NCT00320424

Hip Fracture Study of GSK576428 (Fondaparinux Sodium)

Completed Phase 3 Results posted Last updated 4 September 2018

What this trial tests

Phase 3 trial testing Fondaparinux in Thromboembolism in 48 participants. Completed in 26 October 2006.

Timeline

16 February 2006

Primary endpoint
26 October 2006

26 October 2006

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	48
Start date	16 February 2006
Primary completion	26 October 2006
Estimated completion	26 October 2006
Sites	1 location

Drugs / interventions tested

• Fondaparinux (FONDAPARINUX) — full drug profile →

Conditions studied

• Thromboembolism — all drugs for Thromboembolism →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

20 and older, any sex, with Thromboembolism. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Rate of Major Bleeding During Treatment Period Primary · From the first study drug injection up to Day 17

Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of venous thromboembolic events (VTE) included, but were not limited to lower extremity deep vein thrombosis (DVT): erythema, warmth, pain, swelling, tenderness and pulmonary embolism (PE): pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administr

Group	Value	95% CI
Fondaparinux Sodium 2.5 mg s.c.	21.6	9.8 – 38.2

Rate of PE During Treatment Period Secondary · Up to Day 17

Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection u

Group	Value	95% CI
Fondaparinux Sodium 2.5 mg s.c.	0	0 – 0

Rate of DVT During Treatment Period Secondary · Up to Day 17

Rate (%) was defined as number of events divided by the number of patients evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.

Group	Value	95% CI
Fondaparinux Sodium 2.5 mg s.c.	21.6

Rate of Proximal DVT During Treatment Period Secondary · Up to Day 17

Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.

Group	Value	95% CI
Fondaparinux Sodium 2.5 mg s.c.	2.6

Rate of Distal Only DVT During Treatment Period Secondary · Up to Day 17

Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.

Group	Value	95% CI
Fondaparinux Sodium 2.5 mg s.c.	21.6

Number of Participants With Major Bleeding During Treatment Period Secondary · From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

Major bleeding events were defined as clinically unusual bleeding meeting any of the following criteria: fatal bleeding, bleeding including retroperitoneal and intracranial bleeding or bleeding into a critical organ (eye, adrenal gland, pericardium, spine), reoperation due to bleeding/hematoma at the operative site, bleeding leading to a hemoglobin (Hb) fall \>=2 grams per deciliter (g/dL, 1.6 millimoles per liter \[mmol/L\]) within 48 hour of the bleed, bleeding that required a transfusion of red blood cell or whole blood derived from \>=900 millilters (mL) of whole blood within 48 hours of t

Group	Value	95% CI
Fondaparinux Sodium 2.5 mg s.c.	0

Number of Participants With Minor Bleeding and Any Bleeding (Major and/or Minor Bleeding) Secondary · From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

Minor bleeding and any bleeding (major and/or minor bleeding) events were adjudicated by the CIACS. Minor bleeding was defined as clinically overt bleeding not meeting the criteria for major bleeding and considered more than expected in the clinical context. Any bleeding (major and/or minor bleeding) could be recorded may be major and/or minor.

Minor Bleeding

Group	Value	95% CI
Fondaparinux Sodium 2.5 mg s.c.	0

Any Bleeding

Group	Value	95% CI
Fondaparinux Sodium 2.5 mg s.c.	0

Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death Secondary · From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threa

Any AE

Group	Value	95% CI
Fondaparinux Sodium 2.5 mg s.c.	37

Any SAE

Group	Value	95% CI
Fondaparinux Sodium 2.5 mg s.c.	2

Death

Group	Value	95% CI
Fondaparinux Sodium 2.5 mg s.c.	0

Number of Transfused Participants Secondary · From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection.

Group	Value	95% CI
Fondaparinux Sodium 2.5 mg s.c.	1

Summary of Units Transfused Secondary · From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection.

Group	Value	95% CI
Fondaparinux Sodium 2.5 mg s.c.	280

Rate of Symptomatic DVT Secondary · Up to Day 17

Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first.

Group	Value	95% CI
Fondaparinux Sodium 2.5 mg s.c.	0

Adverse events — posted to ClinicalTrials.gov

Time frame: AE and SAE were reported throughout the study (from the first study drug injection up to 2 days after the last study drug injection [approximately up to Day 17]).. Reporting threshold: 4%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Fondaparinux Sodium 2.5 mg s.c.

Serious: 2/48 (4%)

Deaths: 0/48

Serious adverse events (2 terms)

Reaction	System	Fondaparinux Sodium 2.5 mg…
Ileus	Gastrointestinal disorders	—
Femur fracture	Injury, poisoning and procedural complications	—

Other adverse events (16 terms — click to expand)

Reaction	System	Fondaparinux Sodium 2.5 mg…
Constipation	Gastrointestinal disorders	—
Insomnia	Psychiatric disorders	—
Oedema peripheral	General disorders	—
Excoriation	Injury, poisoning and procedural complications	—
Dermatitis contact	Skin and subcutaneous tissue disorders	—
Restlessness	Psychiatric disorders	—
Pyrexia	General disorders	—
Blood alkaline phosphatase increased	Investigations	—
Abdominal pain upper	Gastrointestinal disorders	—
Diarrhea	Gastrointestinal disorders	—
C reactive protein increased	Investigations	—
Platelet count increased	Investigations	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—
Erythema	Skin and subcutaneous tissue disorders	—
Nasopharyngitis	Infections and infestations	—

Most-reported serious reactions: Ileus, Femur fracture.

Data from ClinicalTrials.gov NCT00320424 adverse events section.

Sponsor's own description

This study is requested by PMDA to confirm the efficacy and the safety for HFS.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.