NCT00320398

Total Hip Replacement 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 Thrombosis, Venous in 114 participants. Completed in 18 July 2006.

Timeline

30 January 2006

Primary endpoint
18 July 2006

18 July 2006

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Primary purpose	prevention
Enrollment	114
Start date	30 January 2006
Primary completion	18 July 2006
Estimated completion	18 July 2006
Sites	1 location

Drugs / interventions tested

• Fondaparinux (FONDAPARINUX) — full drug profile →

Conditions studied

• Thrombosis, Venous — all drugs for Thrombosis, Venous →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

20 and older, any sex, with Thrombosis, Venous. 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.

Percentage of Participants With Venous Thromboembolism (VTE) During Efficacy Period Primary · Up to Day 17

The percentage of participants with VTE, who underwent elective total hip replacement surgery, detected by routine venography, during the treatment period were reported. The percentage VTE was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the Central Independent Adjudication Committee of Efficacy (CI

Group	Value	95% CI
Fondaparinux 1.5 mg	8.3	2.3 – 20.0
Fondaparinux 2.5 mg	2.2	0.1 – 11.5

Percentage of Participants With Major Bleeding Primary · Up to Day 17

Major bleeding defined as any clinically unusual bleeding meeting 1 of following criteria; a)Fatal bleeding; b) Including retroperitoneal and intracranial bleeding, or bleeding into critical organ (eye, adrenal gland, pericardium, spine); c) Reoperation due to bleeding or hematoma at operative site; d)Bleeding leading to hemoglobin (Hb) fall \> = 2 gram per deciliter (g/dL)(1.6 millimole per litre \[mmol/L\]) within 48 hour of the bleed; e)Bleeding that required transfusion of red blood cells (RBCs) or whole blood (WB) derived from \>= 900 milliliter (mL) of WB within 48 hours of the bleed (ex

Group	Value	95% CI
Fondaparinux 1.5 mg	0	0.0 – 6.2
Fondaparinux 2.5 mg	0	0.0 – 6.4

Percentage of Participants With Minor Bleeding Secondary · Up to Day 17

Minor bleeding was defined as the clinically overt bleeding not meeting the criteria for major bleeding like: (Fatal bleed; Including retroperitoneal and intracranial bleeding, or bleed in critical organ \[eye, adrenal gland, pericardium, spine\]; c) Reoperation due to bleeding or hematoma at operative site; d) Bleeding leading to hemoglobin (Hb) fall \> = 2 g/dL(1.6 mmol/L) within 48 hour of the bleed; e)Bleeding that required transfusion of RBCs or WB derived from \>= 900 mL of WB within 48 hours of the bleed (excluding autologous transfusion except for treatment of bleeding adverse event);

Group	Value	95% CI
Fondaparinux 1.5 mg	1.7	0.0 – 9.2
Fondaparinux 2.5 mg	3.6	0.4 – 12.3

Percentage of Participants With All Deep Vein Thrombosis (DVT) Secondary · Up to Day 17

The percentage of participants with All DVT were reported, where the analysis was done using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.

Group	Value	95% CI
Fondaparinux 1.5 mg	8.3
Fondaparinux 2.5 mg	2.2

Percentage of Participants With Proximal DVT Secondary · Up to Day 17

The percentage of participants with DVT (proximal) were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.

Group	Value	95% CI
Fondaparinux 1.5 mg	0
Fondaparinux 2.5 mg	0

Percentage of Participants With Distal Only DVT Secondary · Up to Day 17

The percentage of participants with distal only DVT were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.

Group	Value	95% CI
Fondaparinux 1.5 mg	4
Fondaparinux 2.5 mg	1

Percentage of Participants With Symptomatic DVT During Main Efficacy Period Secondary · Up to Day 17

The percentage of participants with different symptoms of DVT (proximal) like pain or tenderness, swelling, warmth, redness or discoloration, and distention of surface veins, post the total hip replacement surgery were reported, where analysis was done using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure.

Group	Value	95% CI
Fondaparinux 1.5 mg	0
Fondaparinux 2.5 mg	0

Percentage of Participants With Pulmonary Embolism During Efficacy Period Secondary · Up to Day 17

The percentage of participants with pulmonary embolism (pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia ) were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE.

Group	Value	95% CI
Fondaparinux 1.5 mg	0
Fondaparinux 2.5 mg	0

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths Secondary · From first injection of study drug (Day 3) to up to 2 calendar days after last injection (Treatment period), up to Day 17.

An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or signif

Deaths

Group	Value	95% CI
Fondaparinux 1.5 mg	0
Fondaparinux 2.5 mg	0

Any SAE

Group	Value	95% CI
Fondaparinux 1.5 mg	0
Fondaparinux 2.5 mg	0

Any AE

Group	Value	95% CI
Fondaparinux 1.5 mg	49
Fondaparinux 2.5 mg	45

Number of Transfused Participants Secondary · Up to Day 17.

The number of participants who received RBCs or WB after the total hip replacement surgery within 48 hours of bleed were reported.

Group	Value	95% CI
Fondaparinux 1.5 mg	5
Fondaparinux 2.5 mg	2

Volume of Transfusion Secondary · Up to Day 17

The total volume of transfusion (RBCs or WB) received by the participant was reported.

Group	Value	95% CI
Fondaparinux 1.5 mg	400.0	± 0.0
Fondaparinux 2.5 mg	600.0	± 282.8

Adverse events — posted to ClinicalTrials.gov

Time frame: From first injection of study drug (Day 3) to up to 2 calendar days after last injection (Treatment period), up to Day 17.. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Fondaparinux 1.5 mg

Serious: 0/58 (0%)

Deaths: 0/58

Fondaparinux 2.5 mg

Serious: 0/56 (0%)

Deaths: 0/56

Other adverse events (21 terms — click to expand)

Reaction	System	Fondaparinux 1.5 mg	Fondaparinux 2.5 mg
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Insomnia	Psychiatric disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Platelet count increased	Investigations	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Headache	Nervous system disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Gamma glutamyl transferase increased	Investigations	—	—
Dizziness	Nervous system disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Pyrexia	General disorders	—	—
Dermatitis contact	Skin and subcutaneous tissue disorders	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—
Blood alkaline phosphatase increased	Investigations	—	—
Hepatic function abnormal	Hepatobiliary disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Haemorrhoids	Gastrointestinal disorders	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—

Data from ClinicalTrials.gov NCT00320398 adverse events section.

Sponsor's own description

This study is requested by PMDA to confirm the optimal dose for THR (total hip replacement).

Publications & conference data

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