SedationPhase 3NCT00526760
Long-term Clinical Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects
A Phase 3 study testing Dexmedetomidine in people with Sedation, run by Hospira, now a wholly owned subsidiary of Pfizer at 10 sites in Japan.
Trial summary
Evaluate efficacy and safety of dexmedetomidine long term administration in ICU patients who require more than 24 hours sedation. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sedation
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 10 sitesJapan
- Study dates
- Oct 2007to Jun 2008
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient or legally acceptable representative (if acceptable by Institutional Review Board/Ethics Committee) has signed and dated the Informed Consent after the study had been fully explained.
- Patient is male or female, at least 20 years of age.
- In case of surgical ICU patient, who is in condition of American Society of Anesthesiologists (ASA) I to III Class preoperatively.
- Patient is on mechanical ventilation and anticipated to require sedation more than 24 hours following a surgery.
- If patient is female with child bearing potential, she is to be non-pregnant, and not lactating.
Who cannot join
- Patient has serious central nervous system (CNS) trauma.
- Patient requires the use of neuromuscular blocking agents after admission to ICU, except for the insertion of the endotracheal tube.
- Patient is hospitalized for drug overdose within the last 30 days.
- Patient in whom alpha-2 antagonists or alpha-2 agonists are contraindicated.
- Patient is currently being treated or has been treated within the last 30 days with alpha-2 agonist or antagonist.
- Patient has participated in a trial with any experimental drug within 30 days prior to admission to the ICU.
Show all 10Show fewer
- Terminally ill patient, whose life duration expectancy is no more or around 30 days.
- Patient is considered unable to undergo any procedure required by the protocol.
- Patient with excessive bleeding which will likely require surgery.
- In the Investigator's opinion, patient has any symptom or factor, which might increase risk to the patient or preclude obtaining satisfactory study data.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Japan10 sites
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 113-8603
Yamanashi University Hospital
Chūō, Yamanashi, 409-3898
Hamamatsu Medical University Hospital
Hamamatsu, Shizuoka, 431-3192
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, 890-8520
Jikei University Hospital
Minato-ku, Tokyo, 105-8741
Hyogo Medical University Hospital
Nishinomiya, Hyōgo, 663-8501
Kinki University Hospital
Sayama, Osaka, 589-8511
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666
Keio University Hospital
Sinjuku-ku, Tokyo, 160-8582
Osaka University Hospital
Suita, Osaka, 565-0871
About this study
Official title: A Phase 3, Open-Label Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects Requiring Greater Than 24 Hours of Continuous Sedation
Evaluate efficacy and safety of dexmedetomidine long term administration in ICU patients who require more than 24 hours sedation.
Read the detailed description
According to the current dexmedetomidine indication, the duration of dexmedetomidine administration is limited within 24 hours. However, there is a strong demand from the medical specialists for continued administration of dexmedetomidine in excess of 24 hours in the medical practice because a large number of patients require sedation for more than 24 hours in ICU. To meet such clinical demand, it was planned to conduct a phase III long-term administration study of dexmedetomidine to obtain the approval on the infusion of dexmedetomidine for more than 24 hours.
- Conditions
- Sedation
- Being tested
- Dexmedetomidine
- Keywords
- Dexmedetomidine, Sedation, Long-term, Phase 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of adverse drug reactions of hypotension, hypertension and bradycardia which correspond to the protocol definitions
Definition:
- Hypotension: dosing start or dose increase of vasopressor drug or use of fluid bolus ≥500 mL within 1 hour resulting from SBP<60mmHg, DBP<40mmHg or ≥50% lower than baseline.
- Hypertension: dosing start or dose increase of intravenous anti-hypertensive medication resulting from SBP>160, DBP>100 or. ≥50% higher than baseline.
- Bradycardia: dosing start or dose increase of positive chronotropic medication or use of pacemaker resulting from heart rate <40bpm or ≥50% lower than baseline.
Measured: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
Secondary outcomes (4)
Percentage of with a Richmond Agitation-Sedation Sedation Score ≤0 during the study drug infusion
Measured: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
Percentage of time with a Richmond Agitation-Sedation Sedation Score =0, -1,-2 during the study drug infusion
Measured: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
Administration frequency and dosage of additional sedatives
Measured: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
Administration frequency and dosage of additional analgesics
Measured: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Maruishi Pharmaceutical
- Responsible party
- Sponsor
- Investigators
- Misa Kawai, Study director, Hospira, now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526760
- Sponsor's protocol ID
- DEX-402
- Status last verified
- Jun 2015
- First submitted
- 5 Sep 2007
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-Label Study Evaluating the Safety and Efficacy of Dexmedetomidine in ICU Subjects Requiring Greater Than 24 Hours of Continuous Sedation
- ClinicalTrials.gov ID
- NCT00526760
- Acronym / sponsor ID
- DEX-402
- Conditions
- Sedation
- Keywords
- Dexmedetomidine, Sedation, Long-term, Phase 3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospira, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Maruishi Pharmaceutical
- Study start
- Oct 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 10 Sep 2007 (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.
Evaluate efficacy and safety of dexmedetomidine long term administration in ICU patients who require more than 24 hours sedation.
Detailed description
According to the current dexmedetomidine indication, the duration of dexmedetomidine administration is limited within 24 hours. However, there is a strong demand from the medical specialists for continued administration of dexmedetomidine in excess of 24 hours in the medical practice because a large number of patients require sedation for more than 24 hours in ICU. To meet such clinical demand, it was planned to conduct a phase III long-term administration study of dexmedetomidine to obtain the approval on the infusion of dexmedetomidine for more than 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient or legally acceptable representative (if acceptable by Institutional Review Board/Ethics Committee) has signed and dated the Informed Consent after the study had been fully explained.
- Patient is male or female, at least 20 years of age.
- In case of surgical ICU patient, who is in condition of American Society of Anesthesiologists (ASA) I to III Class preoperatively.
- Patient is on mechanical ventilation and anticipated to require sedation more than 24 hours following a surgery.
- If patient is female with child bearing potential, she is to be non-pregnant, and not lactating.
Key exclusion criteria (10 listed)
- Patient has serious central nervous system (CNS) trauma.
- Patient requires the use of neuromuscular blocking agents after admission to ICU, except for the insertion of the endotracheal tube.
- Patient is hospitalized for drug overdose within the last 30 days.
- Patient in whom alpha-2 antagonists or alpha-2 agonists are contraindicated.
- Patient is currently being treated or has been treated within the last 30 days with alpha-2 agonist or antagonist.
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 |
|---|---|---|
| Dexmedetomidine | Drug | Dexmedetomidine |
Primary outcome
Incidence rate of adverse drug reactions of hypotension, hypertension and bradycardia which correspond to the protocol definitions
Time frame: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
Definition: * Hypotension: dosing start or dose increase of vasopressor drug or use of fluid bolus ≥500 mL within 1 hour resulting from SBP<60mmHg, DBP<40mmHg or ≥50% lower than baseline. * Hypertension: dosing start or dose increase of intravenous anti-hypertensive medication resulting from SBP>160, DBP>100 or. ≥50% higher than baseline. * Bradycardia: dosing start or dose increase of positive chronotropic medication or use of pacemaker resulting from heart rate <40bpm or ≥50% lower than baseline.
4 secondary outcomes
Percentage of with a Richmond Agitation-Sedation Sedation Score ≤0 during the study drug infusion
Time frame: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
Percentage of time with a Richmond Agitation-Sedation Sedation Score =0, -1,-2 during the study drug infusion
Time frame: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
Administration frequency and dosage of additional sedatives
Time frame: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
Administration frequency and dosage of additional analgesics
Time frame: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.
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 Jun 2015.
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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.
Misa Kawai study director
Hospira, now a wholly owned subsidiary of Pfizer
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine in people with Sedation, run by Hospira, now a wholly owned subsidiary of Pfizer at 10 sites 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 5 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 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
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?
Incidence rate of adverse drug reactions of hypotension, hypertension and bradycardia which correspond to the protocol definitions (time frame: Prior to study drug infusion, during the study drug infusion and 24 hours after study drug infusion end; maximum ≤28 days.). 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 Jun 2015.