Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
72 participants
INTERVENTIONAL
2002-10-31
2011-09-30
Brief Summary
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Detailed Description
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Current standard therapy for STP consists of local heat, elevation of the extremity, and non-steroidal 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 low-molecular 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ibuprofen
Ibuprofen 800mg tid X 7 days + additional 7 days determined by protocol
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Suman Rathbun, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma Medicine/Cardiovascular Section
Locations
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Department of Veterans Affairs Medical Center
Oklahoma City, Oklahoma, United States
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, United States
Countries
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References
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Rathbun SW, Aston CE, Whitsett TL. A randomized trial of dalteparin compared with ibuprofen for the treatment of superficial thrombophlebitis. J Thromb Haemost. 2012 May;10(5):833-9. doi: 10.1111/j.1538-7836.2012.04669.x.
Other Identifiers
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ORA-20030415
Identifier Type: OTHER
Identifier Source: secondary_id
10341
Identifier Type: -
Identifier Source: org_study_id