Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00264381
Status:
COMPLETED
Last Update Posted:
2013-11-18
First Post:
2005-12-08
Brief Title:
Management of Superficial Thrombophlebitis
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
Management of Superficial Thrombophlebitis
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 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 dalteparinfixed 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 13 months
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 dalteparinfixed 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 13 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ORA-20030415 | OTHER | University of Oklahoma Office of Research Administration | None |