A Phase 4 interventional study of Dalteparin sodium injection in Superficial Thrombophlebitis, Upper Extremity Superficial Thrombophlebitis and Lower Extremity Superficial Thrombophlebitis, sponsored by University of Oklahoma. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-11-18.
Sponsored by University of Oklahoma · Phase 4, Interventional, and Treatment
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.
45 studies on the registry are indexed under Phlebitis; 9 are open to participants now.
This study's enrollment of 72 is below the median of 134 across 38 interventional studies indexed under Phlebitis.
Browse Phlebitis studies →University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Clinically significant
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Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ibuprofen 800mg tid X 7 days + additional 7 days determined by protocol
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.
Also known as: Fragmin
Thrombosis Progression and Venous Thromboembolism (VTE)
Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing
Time frame: 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.
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: Day 1, Day 14
Consecutive patients, inpatient and outpatient, with ultrasound confirmed superficial thrombophlebitis of the upper or lower extremity
| Milestone | Ibuprofen 800 mg Tid | Dalteparin 200 U/kg Then 10,000 U Daily |
|---|---|---|
| Started | 35 | 37 |
| Completed | 35 | 37 |
| Not completed | 0 | 0 |
Number of participants with bleeding events related to treatment
| participants | Ibuprofen 800 mg Tid | Dalteparin 200 U/kg Then 10,000 U Daily |
|---|---|---|
| Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up. | 0 | 0 |
Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing
| participants | Ibuprofen 800 mg Tid | Dalteparin 200 U/kg Then 10,000 U Daily |
|---|---|---|
| Thrombosis progression | 4 | 0 |
| VTE | 0 | 0 |
Symptomatic thrombosis extension (DVT) or pulmonary embolism at 3 months documented by radiologic testing.
| participants | Ibuprofen 800 mg Tid | Dalteparin 200 U/kg Then 10,000 U Daily |
|---|---|---|
| Thrombosis progression | 6 | 4 |
| VTE | 0 | 1 |
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
| units on a scale | Ibuprofen 800 mg Tid | Dalteparin 200 U/kg Then 10,000 U Daily |
|---|---|---|
| Change From Baseline to Day 14 in Pain Assessment | -2.28 ± 2.69 | -2.23 ± 2.01 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ibuprofen 800 mg Tid | — | 1/35 (2.9%) | 1/35 (2.9%) |
| Dalteparin 200 U/kg Then 10,000 U Daily | — | 0/37 (0%) | 2/37 (5.4%) |
| Event | Ibuprofen 800 mg Tid | Dalteparin 200 U/kg Then 10,000 U Daily |
|---|---|---|
| Major bleedingBlood and lymphatic system disorders | 1/35 | 0/37 |
| Event | Ibuprofen 800 mg Tid | Dalteparin 200 U/kg Then 10,000 U Daily |
|---|---|---|
| RashSkin and subcutaneous tissue disorders | 0/35 | 2/37 |
| TinnitusEar and labyrinth disorders | 1/35 | 0/37 |
| Age Continuous(years) | Ibuprofen 800 mg Tid | Dalteparin 200 U/kg Then 10,000 U Daily | Total |
|---|---|---|---|
| Mean | 52 (19 to 85) | 51 (28 to 88) | 51 (19 to 88) |
| Sex: Female, Male(Participants) | Ibuprofen 800 mg Tid | Dalteparin 200 U/kg Then 10,000 U Daily | Total |
|---|---|---|---|
| Female | 27 | 24 | 51 |
| Male | 8 | 13 | 21 |
| Region of Enrollment(participants) | Ibuprofen 800 mg Tid | Dalteparin 200 U/kg Then 10,000 U Daily | Total |
|---|---|---|---|
| United States | 35 | 37 | 72 |
The record gives a start of Oct 2002, a primary completion of Sep 2009 and a completion of Sep 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2013, 4 years 2 months after primary completion.
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Studies of the drug tested here: Dalteparin