Last updated: 11/07/2018 15:42:37
Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: To evaluate fondaparinux 2.5mg subcutaneously once daily for 45 days in the treatment of acute (recent) superficial thrombophlebitis.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of participants with at least on event of venous thromboembolism (VTE) and/or death from any cause recorded up to Day 47
Timeframe: Baseline to Day 47
Secondary outcomes:
Number of participants with at least one event of venous thromboembolism (VTE) and/or death from any cause recorded up to Day 77
Timeframe: Baseline to Day 77
Number of Participants with at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77
Timeframe: Days 47 and 77
Number of participants who required surgery to treat superficial vein thrombosis recurrence at Days 47 and 77
Timeframe: Days 47 and 77
Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77
Timeframe: Days 47 (or last dose plus 4 days) and 77
Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77
Timeframe: Days 47 (or last dose plus 4 days) and 77
Number of any adjudicated bleeding events at Days 47 and 77
Timeframe: Days 47 (or last dose plus 4 days) and 77
Interventions:
Drug: Fondaparinux 2.5mg or placebo
Enrollment:
3002
Observational study model:
Not applicable
Primary completion date:
2009-31-07
Time perspective:
Not applicable
Clinical publications:
Alain Leizorovicz, François Becker, Andrea Buchmüller, Isabelle Quéré, Paolo Prandoni, Hervé Decousus. Clinical relevance of symptomatic superficial-vein thrombosis extension: lessons from the CALISTO study. Blood. 2103;122(10):1724-9.
Decousus H, Prandoni P, Mismetti P, et al;. CALISTO Study Group. Fondaparinux in the treatment of lower-limb superficial-vein thrombosis. . N Engl J Med. 2010;363(13):1222-32.
Medical condition
Thrombosis, Venous
Product
fondaparinux sodium
Collaborators
GSK
Study date(s)
March 2007 to July 2009
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Acute symptomatic superficial thrombophlebitis of the lower limbs at least 5 cm long diagnosed by compression ultrasound.
- Superficial thrombophlebitis that is within 3 cm from the sapheno-femoral junction,
- deep vein thrombosis on ultrasound exam,
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Leipzig, Sachsen, Germany, 04109
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Reggio Emilia, Emilia-Romagna, Italy, 42100
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Essen-Kettwig, Nordrhein-Westfalen, Germany, 45219
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79108
Status
Study Complete
Location
GSK Investigational Site
Oberhausen, Nordrhein-Westfalen, Germany, 46145
Status
Study Complete
Location
GSK Investigational Site
Praha 10, Czech Republic, 101 00
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Karlsruhe, Baden-Wuerttemberg, Germany, 76133
Status
Study Complete
Location
GSK Investigational Site
Altenburg, Thueringen, Germany, 04600
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wuppertal, Nordrhein-Westfalen, Germany, 42275
Status
Study Complete
Location
GSK Investigational Site
Potsdam, Brandenburg, Germany, 14482
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Moenchengladbach, Nordrhein-Westfalen, Germany, 41065
Status
Study Complete
Location
GSK Investigational Site
Muenchen, Bayern, Germany, 80336
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rimini, Emilia-Romagna, Italy, 47900
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Darmstadt, Hessen, Germany, 64283
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Karlsbad, Baden-Wuerttemberg, Germany, 76307
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bad Bevensen, Niedersachsen, Germany, 29549
Status
Study Complete
Location
GSK Investigational Site
Baesweiler, Baden-Wuerttemberg, Germany, 52499
Status
Study Complete
Location
GSK Investigational Site
Chemnitz, Sachsen, Germany, 09130
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Neustadt, Rheinland-Pfalz, Germany, 67434
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Boadilla del Monte (Madrid), Spain, 28660
Status
Study Complete
Location
GSK Investigational Site
Ludwigshafen, Rheinland-Pfalz, Germany, 67059
Status
Study Complete
Location
GSK Investigational Site
Piacenza, Emilia-Romagna, Italy, 29100
Status
Study Complete
Location
GSK Investigational Site
Lauffen, Baden-Wuerttemberg, Germany, 74348
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Dahlwitz-Hoppegarten, Brandenburg, Germany, 15366
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18059
Status
Study Complete
Location
GSK Investigational Site
Hamburg, Hamburg, Germany, 22761
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Grossheirath, Bayern, Germany, 96269
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Koeln-Junkersdorf, Nordrhein-Westfalen, Germany, 50858
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Nordhausen, Thueringen, Germany, 99734
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Frankfurt, Hessen, Germany, 60322
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Osnabrueck, Niedersachsen, Germany, 49074
Status
Study Complete
Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 50760
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kirchberg, Sachsen, Germany, 08107
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
Status
Study Complete
Location
GSK Investigational Site
Waldbroel, Nordrhein-Westfalen, Germany, 51545
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Heidelberg, Baden-Wuerttemberg, Germany, 69120
Status
Study Complete
Location
GSK Investigational Site
Neuss, Nordrhein-Westfalen, Germany, 41460
Status
Terminated/Withdrawn
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-31-07
Actual study completion date
2009-31-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website