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

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NCT00381095

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Study Location
Pfizer Investigational Site
Celebration, Florida, 34747, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bone Neoplasms, Intractable Pain, Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Bone Neoplasms, Intractable Pain, CancerA Study To Evaluate Pregabalin In The Treatment Of Moderate To Severe Chronic Bone Pain Related To Metastatic Cancer
NCT00381095
  1. Celebration, Florida
  2. Kissimmee, Florida
  3. Pensacola, Florida
  4. Pensacola, Florida
  5. Louisville, Kentucky
  6. Edina, Minnesota
  7. Canton, Ohio
  8. Dover, Ohio
  9. Hamilton, Ontario
  10. Benesov U Prahy,
  11. Horovice,
  12. Jablonec nad Nisou,
  13. Plzen,
  14. Praha 1 - Nove Mesto,
  15. Praha 6 - Hradcany,
  16. Cairo,
  17. Helsinki,
  18. Joensuu,
  19. Bordeaux Cedex,
  20. Villejuif,
  21. Budapest,
  22. Budapest,
  23. Nyiregyhaza,
  24. Szentes,
  25. Tata,
  26. Aviano (PN),
  27. Milano,
  28. Daegu,
  29. Seoul,
  30. Seoul,
  31. Monterrey, Nuevo Leon
  32. México D.F,
  33. Lima,
  34. Lima,
  35. Manila,
  36. Quezon City,
  37. Bialystok,
  38. Gdansk,
  39. Kielce,
  40. Lodz,
  41. Warszawa,
  42. Warszawa,
  43. Vsevolozhsk, Vsevolozhsk District, Leningrad Region
  44. Moscow,
  45. Saint-Petersburg,
  46. Alcorcon, Madrid
  47. Lleida,
  48. Orebro,
  49. Stockholm,
  50. Kaohsiung Hsien,
  51. Taichung City,
  52. Taipei,
  53. Rachathewi, Bangkok
  54. Ratchathewi, Bangkok
  55. Caracas, Distrito Capital
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Evaluate Pregabalin In The Treatment Of Moderate To Severe Chronic Bone Pain Related To Metastatic Cancer
Official Title  ICMJE A Randomized Placebo-Controlled Trial Of The Efficacy And Tolerability Of Flexibly Dosed Pregabalin In The Treatment Of Cancer-Induced Bone Pain
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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Bone Neoplasms
  • Pain, Intractable
  • Cancer
Intervention  ICMJE
  • Drug: Pregabalin
    Capsule, Flexible-dosing, Double-blind. Treatment duration is 28 days at 100-600 mg/day administered BID+ taper (6 days).
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: 1
    flexible dosing
    Intervention: Drug: Pregabalin
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications * Sjölund 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 19, 2011)		152
Original Enrollment  ICMJE
 (submitted: September 25, 2006)		310
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Czechia,   Egypt,   Finland,   France,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Peru,   Philippines,   Poland,   Russian Federation,   Spain,   Sweden,   Taiwan,   Thailand,   United States,   Venezuela
Removed Location Countries Bulgaria,   Czech Republic,   Denmark
 
Administrative Information
NCT Number  ICMJE NCT00381095
Other Study ID Numbers  ICMJE A0081128
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP