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Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)

An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5mg Subcutaneously) for the Treatment of Patients With Acute Symptomatic Isolated Superficial Thrombophlebitis of the Lower Limbs to Prevent Thromboembolic Complications

NCT00443053•GlaxoSmithKline

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (227)

GSK Investigational Site

Sofia, Bulgaria

GSK Investigational Site

Brno, Czechia

GSK Investigational Site

Olomouc, Czechia

GSK Investigational Site

Pilsen, Czechia

GSK Investigational Site

Prague, Czechia

GSK Investigational Site

Prague, Czechia

GSK Investigational Site

Prague, Czechia

GSK Investigational Site

Prague, Czechia

GSK Investigational Site

Prague, Czechia

GSK Investigational Site

Prague, Czechia

Key Dates

Start Date

March 1, 2007

Primary Completion Date

July 1, 2009

Completion Date

July 1, 2009

Last Updated

March 6, 2017

Enrollment

3,002

ACTUAL participants

Conditions

Thrombosis, Venous

Interventions

Fondaparinux 2.5mg or placebo

DRUG

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Thrombosis, Venous

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RECRUITING

Acute and Subacute Iliofemoral and/or Caval Deep Vein Thrombosis: Evaluation of Mechanical Thrombectomy Systems

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Thrombosis, Venous

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COMPLETED

Catheter Associated Asymptomatic Thrombosis in Intensive Care Unit

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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