Management of Superficial Thrombophlebitis

NCT00264381

Last updated date
Study Location
Department of Veterans Affairs Medical Center
Oklahoma City, Oklahoma, 73104, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Superficial Thrombophlebitis, Upper Extremity Superficial Thrombophlebitis, Lower Extremity Superficial Thrombophlebitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Superficial Thrombophlebitis, Upper Extremity Superficial Thrombophlebitis, Lower Extremity Superficial ThrombophlebitisManagement of Superficial Thrombophlebitis
NCT00264381
  1. Oklahoma City, Oklahoma
  2. Oklahoma City, Oklahoma
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Management of Superficial Thrombophlebitis
Official Title  ICMJE Management of Superficial Thrombophlebitis
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 (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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Superficial Thrombophlebitis
  • Upper Extremity Superficial Thrombophlebitis
  • Lower Extremity Superficial Thrombophlebitis
Intervention  ICMJE 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.
Other Name: Fragmin
Study Arms  ICMJE Active Comparator: Ibuprofen
Ibuprofen 800mg tid X 7 days + additional 7 days determined by protocol
Intervention: Drug: Dalteparin sodium injection
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 27, 2012)
72
Original Enrollment  ICMJE
 (submitted: December 8, 2005)
150
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00264381
Other Study ID Numbers  ICMJE 10341
ORA-20030415 ( Other Identifier: University of Oklahoma Office of Research Administration )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oklahoma
Study Sponsor  ICMJE University of Oklahoma
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Suman Rathbun, M.D.University of Oklahoma Medicine/Cardiovascular Section
PRS Account University of Oklahoma
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP