville, , Spain

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Seville, , Spain

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Valencia, , Spain

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Gothenburg, , Sweden

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Lidingö, , Sweden

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Linköping, , Sweden

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Luleå, , Sweden

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Skellefteå, , Sweden

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Stockholm, , Sweden

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Inciraltı, İzmir, Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Countries

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United States Belgium Canada Germany Italy Spain Sweden Turkey (Türkiye)

Related Links

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Other Identifiers

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A0081007

Identifier Type: -

Identifier Source: org_study_id

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