Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ORA-20030415 | Other Identifier | University of Oklahoma Office of Research Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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 (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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ibuprofen | Active Comparator | Ibuprofen 800mg tid X 7 days + additional 7 days determined by protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dalteparin sodium injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombosis Progression and Venous Thromboembolism (VTE) | Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing | Day 14 |
| Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months | Symptomatic thrombosis extension (DVT) or pulmonary embolism at 3 months documented by radiologic testing. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up. | Number of participants with bleeding events related to treatment | 3 months |
| Change From Baseline to Day 14 in Pain Assessment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Suman Rathbun, M.D. | University of Oklahoma Medicine/Cardiovascular Section | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Veterans Affairs Medical Center | Oklahoma City | Oklahoma | 73104 | United States | ||
| University of Oklahoma Health Science Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22360152 | Result | 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. |
Not provided
Not provided
Exclusion criteria: receiving anticoagulant therapy for more than 24 hours, concurrent DVT, active bleeding, hypersensitivity to NSAIDS, pregnant or <1 week post-partum, history of bleeding gastric ulcers, hemorrhagic CVA in last year, platelet count<100K, bleeding disorder, serum creatine > 2mg/dl, BP > 180/110, weight <40kg or >135kg
Consecutive patients, inpatient and outpatient, with ultrasound confirmed superficial thrombophlebitis of the upper or lower extremity
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ibuprofen 800 mg Tid | Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days + additional 7 days of same therapy based on result of ultrasound at day 7 |
| FG001 | Dalteparin 200 U/kg Then 10,000 U Daily | Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days + additional 7 days of same therapy based on results of ultrasound at day 7 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ibuprofen 800 mg Tid | Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days + additional 7 days of same therapy based on result of ultrasound at day 7 |
| BG001 | Dalteparin 200 U/kg Then 10,000 U Daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up. | Number of participants with bleeding events related to treatment | Posted | Number | participants | 3 months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ibuprofen 800 mg Tid | Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days + additional 7 days of same therapy based on result of ultrasound at day 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Major bleeding | Blood and lymphatic system disorders | Systematic Assessment | Not related to study treatment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suman Rathbun MD,MS | University of Oklahoma Health Sciences Center | 405271-4742 | 44773 | suman-rathbun@ouhsc.edu |
Not provided
| ID | Term |
|---|---|
| D010689 | Phlebitis |
| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014657 | Vasculitis |
Not provided
Not provided
| ID | Term |
|---|---|
| D017985 | Dalteparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
Change in pain at day 14 as measured by 11-point Box Pain Scale, 0 being the least amount of pain, and 10 the most amount of pain
| Day 1, Day 14 |
| Oklahoma City |
| Oklahoma |
| 73104 |
| United States |
Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days
+ additional 7 days of same therapy based on results of ultrasound at day 7
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Thrombosis Progression and Venous Thromboembolism (VTE) | Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing | Total number available for follow up | Posted | Number | participants | Day 14 |
|
|
|
| Primary | Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months | Symptomatic thrombosis extension (DVT) or pulmonary embolism at 3 months documented by radiologic testing. | Participants available for follow up | Posted | Number | participants | 3 months |
|
|
|
| Secondary | Change From Baseline to Day 14 in Pain Assessment | Change in pain at day 14 as measured by 11-point Box Pain Scale, 0 being the least amount of pain, and 10 the most amount of pain | Participants available at follow up | Posted | Mean | Standard Deviation | units on a scale | Day 1, Day 14 |
|
|
|
| 1 |
| 35 |
| 1 |
| 35 |
| EG001 | Dalteparin 200 U/kg Then 10,000 U Daily | Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days + additional 7 days of same therapy based on results of ultrasound at day 7 | 0 | 37 | 2 | 37 |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
| D002241 |
| Carbohydrates |