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A Study To Evaluate Pregabalin In The Treatment Of Moderate To Severe Chronic Bone Pain Related To Metastatic Cancer

NCT ID: NCT00381095

Last Updated: 2021-01-20

Study Results

Results available

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

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2010-10-31

Brief Summary

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The purpose of this study is to assess the analgesic efficacy of flexibly-dosed pregabalin in the adjunctive treatment of subjects with cancer-induced bone pain.

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Detailed Description

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Pfizer decided to discontinue additional enrollment into the study effective Sept 5 2010 after assessing the feasibility of completing this study in a realistic timeframe.The study was not stopped for any safety concerns.

Conditions

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Bone Neoplasms Pain, Intractable Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

flexible dosing

Group Type EXPERIMENTAL

Pregabalin

Intervention Type DRUG

Capsule, Flexible-dosing, Double-blind. Treatment duration is 28 days at 100-600 mg/day administered BID+ taper (6 days).

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Pregabalin

Capsule, Flexible-dosing, Double-blind. Treatment duration is 28 days at 100-600 mg/day administered BID+ taper (6 days).

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient must have a malignant, solid tumor that has been diagnosed as having metastasized to bone, and must have moderate to severe pain secondary to the bone metastasis at an identifiable reference site.

Exclusion Criteria

* The patient who has undergone diagnostic or therapeutic invasive interventions (angiography, biopsy, surgery) less than 15 days prior to study start that would impact their assessment of pain at the reference pain site or area, in the opinion of the investigator.
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

Celebration, Florida, United States

Site Status

Pfizer Investigational Site

Kissimmee, Florida, United States

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Pfizer Investigational Site

Pensacola, Florida, United States

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Pfizer Investigational Site

Pensacola, Florida, United States

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Pfizer Investigational Site

Louisville, Kentucky, United States

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Pfizer Investigational Site

Edina, Minnesota, United States

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Pfizer Investigational Site

Canton, Ohio, United States

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Pfizer Investigational Site

Dover, Ohio, United States

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Pfizer Investigational Site

Hamilton, Ontario, Canada

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Pfizer Investigational Site

Benesov U Prahy, , Czechia

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Pfizer Investigational Site

Hořovice, , Czechia

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Pfizer Investigational Site

Jablonec nad Nisou, , Czechia

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Pfizer Investigational Site

Pilsen, , Czechia

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Praha 1 - Nove Mesto, , Czechia

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Pfizer Investigational Site

Praha 6 - Hradcany, , Czechia

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Cairo, , Egypt

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Helsinki, , Finland

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Joensuu, , Finland

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Bordeaux, , France

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Villejuif, , France

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Budapest, , Hungary

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Budapest, , Hungary

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Nyíregyháza, , Hungary

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Szentes, , Hungary

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Tata, , Hungary

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Aviano (PN), , Italy

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Milan, , Italy

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Monterrey, Nuevo León, Mexico

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México D.F, , Mexico

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Lima, , Peru

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Lima, , Peru

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Manila, , Philippines

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Quezon City, , Philippines

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Bialystok, , Poland

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Gdansk, , Poland

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Kielce, , Poland

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Lodz, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Vsevolozhsk, Vsevolozhsk District, Leningrad Region, Russia

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Pfizer Investigational Site

Moscow, , Russia

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Pfizer Investigational Site

Saint Petersburg, , Russia

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Pfizer Investigational Site

Daegu, , South Korea

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Pfizer Investigational Site

Seoul, , South Korea

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Pfizer Investigational Site

Seoul, , South Korea

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Pfizer Investigational Site

Alcorcón, Madrid, Spain

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Pfizer Investigational Site

Lleida, , Spain

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Örebro, , Sweden

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Stockholm, , Sweden

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Kaohsiung Hsien, , Taiwan

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Pfizer Investigational Site

Taichung, , Taiwan

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Taipei, , Taiwan

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Pfizer Investigational Site

Rachathewi, Bangkok, Thailand

Site Status

Pfizer Investigational Site

Ratchathewi, Bangkok, Thailand

Site Status

Pfizer Investigational Site

Caracas, Distrito Federal, Venezuela

Site Status

Countries

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United States Canada Czechia Egypt Finland France Hungary Italy Mexico Peru Philippines Poland Russia South Korea Spain Sweden Taiwan Thailand Venezuela

References

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Sjolund KF, Yang R, Lee KH, Resnick M. Randomized study of pregabalin in patients with cancer-induced bone pain. Pain Ther. 2013 Jun;2(1):37-48. doi: 10.1007/s40122-013-0009-8. Epub 2013 Feb 26.

Reference Type DERIVED
PMID: 25135035 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0081128&StudyName=A%20Study%20To%20Evaluate%20Pregabalin%20In%20The%20Treatment%20Of%20Moderate%20To%20Severe%20Chronic%20Bone%20Pain%20Related%20To%20Metastatic%20Cancer

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

Other Identifiers

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A0081128

Identifier Type: -

Identifier Source: org_study_id

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