Management of Superficial Thrombophlebitis This study is ongoing, but not recruiting participants. First Received on December 8, 2005.

Last Updated on February 7, 2011 History of Changes Sponsor: University of Oklahoma

Collaborator: Pfizer

Information provided by: University of Oklahoma

ClinicalTrials.gov Identifier: NCT00264381 Purpose The purpose of this study is to test the hypothesis that Fragmin (dalteparin sodium) subcutaneously once daily for 7 days is more effective than Ibuprofen given orally three times daily for 7 days for the treatment of superficial thrombophlebitis (STP). Condition Intervention Phase

Superficial Thrombophlebitis Drug: Dalteparin sodium injection Phase IV Upper Extremity Superficial Thrombophlebitis Lower Extremity Superficial Thrombophlebitis Study Type: Study Design: Interventional Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment Management of Superficial Thrombophlebitis

Official Title:

Further study details as provided by University of Oklahoma:

Primary Outcome Measures: The primary outcome measure will be the degree of thrombus extension or symptomatically confirmed deep-vein thrombosis as assessed by objective ultrasound imaging on day 7-9 and 14-16. [ Time Frame: 7 - 9 days, followed by 14-16 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures: The secondary outcome measure will be improvement in pain as assessed by daily visual analog pain scale. Additional secondary outcome measure include major and minor bleeding secondary to dalteparin and ibuprofen treatment during the 3 month follow up. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: Study Start Date: Estimated Study Completion Date: Primary Completion Date:

150 October 2002 September 2011 September 2009 (Final data collection date for primary outcome measure)

Intervention Details: Drug: Dalteparin sodium injection Experimental group: dalteparin sodium 200units/kg subcutaneous on day one, followed by 10,000 units subcutaneous daily for six days plus placebo tablets taken orally three times daily for seven days. Control group: Ibuprofen 800mg orally three times daily for seven days plus placebo injection subcutaneous daily for seven days. Other Name: Fragmin Detailed Description: Superficial thrombophlebitis is a common problem and is thought to affect up to 20% of patients with varicose veins. In the absence of treatment, STP may cause its greatest morbidity with extension of thrombus into the deep venous system and resultant risk of pulmonary embolism. Current standard therapy for STP consists of local heat, elevation of the extremity, and nonsteroidal anti-inflammatory medication. However, no study to date has adequately evaluated the effectiveness of this therapy despite persistence and recurrence of symptoms of STP in many patients. The purpose of this study is to document the outcome of patients with objectively documented STP who are treated with NSAID therapy (standard care) verses those treated with lowmolecular weight heparin (dalteparin sodium) according to a pre-defined treatment regimen.

All patients with documented upper or lower STP will be screened. Each will have a complete baseline and risk factor assessment. All patients will be randomized in one of two treatment groups: (a) Experimental group who will receive Fragmin (dalteparin)fixed dose subcutaneously daily for 7 days or (b) Control group who will receive ibuprofen 800mg given orally three times daily for 7 days. All patients will receive study drug for a period of 1-2 weeks with reassessment of STP by ultrasound. All patients will participate for a period of 3 months with follow up visits at 7-9, and 14-16 day, and 1,3 months. Eligibility Ages Eligible for Study: Genders Eligible for Study: Accepts Healthy Volunteers: Criteria Inclusion Criteria:

18 Years and older Both No

Patients with confirmed upper or lower extremity superficial thrombophlebitis by ultrasound imaging

Exclusion Criteria:

Active, clinically significant bleeding Known hypersensitivity to NSAIDS, heparin or derivatives Currently pregnant or < 1 week post-partum Acquired bleeding diathesis Known inherited bleeding disorder Renal failure Extremes of weight unable to return for repeat diagnostic testing or follow-up visit Concurrent deep-vein thrombosis

Contacts and Locations Please refer to this study by its ClinicalTrials.gov identifier: NCT00264381

Locations United States, Oklahoma University of Oklahoma Health Science Center Oklahoma City, Oklahoma, United States, 73104 Department of Veterans Affairs Medical Center Oklahoma City, Oklahoma, United States, 73104

Sponsors and Collaborators University of Oklahoma Pfizer Investigators Principal Suman Rathbun, Investigator: M.D. More Information No publications provided Responsible Party: ClinicalTrials.gov Identifier: Other Study ID Numbers: Study First Received: Last Updated: Health Authority: University of Oklahoma ( Suman W. Rathbun, M.D./ Priniciple Investigator ) NCT00264381 History of Changes 10341, ORA-20030415 December 8, 2005 February 7, 2011 United States: Food and Drug Administration University of Oklahoma Medicine/Cardiovascular Section

Keywords provided by University of Oklahoma: Superficial Thrombophlebitis STP Fragmin Ibuprofen Additional relevant MeSH terms: Thrombophlebitis Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Phlebitis Peripheral Vascular Diseases Vasculitis Dalteparin

Superficial Thrombus Superficial Phlebitis phlebitis

Heparin, Low-Molecular-Weight Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents

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