Superficial ThrombophlebitisPhase 4NCT00264381
Management of Superficial Thrombophlebitis
A Phase 4 study testing Dalteparin sodium injection in people with Superficial Thrombophlebitis and Upper Extremity Superficial Thrombophlebitis, run by University of Oklahoma at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Superficial Thrombophlebitis, Upper Extremity Superficial Thrombophlebitis, Lower Extremity Superficial Thrombophlebitis
- What is being tested?
- Dalteparin sodium injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2002to Sep 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with confirmed upper or lower extremity superficial thrombophlebitis by ultrasound imaging
Who cannot join
- 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
Show all 9Show fewer
- Extremes of weight
- unable to return for repeat diagnostic testing or follow-up visit
- Concurrent deep-vein thrombosis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Department of Veterans Affairs Medical Center
Oklahoma City, Oklahoma, 73104
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104
About this study
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).
Read the 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 (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
- Superficial Thrombophlebitis, Upper Extremity Superficial Thrombophlebitis, Lower Extremity Superficial Thrombophlebitis
- Being tested
- Dalteparin sodium injection
- Keywords
- Superficial Thrombophlebitis, STP, Fragmin, Ibuprofen, Superficial Thrombus, Superficial Phlebitis, phlebitis
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalteparin sodium injectionDrug
Also called Fragmin
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.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Active comparator | Ibuprofen 800mg tid X 7 days + additional 7 days determined by protocol Receives: Drug: Dalteparin sodium injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombosis Progression and Venous Thromboembolism (VTE)
Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing
Measured: 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.
Measured: 3 months
Secondary outcomes (2)
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
Measured: 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
Measured: Day 1, Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2005 (estimated)
- Study startOct 2002
- Primary completionSep 2009
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Superficial ThrombophlebitisStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Suman Rathbun, M.D., Principal investigator, University of Oklahoma Medicine/Cardiovascular Section
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264381
- Sponsor's protocol ID
- 10341
- Other IDs
- ORA-20030415
- Status last verified
- Nov 2013
- First submitted
- 8 Dec 2005
- Last updated
- 18 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22360152
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Superficial Thrombophlebitis
- ClinicalTrials.gov ID
- NCT00264381
- Acronym / sponsor ID
- 10341
- Conditions
- Superficial Thrombophlebitis, Upper Extremity Superficial Thrombophlebitis, Lower Extremity Superficial Thrombophlebitis
- Keywords
- Superficial Thrombophlebitis, STP, Fragmin, Ibuprofen, Superficial Thrombus, Superficial Phlebitis, phlebitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2002
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 12 Dec 2005 (estimated)
- Results
- Posted 18 Nov 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Active comparator | Drug: Dalteparin sodium injectionIbuprofen 800mg tid X 7 days + additional 7 days determined by protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with confirmed upper or lower extremity superficial thrombophlebitis by ultrasound imaging
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dalteparin sodium injectionAlso: FragminExperimental 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. | Drug | Ibuprofen |
Primary outcome
Thrombosis Progression and Venous Thromboembolism (VTE)
Time frame: Day 14
Thrombosis progression and deep vein thrombosis at day 14 by ultrasound testing
Thrombosis Progression or Venous Thromboembolism (VTE) at 3 Months
Time frame: 3 months
Symptomatic thrombosis extension (DVT) or pulmonary embolism at 3 months documented by radiologic testing.
2 secondary outcomes
Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up.
Time frame: 3 months
Change From Baseline to Day 14 in Pain Assessment
Time frame: Day 1, Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22360152Rathbun 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suman Rathbun, M.D. principal investigator
University of Oklahoma Medicine/Cardiovascular Section
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dalteparin sodium injection in people with Superficial Thrombophlebitis and Upper Extremity Superficial Thrombophlebitis, run by University of Oklahoma at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombosis Progression and Venous Thromboembolism (VTE) (time frame: Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00264381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2013.