Conditions: Bone Neoplasms Pain, Intractable Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 152
Healthy volunteers: no

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.

Arms:
arm 1: flexible dosing arm 2: None

Interventions: intervention 1: Pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: Capsule, Flexible-dosing, Double-blind. Treatment duration is 28 days at 100-600 mg/day administered BID+ taper (6 days). intervention 2: Placebo

Protocol document: