NCT00264381

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2002

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 12, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

November 18, 2013

Completed
Last Updated

November 18, 2013

Status Verified

November 1, 2013

Enrollment Period

6.9 years

First QC Date

December 8, 2005

Results QC Date

November 14, 2013

Last Update Submit

November 14, 2013

Conditions

Superficial ThrombophlebitisUpper Extremity Superficial ThrombophlebitisLower Extremity Superficial Thrombophlebitis

Keywords

Superficial ThrombophlebitisSTPFragminIbuprofenSuperficial ThrombusSuperficial Phlebitisphlebitis

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (2)

  • Major and Minor Bleeding Secondary to Dalteparin and Ibuprofen Treatment During the 3 Month Follow up.

    3 months

  • Change From Baseline to Day 14 in Pain Assessment

    Day 1, Day 14

Study Arms (1)

Ibuprofen

ACTIVE COMPARATOR

Ibuprofen 800mg tid X 7 days + additional 7 days determined by protocol

Drug: Dalteparin sodium injection

Interventions

Dalteparin sodium injectionDRUG

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
Ibuprofen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with confirmed upper or lower extremity superficial thrombophlebitis by ultrasound imaging

You may not qualify if:

  • 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
  • Extremes of weight
  • unable to return for repeat diagnostic testing or follow-up visit
  • Concurrent deep-vein thrombosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Veterans Affairs Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

  • 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.

    PMID: 22360152RESULT

MeSH Terms

Conditions

Phlebitis

Interventions

Dalteparin

Condition Hierarchy (Ancestors)

Peripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesVasculitis

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Results Point of Contact

Title
Suman Rathbun MD,MS
Organization
University of Oklahoma Health Sciences Center
suman-rathbun@ouhsc.edu
405271-4742

Study Officials

  • Suman Rathbun, M.D.

    University of Oklahoma Medicine/Cardiovascular Section

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2005

First Posted

December 12, 2005

Study Start

October 1, 2002

Primary Completion

September 1, 2009

Study Completion

September 1, 2011

Last Updated

November 18, 2013

Results First Posted

November 18, 2013

Record last verified: 2013-11

Locations

US(2)