Last updated: 11/07/2018 04:38:38
Special Drug Use Investigation for ARIXTRA® (fondaparinux) Injection
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Special Drug Use Investigation for ARIXTRA® (fondaparinux) Injection
Trial description: This post-marketing surveillance study was designed to collect and assess the information on proper use of fondaparinux injection, such as the safety and efficacy under actual use conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism. (ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The number of incidences of adverse events in Japanese subjects undergoing orthopedic surgery of the lower limb
Timeframe: 3 months
Occurrence of adverse events of bleeding
Timeframe: 3 months
Presence or absence of venous thromboembolism after treatment of fondaparinux
Timeframe: 3 months
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
1280
Primary completion date:
Not applicable
Observational study model:
Other
Time perspective:
Prospective
Clinical publications:
Ichiro Kumegawa, Mihoko Yabuuchi, Kyomi Kanaya, Iwao Suzuki, Yasushi Ozeki, Terufumi Hara. Special Drug Use Investigation of Arixtra Injection (fondaparinux sodium) in Patients Undergoing Lower Limb Orthopedic Surgery. [J Clin Therapeut Med]. 2012;28(6):505-527.
Medical condition
Thromboembolism
Product
fondaparinux sodium
Collaborators
Not applicable
Study date(s)
September 2007 to January 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
No
- Subjects undergo orthopedic surgery of the lower limb at high risk of developing venous thromboembolism
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects undergo orthopedic surgery of the lower limb at high risk of developing venous thromboembolism
Exclusion criteria:
- Not applicable
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2011-20-01
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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