Status:
TERMINATED
A Study To Evaluate Pregabalin In The Treatment Of Moderate To Severe Chronic Bone Pain Related To Metastatic Cancer
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Bone Neoplasms
Pain, Intractable
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00381095
Start Date
December 1 2006
End Date
October 1 2010
Last Update
January 20 2021
Active Locations (55)
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1
Pfizer Investigational Site
Celebration, Florida, United States, 34747
2
Pfizer Investigational Site
Kissimmee, Florida, United States, 34741
3
Pfizer Investigational Site
Pensacola, Florida, United States, 32504
4
Pfizer Investigational Site
Pensacola, Florida, United States, 32514