Terminated
PHASE4
INTERVENTIONAL
NCT00381095
A Study To Evaluate Pregabalin In The Treatment Of Moderate To Severe Chronic Bone Pain Related To Metastatic Cancer
View on ClinicalTrials.gov
Updated Dec 15, 2025
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.
Interventions
Name:
Pregabalin
Type:
DRUG
Description:
Capsule, Flexible-dosing, Double-blind. Treatment duration is 28 days at 100-600 mg/day administered BID+ taper (6 days).
Name:
Placebo
Type:
DRUG
Description:
Placebo
Primary Outcomes
Measure:
Duration Adjusted Average Change (DAAC) From Baseline in Daily Worst Pain, Fixed Dosing Date to Day 28
TimeFrame:
Baseline, Fixed Dosing Date to Day 28 or Early Termination (ET)
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.
Trial Information
NCT ID
NCT00381095
Status
Terminated
Study Type
INTERVENTIONAL
Phases
PHASE4
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Last Updated
December 15, 2025