Arthroplasty, Replacement, HipPhase 2NCT00107900

Study of the Efficacy and Safety of DU-176b in Preventing Blood Clots in Patients Undergoing Total Hip Replacement

A Phase 2 study testing DU-176b in people with Arthroplasty, Replacement, Hip and Thrombosis, run by Daiichi Sankyo at 1 site in United States.

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

Patients who undergo total hip replacement surgery are at greater risk of getting deep vein thrombosis (blood clots). This study evaluates the safety, tolerability and effectiveness of the study drug, DU-176b, in reducing the occurrence of deep vein thrombosis in patients having total hip replacement surgery. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Arthroplasty, Replacement, Hip, Thrombosis
What is being tested?: DU-176b
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 606 participants
Where: 1 siteUnited States
Study dates: Jan 2005to Dec 2005
Phase: Phase 2
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Unilateral hip replacement

Who cannot join

Patients scheduled for bilateral hip replacement in same procedure
Patients with increased risk of bleeding
Uncontrolled hypertension (BP greater than 180/100 mmHg)
Patients less than 111 lbs or more than 243 lbs
Patients on long-term anticoagulants
Patients with contraindications to venography

Show all 10Show fewer

Patients with medical history of venous thromboembolism
Patients with impaired hepatic function
Known to be pregnant
Lactating women

Trial locations and contacts

1 site in 1 country.

United States1 site

Local Institution
Decatur, Georgia, 30033

Other trials in United States

About this study

Official title: A Phase IIa, Multi-center, Multi-national, Open Label, Dose Ranging Study of the Efficacy, Safety, and Tolerability of Oral DU-176b Administered Once or Twice Daily in the Treatment of Adult Patients Undergoing Total Hip Arthroplasty

Read the detailed description

The primary study objective is to demonstrate prevention of venous thromboembolism in patients undergoing total hip replacement surgery. The secondary objective is to assess the safety and tolerability of DU-176.

Conditions: Arthroplasty, Replacement, Hip, Thrombosis
Being tested: DU-176b
Keywords: Deep Vein Thrombosis,, Anticoagulant,, Venous thromboembolic
Medical subject headings: Thrombosis, Venous Thrombosis

What participants receive

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

DU-176bDrug

Study groups in NCT00107900
Study group	Role	What they receive
15mg BID	Experimental	15mg edoxaban administered twice daily (BID) Receives: Drug: DU-176b
30mg QD	Experimental	30mg edoxaban administered once daily (QD) Receives: Drug: DU-176b
30mg BID	Experimental	30mg edoxaban administered twice daily (BID) Receives: Drug: DU-176b
60mg QD	Experimental	60mg edoxaban administered once daily (QD) Receives: Drug: DU-176b
60mg BID	Experimental	60mg edoxaban administered twice daily (BID) Receives: Drug: DU-176b
120mg QD	Experimental	120mg edoxaban administered once daily (QD) Receives: Drug: DU-176b

What is being measured

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

Prevention of Venous Thromboembolism (VTE)
The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment (approximately 2 weeks post surgery).
Confirmed deep vein thrombosis ( both proximal and distal ) as assessed by unilateral or bilateral ascending contrast venograms 7 to 10 days following surgery Symptomatic and objectively proven Pulmonary Embolism (PE) prior to venography Symptomatic and objectively proven Deep Vein Thrombosis (DVT) prior to venography
Measured: 2 weeks

Secondary outcomes (3)

Change From Baseline for Prothrombin Time (PT) Results
Intent to Treat (ITT) population
Measured: end of treatment
Change From Baseline for International Normalized Ratio (INR) Results
Intent to Treat (ITT) population
Measured: end of treatment
Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results
Intent to Treat (ITT) population
Measured: end of treatment

Timeline

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

Jan 2005Dec 2005

First posted12 Apr 2005 (estimated)
Study startJan 2005
Primary completionDec 2005
Study completionDec 2005

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.
Other trials for Arthroplasty, Replacement, HipStudies of the same condition, open and under way.
More trials run by Daiichi SankyoThe sponsor's other registered studies.
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 2
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 606 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00107900
Sponsor's protocol ID: DU176b-PRT007
Status last verified: Feb 2015
First submitted: 11 Apr 2005
Last updated: 26 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
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/

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

Enrolling by invitation
Comparison of Functional Results of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Young Patients
Arthroplasties, Hip Replacement
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
RecruitingObservational study
The restor3d Outcomes Registry
Joint Replacement, Arthropathy
Not yet recruitingObservational study
Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
Osteoarthritis (Knee / Hip), Sarcopenia
RecruitingPhase 4
Low-Volume Pericapsular Nerve Group (PENG) Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip Arthroplasty
Pain, Postoperative, Muscle Weakness

All Arthroplasty, Replacement, Hip trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa, Multi-center, Multi-national, Open Label, Dose Ranging Study of the Efficacy, Safety, and Tolerability of Oral DU-176b Administered Once or Twice Daily in the Treatment of Adult Patients Undergoing Total Hip Arthroplasty
ClinicalTrials.gov ID: NCT00107900
Acronym / sponsor ID: DU176b-PRT007
Conditions: Arthroplasty, Replacement, Hip, Thrombosis
Keywords: Deep Vein Thrombosis,, Anticoagulant,, Venous thromboembolic
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 606 participants (actual)
Lead sponsor: Daiichi SankyoIndustry (pharma, biotech, devices)
Study start: Jan 2005
Primary completion: Dec 2005 (actual)
Study completion: Dec 2005 (actual)
First posted: 12 Apr 2005 (estimated)
Results: Posted 2 Mar 2015

Clinical summary

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

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
15mg BID	Experimental	Drug: DU-176b15mg edoxaban administered twice daily (BID)
30mg QD	Experimental	Drug: DU-176b30mg edoxaban administered once daily (QD)
30mg BID	Experimental	Drug: DU-176b30mg edoxaban administered twice daily (BID)
60mg QD	Experimental	Drug: DU-176b60mg edoxaban administered once daily (QD)
60mg BID	Experimental	Drug: DU-176b60mg edoxaban administered twice daily (BID)
120mg QD	Experimental	Drug: DU-176b120mg edoxaban administered once daily (QD)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Unilateral hip replacement

Key exclusion criteria (10 listed)

Patients scheduled for bilateral hip replacement in same procedure
Patients with increased risk of bleeding
Uncontrolled hypertension (BP greater than 180/100 mmHg)
Patients less than 111 lbs or more than 243 lbs
Patients on long-term anticoagulants

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	Drug	120mg QD, 15mg BID, 30mg BID, 30mg QD, 60mg BID, 60mg QD

Primary outcome

Prevention of Venous Thromboembolism (VTE)
Time frame: 2 weeks
The primary efficacy endpoint was the proportion of subjects who experienced at least one of the thromboembolic events listed below during the period from the start of study treatment to the venography at the end of study treatment (approximately 2 weeks post surgery). Confirmed deep vein thrombosis ( both proximal and distal ) as assessed by unilateral or bilateral ascending contrast venograms 7 to 10 days following surgery Symptomatic and objectively proven Pulmonary Embolism (PE) prior to venography Symptomatic and objectively proven Deep Vein Thrombosis (DVT) prior to venography

3 secondary outcomes

Change From Baseline for Prothrombin Time (PT) Results
Time frame: end of treatment
Change From Baseline for International Normalized Ratio (INR) Results
Time frame: end of treatment
Change From Baseline for Activated Partial Thromboplastin Time (aPTT) Results
Time frame: end of treatment

Results and safety

Results posted to the registry on 2 Mar 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
15mg BID	85	75
30mg QD	75	72
30mg BID	129	104
60mg QD	99	87
60mg BID	115	94
120mg QD	103	94

Primary outcome: Prevention of Venous Thromboembolism (VTE)

Time frame: 2 weeks. Number (90% Confidence Interval). Unit: percentage of patients with event

Measure	15mg BID n = 68	30mg QD n = 65	30mg BID n = 97	60mg QD n = 73	60mg BID n = 84	120mg QD n = 80
Value	13 (11.7 to 28.7)	13 (12.3 to 29.9)	10 (5.7 to 16.9)	13 (10.9 to 26.8)	16 (12.3 to 27.5)	17 (14.0 to 30.2)

15mg BID vs 30mg QD vs 30mg BID vs 60mg QD vs 60mg BID vs 120mg QD: p = 0.238, Fisher Exact

Population analysed: modified ITT population

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
15mg BID	4 of 85 (4.7%)	24 of 85 (28.2%)	Not reported
30mg QD	3 of 75 (4%)	19 of 75 (25.3%)	Not reported
30mg BID	9 of 129 (7%)	65 of 129 (50.4%)	Not reported
60mg QD	10 of 99 (10.1%)	56 of 99 (56.6%)	Not reported
60mg BID	10 of 115 (8.7%)	66 of 115 (57.4%)	Not reported
120mg QD	4 of 103 (3.9%)	34 of 103 (33%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 Arthroplasty, Replacement, Hip

Enrolling by invitation
Comparison of Functional Results of ADM X3-MoP Cup (Stryker) and a CoC Cup (Zimmer) in Young Patients
Arthroplasties, Hip Replacement
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
RecruitingObservational study
The restor3d Outcomes Registry
Joint Replacement, Arthropathy
Not yet recruitingObservational study
Preoperative Muscle Stiffness, Functional Reserve, and Postoperative Quality of Recovery in Lower Extremity Arthroplasty
Osteoarthritis (Knee / Hip), Sarcopenia
RecruitingPhase 4
Low-Volume Pericapsular Nerve Group (PENG) Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip Arthroplasty
Pain, Postoperative, Muscle Weakness

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DU-176b in people with Arthroplasty, Replacement, Hip and Thrombosis, run by Daiichi Sankyo at 1 site in United States.

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 10 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 26 Feb 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 2 Mar 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?

Prevention of Venous Thromboembolism (VTE) (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 NCT00107900.

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 26 Feb 2019.