Conditions: Thrombosis, Venous
Keywords: superficial vein thrombosis superficial thrombophlebitis fondaparinux deep vein thrombosis venous thromboembolism treatment thrombosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3002
Healthy volunteers: no

Brief summary:
To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.

Detailed description:
Comparison of ARIXTRA™ in lower LImb Superficial Thrombophlebitis with placebo (CALISTO). An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5 mg subcutaneously) for the Treatment of Patients with Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to prevent Thromboembolic Complications

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Fondaparinux 2.5mg or placebo
Intervention descriptions: intervention 1: Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day

Protocol document: