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

NCT00381095 | Terminated Phase 4 Results DMC

• 1 other identifier: A0081128
• Study Type: interventional
• Target: 152
• Locations: 19 countries
• Sites: 55

Brief Summary

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.

Conditions

Bone Neoplasms; Pain, Intractable; Cancer

Outcome Measures

Primary Outcomes (1)

• Duration Adjusted Average Change (DAAC) From Baseline in Daily Worst Pain, Fixed Dosing Date to Day 28

  DAAC from baseline based on Numeric Rating Scale (NRS) score for Worst Pain at Reference site from the last day dose adjustment was needed (fixed dosing date) to day 28. DAAC defined as area under the curve (AUC) of change in worst pain divided by pain measurement duration. Pain rated on an 11 point scale ranged from 0 (no pain) to 10 (worst possible pain). Change was week x minus baseline.

  Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET)

Secondary Outcomes (12)

• DAAC From Baseline in Daily Worst Pain, Days 1 Through 28

  Baseline, Days 1 through 28 or ET

• DAAC From Baseline in Daily Worst Pain, Day 1 to End of Dose Adjustment

  Baseline, Day 1 to End of Dose Adjustment or ET

• DAAC From Baseline in Daily Worst Pain 14 Days After Fixed Dosing Date Up to Day 28

  Baseline, 14 Days After Fixed Dosing Date up to Day 28 or ET

• Change From Baseline in Modified Brief Pain Inventory (mBPI-sf) Pain Severity Index Score at Week 4

  Baseline, Week 4 or ET

• Change From Baseline in mBPI-sf Interference Index Score at Week 4

  Baseline, Week 4 or ET

Study Arms (2)

1

EXPERIMENTAL

flexible dosing

Drug: Pregabalin

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Pregabalin DRUG

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

1

Placebo DRUG

Placebo

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (55)

Pfizer Investigational Site

Celebration, Florida, 34747, United States

Location

Pfizer Investigational Site

Kissimmee, Florida, 34741, United States

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Pensacola, Florida, 32504, United States

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Pensacola, Florida, 32514, United States

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Louisville, Kentucky, 40202, United States

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Edina, Minnesota, 55435, United States

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Canton, Ohio, 44718, United States

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Dover, Ohio, 44622, United States

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Hamilton, Ontario, L8V 5C2, Canada

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Benesov U Prahy, 256 30, Czechia

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Hořovice, 268 31, Czechia

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Jablonec nad Nisou, 466 60, Czechia

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Pilsen, 301 00, Czechia

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Praha 1 - Nove Mesto, 110 00, Czechia

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Praha 6 - Hradcany, 160 00, Czechia

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Cairo, 11796, Egypt

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Helsinki, 00029, Finland

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Joensuu, 80210, Finland

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Bordeaux, 33076, France

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Villejuif, 94805, France

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Budapest, 1106, Hungary

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Budapest, 1125, Hungary

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Nyíregyháza, 4400, Hungary

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Szentes, 6600, Hungary

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Tata, 2890, Hungary

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Aviano (PN), 33081, Italy

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Milan, 20133, Italy

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Monterrey, Nuevo León, 064460, Mexico

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México D.F, 14080, Mexico

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Lima, L-41, Peru

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Lima, L13, Peru

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Manila, 1015, Philippines

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Quezon City, 1102, Philippines

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Bialystok, 15-748, Poland

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Gdansk, 80-208, Poland

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Kielce, 25-734, Poland

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Lodz, 90-251, Poland

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Warsaw, 00-909, Poland

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Warsaw, 02-781, Poland

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Vsevolozhsk, Vsevolozhsk District, Leningrad Region, 188640, Russia

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Moscow, 125284, Russia

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Saint Petersburg, 197089, Russia

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Daegu, 705-717, South Korea

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Seoul, 110-744, South Korea

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Seoul, 152-703, South Korea

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Alcorcón, Madrid, 28922, Spain

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Lleida, 25198, Spain

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Örebro, 701 85, Sweden

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Stockholm, 171 76, Sweden

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Kaohsiung Hsien, 833, Taiwan

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Taichung, 40705, Taiwan

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Taipei, 100, Taiwan

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Pfizer Investigational Site

Rachathewi, Bangkok, 10400, Thailand

Location

Pfizer Investigational Site

Ratchathewi, Bangkok, 10400, Thailand

Location

Pfizer Investigational Site

Caracas, Distrito Federal, 1010, Venezuela

Location

Related Publications (1)

• 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.

  PMID: 25135035 DERIVED

Related Links

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

MeSH Terms

Conditions

Bone Neoplasms; Pain, Intractable; Neoplasms

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Efficacy parameters baseline=the last non-missing observation, up to the baseline visit for that efficacy parameter. Baseline mBPI scores=average score in week preceding randomization, minimum 4 datapoints. No formal hypothesis testing conducted.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2006
• First Posted: September 27, 2006
• Study Start: December 1, 2006
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 20, 2021
• Results First Posted: September 27, 2011

Record last verified: 2019-04

Locations

SE (2); PH (2); KR (3); IT (2); FR (2); PE (2); FI (2); ES (2); TW (3); PL (6); TH (2); VE (1); EG (1); RU (3); CZ (6); HU (5); CA (1); ME (2); US (8)