Evaluation Of Fondaparinux (Also Called ARIXTRA) 2.5 mg Subcutaneously Once Daily For The Treatment Of Superficial Thrombophlebitis (Also Known As Superficial Vein Thrombosis)
Launched by GLAXOSMITHKLINE · Mar 2, 2007
Trial Information
Current as of July 25, 2025
Completed
Keywords
ClinConnect Summary
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
Gender
ALL
Eligibility 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
About Glaxosmithkline
GlaxoSmithKline (GSK) is a global healthcare company dedicated to improving the quality of human life by enabling people to do more, feel better, and live longer. With a strong focus on research and development, GSK specializes in pharmaceuticals, vaccines, and consumer health products. The company is committed to advancing innovative therapies and preventive measures across various therapeutic areas, including respiratory, oncology, immunology, and infectious diseases. GSK's collaborative approach and rigorous clinical trial processes underscore its dedication to delivering safe and effective healthcare solutions that meet the needs of patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milano, Lombardia, Italy
Pavia, Lombardia, Italy
Padova, Veneto, Italy
Palma De Mallorca, , Spain
Napoli, Campania, Italy
Presov, , Slovakia
Pécs, , Hungary
Ashkelon, , Israel
Leer, Niedersachsen, Germany
Leipzig, Sachsen, Germany
Larisa, , Greece
Thessaloniki, , Greece
Miskolc, , Hungary
Bydgoszcz, , Poland
San Juan De Alicante, , Spain
Augsburg, Bayern, Germany
Sabadell (Barcelona), , Spain
Olomouc, , Czech Republic
Jena, Thueringen, Germany
Rimini, Emilia Romagna, Italy
Muenchen, Bayern, Germany
Bern, , Switzerland
Afula, , Israel
Kfar Saba, , Israel
Amsterdam, , Netherlands
Perm, , Russian Federation
St. Petersburgh, , Russian Federation
Tomsk, , Russian Federation
Getafe, , Spain
Annecy, , France
Arras, , France
Osnabrueck, Niedersachsen, Germany
Székesfehérvár, , Hungary
Alkmaar, , Netherlands
Den Haag, , Netherlands
Maastricht, , Netherlands
Bratislava, , Slovakia
Zilina, , Slovakia
Gijon, , Spain
Marid, , Spain
Wuerzburg, Bayern, Germany
Nitra, , Slovakia
Heidelberg, Baden Wuerttemberg, Germany
Grudziadz, , Poland
Ryazan, , Russian Federation
Yaroslavl, , Russian Federation
Valencia, , Spain
Lviv, , Ukraine
Athens, , Greece
Bialystok, , Poland
Praha 4, , Czech Republic
Nordhausen, Thueringen, Germany
Noerdlingen, Bayern, Germany
Ludwigshafen, Rheinland Pfalz, Germany
Eschwege, Hessen, Germany
Frankenthal, Rheinland Pfalz, Germany
Rostock, Mecklenburg Vorpommern, Germany
Oberhausen, Nordrhein Westfalen, Germany
Berlin, , Germany
Praha 2, , Czech Republic
Daugavpils, , Latvia
Tumen, , Russian Federation
Ufa, , Russian Federation
Bruderholz, , Switzerland
Luzern, , Switzerland
Avila, , Spain
Haifa, , Israel
Tel Aviv, , Israel
Irkutsk, , Russian Federation
Petach Tikva, , Israel
Donetsk, , Ukraine
Grenoble, , France
Debrecen, , Hungary
Annonay, , France
Sofia, , Bulgaria
Neuss, Nordrhein Westfalen, Germany
Chemnitz, Sachsen, Germany
Dresden, Sachsen, Germany
Mataro, , Spain
Zamora, , Spain
Venezia, Veneto, Italy
Montpellier, , France
Clermont Ferrand, , France
Hamburg, , Germany
Chieti Scalo, Abruzzo, Italy
Arkhangelsk, , Russian Federation
Ekaterinburg, , Russian Federation
Amiens, , France
Valenciennes, , France
Piacenza, Emilia Romagna, Italy
Toulon, , France
Firenze, Toscana, Italy
Moscow, , Russian Federation
Bardejov, , Slovakia
Kosice, , Slovakia
Gyula, , Hungary
Segovia, , Spain
Neunkirchen, Saarland, Germany
Kaposvár, , Hungary
Saku, , Estonia
Tallinn, , Estonia
Toulouse, , France
Nyiregyháza, , Hungary
Zalaegerszeg, , Hungary
Brno, , Czech Republic
Riga, , Latvia
Plzen, , Czech Republic
Praha 10, , Czech Republic
Praha 5, , Czech Republic
Praha 6, , Czech Republic
Ricany, , Czech Republic
Tabor, , Czech Republic
Tartu, , Estonia
Abbeville, , France
Ales, , France
Bordeaux, , France
Brest, , France
Nice, , France
Nîmes Cedex 9, , France
Saint Aubin Sur Scie, , France
Saint Priest En Jarez, , France
Tarbes, , France
Villeurbanne, , France
Baesweiler, Baden Wuerttemberg, Germany
Freiburg, Baden Wuerttemberg, Germany
Karlsbad, Baden Wuerttemberg, Germany
Karlsruhe, Baden Wuerttemberg, Germany
Lauffen, Baden Wuerttemberg, Germany
Grossheirath, Bayern, Germany
Hemau, Bayern, Germany
Muehldorf, Bayern, Germany
Nuernberg, Bayern, Germany
Dahlwitz Hoppegarten, Brandenburg, Germany
Potsdam, Brandenburg, Germany
Darmstadt, Hessen, Germany
Frankfurt, Hessen, Germany
Wiesbaden, Hessen, Germany
Bad Bevensen, Niedersachsen, Germany
Essen Kettwig, Nordrhein Westfalen, Germany
Koeln Junkersdorf, Nordrhein Westfalen, Germany
Koeln, Nordrhein Westfalen, Germany
Moenchengladbach, Nordrhein Westfalen, Germany
Waldbroel, Nordrhein Westfalen, Germany
Wuppertal, Nordrhein Westfalen, Germany
Neustadt, Rheinland Pfalz, Germany
Kirchberg, Sachsen, Germany
Altenburg, Thueringen, Germany
Alexandroupolis, , Greece
Heraklion, , Greece
Melissia Athens, , Greece
Bekescsaba, , Hungary
Budapest, , Hungary
Esztergom, , Hungary
Szikszó, , Hungary
Safed, , Israel
Reggio Emilia, Emilia Romagna, Italy
Palermo, Sicilia, Italy
Weerselo, , Netherlands
Gniewkowo, , Poland
Poznan, , Poland
Wroclaw, , Poland
Barnaul, , Russian Federation
Kemerovo, , Russian Federation
Kursk, , Russian Federation
Lipetsk, , Russian Federation
Rostov Na Donu, , Russian Federation
Saint Petersburg, , Russian Federation
Samara, , Russian Federation
Saratov, , Russian Federation
Stavropol, , Russian Federation
Voronezh, , Russian Federation
Boadilla Del Monte (Madrid), , Spain
Cartagena (Murcia), , Spain
Hospitalet De Llobregat, , Spain
Valladolid, , Spain
Fribourg, , Switzerland
Geneve, , Switzerland
Lausanne, , Switzerland
Zuerich, , Switzerland
Dnipropetrovsk, , Ukraine
Ivano Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Sevastopol, , Ukraine
Uzhgorod, , Ukraine
Vinnitsa, , Ukraine
Zaporizhzhya, , Ukraine
Patients applied
Trial Officials
GSK Clinical Trials
Study Director
GlaxoSmithKline
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials