A Randomized Placebo-Controlled Trial Of The Efficacy And Tolerability Of Flexibly Dosed Pregabalin In The Treatment Of Cancer-Induced Bone Pain
18 Years
N/A
Both
Bone Neoplasms, Pain, Intractable, Cancer
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 Site | Crestview Hills, Kentucky 41017 |
| Pfizer Investigational Site | Rochester, Minnesota 55905 |
| Pfizer Investigational Site | Cincinnait, Ohio 45236 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
