Status:
COMPLETED
Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Thrombosis, Venous
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 Stu...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long diagnosed by compression ultrasound.
- Exclusion criteria:
- Superficial thrombophlebitis that is within 3 cm from the sapheno-femoral junction,
- deep vein thrombosis on ultrasound exam, deep vein thrombosis or pulmonary embolism within last 6 months, treatment for cancer during last 6 months,
- anticoagulant medication for more than 48 hours prior to inclusion,
- need for oral non-steroidal anti-inflammatory drugs during the study, significant bleeding event during past month,
- major surgery within last 3 months, low platelet count (below 100×109/L),
- kidney disease (Calculated creatinine clearance \< 30 mL/min), woman of child-bearing potential not using reliable contraceptive method
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
3002 Patients enrolled
Trial Details
Trial ID
NCT00443053
Start Date
March 1 2007
End Date
July 1 2009
Last Update
March 6 2017
Active Locations (227)
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1
GSK Investigational Site
Sofia, Bulgaria, 1309
2
GSK Investigational Site
Brno, Czechia, 656 91
3
GSK Investigational Site
Olomouc, Czechia, 775 20
4
GSK Investigational Site
Pilsen, Czechia, 323 18