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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00443053

Purpose

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

Condition	Intervention	Phase
Superficial Thrombophlebitis	Drug: Fondaparinux 2.5mg or placebo	Phase III

MedlinePlus related topics: Deep Vein Thrombosis

Drug Information available for: ORG 31540 Fondaparinux sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Symptomatic venous thromboembolism (VTE) and/or death up to Day 45. VTE is defined in this study as any of the following symptomatic events: pulmonary embolism, deep-vein thrombosis or recurrence or extension of superficial thrombophlebitis. [ Time Frame: See outcome measure for details ]

Secondary Outcome Measures:

Symptomatic venous thrombolism and/or death up to Day 75. Each of the individual events making up venous thromboembolism up to Day 45 and up to Day 75. Bleeding events and arterial thromboembolic events up to Day 45 and up to Day 75. [ Time Frame: See outcome measure for details ]

Estimated Enrollment:	3000
Study Start Date:	March 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Fondaparinux 2.5mg: Active Comparator	Drug: Fondaparinux 2.5mg or placebo Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day
Placebo: Placebo Comparator	Drug: Fondaparinux 2.5mg or placebo Fondaparinux 2.5mg or matching placebo subcutaneously once daily up to day 45 day

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443053

Contacts

Contact: US GSK Clinical Trials Call Center

877-379-3718

Show 335 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	ART108053, EudraCT number 2006-004774-27
Study First Received:	March 2, 2007
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00443053 History of Changes
Health Authority:	Netherlands: Medicines Evaluation Board (MEB)

Keywords provided by GlaxoSmithKline:

superficial thrombophlebitis
superficial vein thrombosis
thrombosis

fondaparinux
venous thromboembolism treatment
deep vein thrombosis

Study placed in the following topic categories:

Anticoagulants
Peripheral Vascular Diseases
Vasculitis
Vascular Diseases
Fibrinolytic Agents
Fondaparinux
Cardiovascular Agents
Venous Thromboembolism
Thrombosis

Thromboembolism
Org 31540
Fibrin Modulating Agents
Embolism and Thrombosis
Embolism
Phlebitis
Venous Thrombosis
Thrombophlebitis

Additional relevant MeSH terms:

Peripheral Vascular Diseases
Vasculitis
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Fondaparinux
Cardiovascular Agents
Pharmacologic Actions

Thrombosis
Org 31540
Fibrin Modulating Agents
Embolism and Thrombosis
Therapeutic Uses
Phlebitis
Venous Thrombosis
Cardiovascular Diseases
Thrombophlebitis

ClinicalTrials.gov processed this record on May 07, 2009