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

Last updated on May 11, 2018

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Study Location
Pfizer Investigational Site
Celebration, Florida, 34747 United States
Contact
1-800-718-1021
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.

NCT00381095
Pfizer
Terminated
A Study To Evaluate Pregabalin In The Treatment Of Moderate To Severe Chronic Bone Pain Related To Metastatic Cancer

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A Study To Evaluate Pregabalin In The Treatment Of Moderate To Severe Chronic Bone Pain Related To Metastatic Cancer
A Randomized Placebo-Controlled Trial Of The Efficacy And Tolerability Of Flexibly Dosed Pregabalin In The Treatment Of Cancer-Induced Bone Pain
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Bone Neoplasms
  • Pain, Intractable
  • Cancer
  • 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
  • Experimental: 1
    flexible dosing
    Intervention: Drug: Pregabalin
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
152
October 2010
October 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Czech Republic,   Egypt,   Finland,   France,   Hungary,   Italy,   Korea, Republic of,   Mexico,   Peru,   Philippines,   Poland,   Russian Federation,   Spain,   Sweden,   Taiwan,   Thailand,   United States,   Venezuela
Bulgaria,   Denmark
 
NCT00381095
A0081128
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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