Study to Determine Effective Dosing of Fondaparinux in Obese Persons

Morbid Obesity Clinical Trial

Official title: Thromboprophylaxis in the Morbidly Obese With Weight Based Dosing of Fondaparinux: A Pharmacodynamic Study

Status Withdrawn

Clinical Trial Summary

This is a prospective open-label study comparing two dosing regimens of fondaparinux, which is used to prevent deep vein thrombosis, in morbidly obese volunteers.

Clinical Trial Description

The incidence of obesity is growing at an alarming pace and has reached epidemic proportions. Subjects who are more than 100 pounds over their ideal body weight are classified as being morbidly obese and are considered to carry a high risk for multiple chronic medical conditions that impact quality of life and shorten life span. As a result of obesity, these individuals are also at a higher risk for developing life-threatening blood clots. Such risk is further elevated with exposure of obese subjects to the stress of surgery. In fact, the most common cause of death after major surgery in morbidly obese subjects is the migration of blood clots to the lung and heart. With the current rise in popularity of weight loss surgery, it has become imperative that we identify a medication that is safe and effective in preventing the formation of blood clots. Fondaparinux has the potential for being an effective anti-clotting drug. It is superior to other similar drugs because it is completely utilized by the body, and has a more predictable action. The problem, however, is that the recommended doses for fondaparinux were obtained after studies on lean individuals. This is a fixed dose that is administered universally, regardless of the size of the subject. Presently, we have no information on what the recommended doses should be for morbidly obese subjects, who are in the most need for effective anti-clotting medication. This study will attempt to determine whether a fixed dose or a weight-related dose is appropriate for morbidly obese subjects, and also investigate the safety of administering weight-based dosing to these individuals. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

• NCT number: NCT00346879
• Study type: Interventional
• Source: Indiana University
• Status: Withdrawn
• Phase: Phase 1
• Start date: August 2006
• Completion date: January 2009