ArthroplastyPhase 2TEMPESTNCT00041509
ThromboEmbolism Prevention Efficacy and Safety Trial (TEMPEST)
A Phase 2 study testing SB-424323 in people with Arthroplasty, run by GlaxoSmithKline.
Trial summary
The purpose of this study is to gain additional safety information as well as to determine after the study drug has been given to patients who have undergone total hip replacement surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood clots in legs) or pulmonary embolism (blood… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Arthroplasty
- What is being tested?
- SB-424323
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 343 participants
- Where
- No sites listed yet
- Study dates
- Jan 2002to May 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side).
- Patients who have given written informed consent to participate in this study.
Who cannot join
- Patients with a contraindication to contrast venography
- Patients with an increased risk of bleeding.
- Patients with a predefined risk for prethrombotic episodes or a history of thrombophilia.
- Other inclusion or exclusion criteria to be determined by the physician and study sponsor.
About this study
Official title: ThromboEMbolism Prevention Efficacy and Safety Trial (TEMPEST): A Double-blind Four-week Study to Assess the Efficacy, Safety, and Tolerability of SB-424323 in the Extended Prophylaxis of Patients Following Total Hip Arthroplasty
The purpose of this study is to gain additional safety information as well as to determine after the study drug has been given to patients who have undergone total hip replacement surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood clots in legs) or pulmonary embolism (blood clots in lungs).
- Conditions
- Arthroplasty
- Being tested
- SB-424323, Placebo
- Keywords
- venous thromboembolism, thromboembolism, pulmonary embolism, deep vein thrombosis
- Medical subject headings
- Venous Thromboembolism, Thromboembolism, Pulmonary Embolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-424323Drug
500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days
PlaceboDrug
matching placebo, oral, BID for 28 days
| Study group | Role | What they receive |
|---|---|---|
| SB424323, 500 mg BID | Experimental | Not described Receives: Drug: SB-424323 |
| SB424323, 125 mg BID | Experimental | Not described Receives: Drug: SB-424323 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
VTE
Incidence of VTE during the 28-day treatment period, including death due to VTE
Measured: 28 day treatment period
Secondary outcomes (1)
types of VTE
The incidence of the types of VTE including, DVT (deep vein thrombosis), symptomatic VTE, PE] and anti-IIa activity
Measured: 28 day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2002 (estimated)
- Study startJan 2002
- Primary completionMay 2003
- Study completionMay 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041509
- Sponsor's protocol ID
- 424323/025
- Acronym
- TEMPEST
- Status last verified
- May 2017
- First submitted
- 9 Jul 2002
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ThromboEMbolism Prevention Efficacy and Safety Trial (TEMPEST): A Double-blind Four-week Study to Assess the Efficacy, Safety, and Tolerability of SB-424323 in the Extended Prophylaxis of Patients Following Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT00041509
- Acronym / sponsor ID
- TEMPEST / 424323/025
- Conditions
- Arthroplasty
- Keywords
- venous thromboembolism, thromboembolism, pulmonary embolism, deep vein thrombosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- May 2003 (actual)
- Study completion
- May 2003 (actual)
- First posted
- 12 Jul 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to gain additional safety information as well as to determine after the study drug has been given to patients who have undergone total hip replacement surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood clots in legs) or pulmonary embolism (blood clots in lungs).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SB424323, 500 mg BID | Experimental | Drug: SB-424323 |
| SB424323, 125 mg BID | Experimental | Drug: SB-424323 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side).
- Patients who have given written informed consent to participate in this study.
Key exclusion criteria (4 listed)
- Patients with a contraindication to contrast venography
- Patients with an increased risk of bleeding.
- Patients with a predefined risk for prethrombotic episodes or a history of thrombophilia.
- Other inclusion or exclusion criteria to be determined by the physician and study sponsor.
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 |
|---|---|---|
| SB-424323500 mg, oral, BID for 28 days or 125 mg, oral, BID for 28 days | Drug | SB424323, 125 mg BID, SB424323, 500 mg BID |
| Placebomatching placebo, oral, BID for 28 days | Drug | Placebo |
Primary outcome
VTE
Time frame: 28 day treatment period
Incidence of VTE during the 28-day treatment period, including death due to VTE
1 secondary outcome
types of VTE
Time frame: 28 day treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB-424323 in people with Arthroplasty, run by GlaxoSmithKline.
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 2 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 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VTE (time frame: 28 day treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2017.