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A Randomized Placebo-Controlled Trial Of The Efficacy And Tolerability Of Flexibly Dosed Pregabalin In The Treatment Of Cancer-Induced Bone Pain


Phase 4
18 Years
N/A
Not Enrolling
Both
Bone Neoplasms, Pain, Intractable, Cancer

Thank you

Trial Information

A Randomized Placebo-Controlled Trial Of The Efficacy And Tolerability Of Flexibly Dosed Pregabalin In The Treatment Of 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A0081128

NCT ID:

NCT00381095

Start Date:

December 2006

Completion Date:

October 2010

Related Keywords:

  • Bone Neoplasms
  • Pain, Intractable
  • Cancer
  • Bone Neoplasms
  • Neoplasms
  • Pain, Intractable

Name

Location

Pfizer Investigational SiteCrestview Hills, Kentucky  41017
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteClearwater, Florida  33761