Venous ThromboembolismPhase 3NCT01181141

Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery

A Phase 3 study testing DU-176b (edoxaban) and Enoxaparin sodium 20mg in people with Venous Thromboembolism, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to evaluate the safety and efficacy of DU-176b compared with enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip fracture surgery. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Venous Thromboembolism
What is being tested?: DU-176b (edoxaban) and Enoxaparin sodium 20mg
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 1 siteJapan
Study dates: Oct 2008to Feb 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric)

Who cannot join

Subjects with risks of hemorrhage
Subjects with thrombolic risks
Subjects who weigh less than 40 kg
Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Osaka

Other trials in Japan

About this study

Official title: A Phase 3, Randomized, Open Label, Safety and Efficacy Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery (STARS J-4 Trial)

Conditions: Venous Thromboembolism
Being tested: DU-176b (edoxaban), Enoxaparin sodium 20mg
Keywords: Anticoagulants, Enoxaparin sodium, venous thromboembolism., thromboembolism, Thrombosis, deep vein thrombosis, DU-176b, Edoxaban, factor Xa, hip fracture surgery, embolism
Medical subject headings: Venous Thromboembolism, Thromboembolism, Thrombosis, Venous Thrombosis, Embolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DU-176b (edoxaban)Drug
Enoxaparin sodium 20mgDrug

Study groups in NCT01181141
Study group	Role	What they receive
DU-176b	Experimental	DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery Receives: Drug: DU-176b (edoxaban)
Enoxaparin sodium	Active comparator	Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery Receives: Drug: Enoxaparin sodium 20mg

What is being measured

The primary outcome is the main question the study is designed to answer.

The Incidence of Major or Clinically Relevant Non-major Bleeding
Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints.
Measured: 2 weeks

Secondary outcomes (1)

Proportion of Subjects With Venous Thromboembolism Events.
Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Feb 2010

First posted13 Aug 2010 (estimated)
Study startOct 2008
Primary completionAug 2009
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 92 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01181141
Sponsor's protocol ID: DU176b-B-J303
Status last verified: Feb 2015
First submitted: 12 Aug 2010
Last updated: 5 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Publications

Fuji T, Fujita S, Kawai Y, Nakamura M, Kimura T, Kiuchi Y, Abe K, Tachibana S. Safety and efficacy of edoxaban in patients undergoing hip fracture surgery. Thromb Res. 2014 Jun;133(6):1016-22. doi: 10.1016/j.thromres.2014.03.009. Epub 2014 Mar 6.
PubMed 24680549

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
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All Venous Thromboembolism trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Open Label, Safety and Efficacy Study of the Oral Factor Xa Inhibitor DU-176b Compared With Enoxaparin Sodium for Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery (STARS J-4 Trial)
ClinicalTrials.gov ID: NCT01181141
Acronym / sponsor ID: DU176b-B-J303
Conditions: Venous Thromboembolism
Keywords: Anticoagulants, Enoxaparin sodium, venous thromboembolism., thromboembolism, Thrombosis, deep vein thrombosis, DU-176b, Edoxaban
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 92 participants (actual)
Lead sponsor: Daiichi Sankyo Co., Ltd.Industry (pharma, biotech, devices)
Study start: Oct 2008
Primary completion: Aug 2009 (actual)
Study completion: Feb 2010 (actual)
First posted: 13 Aug 2010 (estimated)
Results: Posted 26 Jan 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
DU-176b	Experimental	Drug: DU-176b (edoxaban)DU-176b oral tablets, 30 mg., taken once daily for 2 weeks, initiated within 6 to 24 hours after surgery
Enoxaparin sodium	Active comparator	Drug: Enoxaparin sodium 20mgEnoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks, initiated within 24 to 36 hours after surgery

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or outer femoral neck (trochanteric and subtrochanteric)

Key exclusion criteria (4 listed)

Subjects with risks of hemorrhage
Subjects with thrombolic risks
Subjects who weigh less than 40 kg
Subjects who are pregnant or suspect pregnancy, or subjects who want to become pregnant

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DU-176b (edoxaban)	Drug	DU-176b
Enoxaparin sodium 20mg	Drug	Enoxaparin sodium

Primary outcome

The Incidence of Major or Clinically Relevant Non-major Bleeding
Time frame: 2 weeks
Bleeding events during the period from the start of treatment with the study drug (study treatment) to the day of the follow-up examination were assessed as the primary endpoints.

1 secondary outcome

Proportion of Subjects With Venous Thromboembolism Events.
Time frame: 2 weeks

Results and safety

Results posted to the registry on 26 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DU-176b	62	50
Enoxaparin Sodium	30	26

Primary outcome: The Incidence of Major or Clinically Relevant Non-major Bleeding

Time frame: 2 weeks. Number (95% Confidence Interval). Unit: percentage of subjects with bleeds

Measure	DU-176b n = 59	Enoxaparin Sodium n = 29
Value	3.4 (0.9 to 11.4)	6.9 (1.9 to 22.0)

DU-176b vs Enoxaparin Sodium: Cox Proportional Hazard: -3.5 (95% CI -18.8 to 6.0), Wilcoxon (Mann-Whitney)

Population analysed: Safety Analysis Set defined as all subjects who were secondarily enrolled in study, but excluded those with significant GCP violations, did not receive any study drug, or had no safety data after start of study treatment. However, subjects who had significant GCP violations, but received at least one dose of study drug, safety data were assessed.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DU-176b	3 of 59 (5.1%)	43 of 59 (72.9%)	Not reported
Enoxaparin Sodium	3 of 29 (10.3%)	24 of 29 (82.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24680549Fuji T, Fujita S, Kawai Y, Nakamura M, Kimura T, Kiuchi Y, Abe K, Tachibana S. Safety and efficacy of edoxaban in patients undergoing hip fracture surgery. Thromb Res. 2014 Jun;133(6):1016-22. doi: 10.1016/j.thromres.2014.03.009. Epub 2014 Mar 6.
Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Related trials for Venous Thromboembolism

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REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
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RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Takeshi Fuji principal investigator

Osaka Kouseinennkin Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DU-176b (edoxaban) and Enoxaparin sodium 20mg in people with Venous Thromboembolism, run by Daiichi Sankyo Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Incidence of Major or Clinically Relevant Non-major Bleeding (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01181141, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.